Degenerative Disc Disease (DDD)INFO SPINENCT07615491

PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials

An observational study of Degenerative Disc Disease (DDD) and Spinal Stenosis, run by Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co. at 3 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis
What is being tested?: Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK) and Titania® Posterior Cervical Stabilization System
Type of treatment: Medical device
How many people: 561 participants
Where: 3 sitesTurkey (Türkiye)
Study dates: 27 Apr 2026to 26 Sep 2028
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients aged 18 years or older who underwent cervical or thoracolumbar spinal instrumentation and/or fusion surgery under current medical practice with appropriate indications, in whom at least one of the investigational devices was used, and who meet all inclusion and no exclusion criteria. The study will enroll a total of 561 subjects across 17 product groups (33 subjects per group, accounting for a 10% dropout rate) at 3 centers in Turkey. All patients who underwent reverse shoulder arthroplasty or hemiarthroplasty using Tıpmed™ Primary Hip Prosthesis Systems, who were informed about this study and voluntarily agreed to participate will be included.

Who may be able to join

18 years of age or older.
Skeletally mature.
Male or female.
Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice.
Titania® spinal stabilization/fusion systems and/or BONEGRAFT® bone cements or BONEGRAFT® bone graft materials used during the operation.
No general health condition contraindicating surgery.
No legal restriction (military service, incarceration, or equivalent).
Provision of signed and dated Informed Consent Form (ICF)

Who cannot join

Participation in another interventional clinical investigation
Suspected or confirmed pregnancy
Morbid obesity
Neurological or psychiatric conditions preventing compliance with postoperative care and instructions
Active spinal or systemic infection
High fever or leukocytosis

Show all 11Show fewer

Severe osteoporosis and/or disease affecting bone metabolism
Known allergy or hypersensitivity to PEEK, Titanium, or PMMA
Congenital abnormality, tumor, or other condition preventing secure implant fixation or likely to shorten implant useful life
Inadequate tissue coverage at the operative site
Legally restricted individuals (military personnel, prisoners, etc.)

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Burak Tülü, Sponsor's Representative contact

+90 (236) 213 10 14

b.tulu@metrosan.com.tr

Turkey (Türkiye)3 sites, 3 recruiting

Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery
Izmir, 35150
Hasan Kamil Sucu, Professor, +90 (505) 211 8744, hksucu@gmail.com
Hasan Kamil Sucu, Professor
Recruiting
Demokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neurosurgery
Izmir, 35390
Gorkem Yavas, Asst. Prof., +90 (537) 331 1559, gorkemyavas@gmail.com
Gorkem Yavas, Asst. Prof.
Not yet recruiting
Van Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery
Van, 65000
Mehmet Edip Akyol, Assoc. Prof., +90 (532) 168 2165, mehmetedipakyol@yyu.edu.tr
Mehmet Edip Akyol, Assoc. Prof.
Not yet recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: A Prospective, Multi-Center, Observational Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials Used in Spinal Instrumentation and Fusion Surgery

This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems, and Bonegraft® bone filling materials (synthetic bone grafts and bone cements). The study aims to evaluate short-term (12-month) safety and effectiveness, identify previously unknown side effects, monitor defined complications, and assess risks based on real-world evidence in patients undergoing spinal surgery. All investigated products are used within their intended purpose under routine clinical practice.

Read the detailed description

This prospective, multi-center, observational study evaluates the safety and clinical performance of Titania® spinal instrumentation and fusion systems (manufactured by METROSAN End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Sti.) and Bonegraft® bone filling materials, including synthetic bone grafts and bone cements (manufactured by Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.). All investigational products are CE marked and registered in the Turkish Ministry of Health's Product Tracking System (UTS).

The study is purely observational; no additional medical procedures, interventions, or tests beyond routine clinical practice will be performed. Data collection includes retrospective review of preoperative and intraoperative information from patient files, followed by prospective follow-up data collection using a study-specific Electronic Case Report Form (e-CRF). Subjects will be evaluated during routine clinical visits at post-operative Day 12 (±5 days), Week 6, and Months 3, 6, and 12.

Seventeen distinct product groups are evaluated independently, covering cervical interbody fusion cages (Titanium and PEEK), posterior cervical stabilization systems, cervical plate systems, cervical dynamic stabilization systems, cervical disc prostheses (Titanium and PEEK), lumbar interbody fusion cages (Titanium and PEEK), interspinous fusion devices, posterior thoracolumbar stabilization systems, posterior thoracolumbar clamp systems, thoracolumbar dynamic stabilization systems, and bone filling materials (bone cements and synthetic bone grafts).

The enrollment period is planned for 12 months, followed by a 12-month follow-up for each participant. An additional 5 months is allocated for data analysis and reporting, with a total study duration of 29 months. The total estimated enrollment is 561 subjects.

The study is conducted in accordance with the EU Medical Device Regulation (MDR) 2017/745, the Turkish Medical Device Regulation (dated 02.06.2021), ICH-GCP guidelines, the Declaration of Helsinki, and applicable Turkish legislation regarding the protection of personal data.

Conditions: Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities, Spinal Tumors, Spinal Infections
Being tested: Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System, Titania® Cervical Plate System, Titania® Cervical Dynamic Stabilization System (Elastic Rod)
Keywords: Post-Market Clinical Follow-Up (PMCF), Spinal Instrumentation, Spinal Fusion, Interbody Fusion, Spinal Stabilization, Spinal Cages, Pedicle Screws, Cervical Plate System, Interspinous Fusion Device, Spinal Implants, Synthetic Bone Graft, Bone Cement
Medical subject headings: Intervertebral Disc Degeneration, Spinal Stenosis, Spondylolisthesis, Spinal Cord Neoplasms, Spinal Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Titania® Cervical Interbody Fusion Cage (Titanium)Device
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Interbody Fusion Cage (PEEK)Device
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Posterior Cervical Stabilization SystemDevice
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Plate SystemDevice
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Dynamic Stabilization System (Elastic Rod)Device
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Disc Prosthesis (Titanium)Device
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Disc Prosthesis (PEEK)Device
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Lumbar Interbody Fusion Cages (Titanium)Device
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Lumbar Interbody Fusion Cages (PEEK)Device
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Interspinous Fusion Device (Titanium)Device
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Posterior Thoracolumbar Stabilization SystemsDevice
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Posterior Thoracolumbar Clamp SystemsDevice
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Thoracolumbar Dynamic Stabilization System (Elastic Rod)Device
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Bonegraft® Synthetic Bone GraftsDevice
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Bonegraft® Bone CementDevice
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Neck Disability Index (NDI) score from baseline (for Cervical Spinal Instrumentation and Fusion Systems)
The NDI is used to evaluate neck-pain-related disability. It consists of 10 items, each scored from 0 to 5. While the total raw score ranges from 0 to 50, results are expressed as a percentage (0-100%) for clinical evaluation, consistent with the referenced literature (Heller et al., 2009). Following clinical benchmarks, a reduction of ≥15% in the NDI score at the 12th-month follow-up compared to baseline is defined as a successful clinical improvement.
Measured: [12 months]
Change in Oswestry Disability Index (ODI) score from baseline (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
The ODI is used to assess the impact of thoracolumbar pain on daily life activities (personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and travel). It consists of 10 items, each scored from 0 to 5. The total score is calculated using the formula: (total score x 100) / (5 x number of questions answered), resulting in a scale from 0 (best) to 100 (worst). Evaluations will be performed at baseline (pre-op) and at each follow-up visit (Day 12, Week 6, and Months 3, 6, and 12).
A reduction of ≥15 points in the ODI score at the 12th-month follow-up compared to baseline is defined as a successful clinical improvement.
Measured: [12 months]
Fusion rate for Spinal Fusion Systems
Fusion status will be evaluated using radiographs and/or CT scans (if available) at each postoperative follow-up visit. The assessment is based on the presence of a continuous trabecular bone bridge between the vertebral bodies. Fusion will be categorized into three groups:
Solid Fusion: Presence of a continuous bone bridge between the vertebrae.
Fibrous Fusion: Absence of a continuous bone bridge, but no signs of instability (translation < 3 mm on dynamic radiographs).
Non-fusion: Absence of a continuous bone bridge along with abnormal motion (> 3 mm translation on radiographs).
The evaluation will be concluded once solid fusion is achieved.
Measured: [12 months]
Adjacent segment motion in subjects with dynamic instrumentation
In subjects undergoing dynamic posterior stabilization, motion at the adjacent segments will be evaluated using flexion and extension radiographs (if available) at all follow-up visits. The primary assessment involves measuring the differences in the disc space angles. These measurements will be compared with baseline (preoperative) values to monitor changes in adjacent segment mobility over the 12-month follow-up period.
Measured: [12 months]
Change in Intervertebral Disc Height
The intervertebral disc height will be evaluated at each follow-up visit using the Dabbs method. The assessment is based on the average of the measurements taken from the anterior and posterior regions of the disc space, expressed in millimeters (mm) by the formula (A+B)/2. These radiological measurements will be compared with preoperative (baseline) values to identify any changes in disc height throughout the 12-month follow-up period.
Measured: [12 months]
Assessment of Intervertebral Disc Degeneration
Intervertebral disc degeneration will be evaluated at each follow-up visit using the Pfirrmann Classification system. This system grades the degree of disc degeneration based on MRI (Magnetic Resonance Imaging) findings, focusing on disc structure, distinction between nucleus and annulus, signal intensity, and disc height. The scale ranges from Grade I (normal disc structure with high signal intensity) to Grade V (severe degeneration with collapsed disc space). Categorical grades obtained at each control period will be compared with baseline (preoperative) status to monitor the progression or stabilization of disc degeneration throughout the 12-month follow-up period, where a shift toward higher grades signifies worsening of degeneration.
Measured: 12 months
Cervical and segmental lordosis assessment (for Cervical Spinal Instrumentation and Fusion Systems)
Cervical and segmental lordosis will be evaluated at each follow-up visit and compared with preoperative measurements. Lateral radiographs of the cervical spine will be used to measure lordosis angles using the Cobb angle method. This assessment aims to monitor the maintenance or restoration of the sagittal alignment of the cervical spine and the specific treated segments throughout the 12-month follow-up period.
Measured: [12 months]
Lordosis restoration and sagittal balance assessment (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
Sagittal balance and lordosis restoration will be evaluated using full-spine radiographs (tele-radiographies, if available) at baseline and each follow-up visit (Day 12, Week 6, Months 3, 6, and 12). Clinical success will be assessed based on the Schwab sagittal alignment classification parameters. This assessment is a categorical evaluation based on whether patients achieve the predefined optimal correction thresholds for three key spinal parameters: 1) Sagittal Vertical Axis (SVA) < 50 millimeters, 2) Pelvic Tilt (PT) < 20 degrees, and 3) Pelvic Incidence minus Lumbar Lordosis (PI-LL) mismatch within ±9 degrees. At each follow-up period, patients will be categorized into two groups: those who achieve all these optimal parameters and those who do not. Patients meeting all three thresholds will be classified as 'successful' according to the Schwab criteria.
Measured: [12 months]
Incidence of adverse events and complications
Safety data will be collected by recording all adverse events (AEs) and complications encountered during the 12-month follow-up period. This includes intraoperative complications, device-related failures, and any postoperative adverse events (e.g., infection, neurological deficit, or reoperation).
Measured: [12 months]

Secondary outcomes (4)

Clinical outcome assessment using Odom's Criteria
Patient clinical outcomes will be evaluated at each follow-up visit using Odom's Criteria, which classifies results as 'Excellent', 'Good', 'Fair', or 'Poor' based on symptom relief and the ability to perform daily activities. Clinical success is defined as the proportion of subjects achieving 'Excellent' or 'Good' scores, representing significant improvement compared to baseline.
Measured: [12 months]
Assessment of pain using Visual Analog Scale (VAS)
Pain intensity and changes in pain levels will be evaluated at each follow-up visit using the Visual Analog Scale (VAS) and compared with baseline measurements. Patients mark their pain level on a 100 mm (or 10 cm) line, where 0 represents no pain and 100 represents the worst pain. A decrease of ≥20 mm (or 2 cm) in pain intensity at the 12th-month follow-up compared to baseline is considered a successful clinical outcome.
Measured: [12 months]
Assessment of health-related quality of life with SF-12
Health-related quality of life and changes in quality of life perception will be evaluated at each follow-up visit using the SF-12 Health Survey and compared with baseline measurements. Each domain of the survey is evaluated independently. Scores for each domain range from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
Measured: [12 months]
Patient satisfaction assessment
Patient satisfaction will be evaluated at the final follow-up visit (12 months) using a 3-point Likert scale based on three specific questions directed to the subject. The scale consists of three response options: 'Yes', 'Undecided', and 'No'. The proportion of patients responding 'Yes' to the satisfaction questions will be analyzed to determine the overall treatment satisfaction rate.
Measured: [12 months]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 202626 Sep 2028

First posted29 May 2026
Study start27 Apr 2026
Primary completion26 Apr 2028 (estimated)
Study completion26 Sep 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Degenerative Disc Disease (DDD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 561 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07615491
Sponsor's protocol ID: INFO SPINE
Other IDs: 2025-223
Acronym: INFO SPINE
Status last verified: May 2026
First submitted: 18 May 2026
Last updated: 29 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will not be shared due to confidentiality and intellectual property policies of the sponsor.

Interested in taking part?

Burak Tülü, Sponsor's Representative

+90 (236) 213 10 14

b.tulu@metrosan.com.tr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Degenerative Disc Disease (DDD) trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center, Observational Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials Used in Spinal Instrumentation and Fusion Surgery
ClinicalTrials.gov ID: NCT07615491
Acronym / sponsor ID: INFO SPINE / INFO SPINE
Conditions: Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities, Spinal Tumors, Spinal Infections
Keywords: Post-Market Clinical Follow-Up (PMCF), Spinal Instrumentation, Spinal Fusion, Interbody Fusion, Spinal Stabilization, Spinal Cages, Pedicle Screws, Cervical Plate System
Study type: Observational
Recruitment status: Recruiting
Enrolment: 561 participants (estimated)
Lead sponsor: Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.Industry (pharma, biotech, devices)
Collaborators: Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.
Study start: 27 Apr 2026 (actual)
Primary completion: 26 Apr 2028 (estimated)
Study completion: 26 Sep 2028 (estimated)
First posted: 29 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 17

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients aged 18 years or older who underwent cervical or thoracolumbar spinal instrumentation and/or fusion surgery under current medical practice with appropriate indications, in whom at least one of the investigational devices was used, and who meet all inclusion and no exclusion criteria. The study will enroll a total of 561 subjects across 17 product groups (33 subjects per group, accounting for a 10% dropout rate) at 3 centers in Turkey. All patients who underwent reverse shoulder arthroplasty or hemiarthroplasty using Tıpmed™ Primary Hip Prosthesis Systems, who were informed about this study and voluntarily agreed to participate will be included.

Key inclusion criteria (8 listed)

18 years of age or older.
Skeletally mature.
Male or female.
Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice.
Titania® spinal stabilization/fusion systems and/or BONEGRAFT® bone cements or BONEGRAFT® bone graft materials used during the operation.

Key exclusion criteria (11 listed)

Participation in another interventional clinical investigation
Suspected or confirmed pregnancy
Morbid obesity
Neurological or psychiatric conditions preventing compliance with postoperative care and instructions
Active spinal or systemic infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Titania® Cervical Interbody Fusion Cage (Titanium)This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Cervical Interbody Fusion Cages (Titanium)
Titania® Cervical Interbody Fusion Cage (PEEK)This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Cervical Interbody Fusion Cages (PEEK)
Titania® Posterior Cervical Stabilization SystemThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Posterior Cervical Stabilization Systems
Titania® Cervical Plate SystemThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Cervical Plate Systems
Titania® Cervical Dynamic Stabilization System (Elastic Rod)This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Cervical Dynamic Stabilization Systems (Elastic Rod)
Titania® Cervical Disc Prosthesis (Titanium)This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Cervical Disc Prosthesis (Titanium)
Titania® Cervical Disc Prosthesis (PEEK)This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Cervical Disc Prosthesis (PEEK)
Titania® Lumbar Interbody Fusion Cages (Titanium)This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Lumbar Interbody Fusion Cages (Titanium)
Titania® Lumbar Interbody Fusion Cages (PEEK)This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Lumbar Interbody Fusion Cages (PEEK)
Titania® Interspinous Fusion Device (Titanium)This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Interspinous Fusion Device (Titanium)
Titania® Posterior Thoracolumbar Stabilization SystemsThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Posterior Thoracolumbar Stabilization Systems
Titania® Posterior Thoracolumbar Clamp SystemsThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Posterior Thoracolumbar Clamp Systems
Titania® Thoracolumbar Dynamic Stabilization System (Elastic Rod)This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)
Bonegraft® Synthetic Bone GraftsThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Synthetic Bone Grafts (Cervical Application), Synthetic Bone Grafts (Thoracolumbar Application)
Bonegraft® Bone CementThis is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.	Device	Bone Cement (Cervical Application), Bone Cement (Thoracolumbar Application)

Primary outcome

Change in Neck Disability Index (NDI) score from baseline (for Cervical Spinal Instrumentation and Fusion Systems)
Time frame: [12 months]
The NDI is used to evaluate neck-pain-related disability. It consists of 10 items, each scored from 0 to 5. While the total raw score ranges from 0 to 50, results are expressed as a percentage (0-100%) for clinical evaluation, consistent with the referenced literature (Heller et al., 2009). Following clinical benchmarks, a reduction of ≥15% in the NDI score at the 12th-month follow-up compared to baseline is defined as a successful clinical improvement.
Change in Oswestry Disability Index (ODI) score from baseline (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
Time frame: [12 months]
The ODI is used to assess the impact of thoracolumbar pain on daily life activities (personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and travel). It consists of 10 items, each scored from 0 to 5. The total score is calculated using the formula: (total score x 100) / (5 x number of questions answered), resulting in a scale from 0 (best) to 100 (worst). Evaluations will be performed at baseline (pre-op) and at each follow-up visit (Day 12, Week 6, and Months 3, 6, and 12). A reduction of ≥15 points in the ODI score at the 12th-month follow-up compared to baseline is defined as a successful clinical improvement.
Fusion rate for Spinal Fusion Systems
Time frame: [12 months]
Fusion status will be evaluated using radiographs and/or CT scans (if available) at each postoperative follow-up visit. The assessment is based on the presence of a continuous trabecular bone bridge between the vertebral bodies. Fusion will be categorized into three groups: Solid Fusion: Presence of a continuous bone bridge between the vertebrae. Fibrous Fusion: Absence of a continuous bone bridge, but no signs of instability (translation < 3 mm on dynamic radiographs). Non-fusion: Absence of a continuous bone bridge along with abnormal motion (> 3 mm translation on radiographs). The evaluation will be concluded once solid fusion is achieved.
Adjacent segment motion in subjects with dynamic instrumentation
Time frame: [12 months]
In subjects undergoing dynamic posterior stabilization, motion at the adjacent segments will be evaluated using flexion and extension radiographs (if available) at all follow-up visits. The primary assessment involves measuring the differences in the disc space angles. These measurements will be compared with baseline (preoperative) values to monitor changes in adjacent segment mobility over the 12-month follow-up period.
Change in Intervertebral Disc Height
Time frame: [12 months]
The intervertebral disc height will be evaluated at each follow-up visit using the Dabbs method. The assessment is based on the average of the measurements taken from the anterior and posterior regions of the disc space, expressed in millimeters (mm) by the formula (A+B)/2. These radiological measurements will be compared with preoperative (baseline) values to identify any changes in disc height throughout the 12-month follow-up period.
Assessment of Intervertebral Disc Degeneration
Time frame: 12 months
Intervertebral disc degeneration will be evaluated at each follow-up visit using the Pfirrmann Classification system. This system grades the degree of disc degeneration based on MRI (Magnetic Resonance Imaging) findings, focusing on disc structure, distinction between nucleus and annulus, signal intensity, and disc height. The scale ranges from Grade I (normal disc structure with high signal intensity) to Grade V (severe degeneration with collapsed disc space). Categorical grades obtained at each control period will be compared with baseline (preoperative) status to monitor the progression or stabilization of disc degeneration throughout the 12-month follow-up period, where a shift toward higher grades signifies worsening of degeneration.
Cervical and segmental lordosis assessment (for Cervical Spinal Instrumentation and Fusion Systems)
Time frame: [12 months]
Cervical and segmental lordosis will be evaluated at each follow-up visit and compared with preoperative measurements. Lateral radiographs of the cervical spine will be used to measure lordosis angles using the Cobb angle method. This assessment aims to monitor the maintenance or restoration of the sagittal alignment of the cervical spine and the specific treated segments throughout the 12-month follow-up period.
Lordosis restoration and sagittal balance assessment (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
Time frame: [12 months]
Sagittal balance and lordosis restoration will be evaluated using full-spine radiographs (tele-radiographies, if available) at baseline and each follow-up visit (Day 12, Week 6, Months 3, 6, and 12). Clinical success will be assessed based on the Schwab sagittal alignment classification parameters. This assessment is a categorical evaluation based on whether patients achieve the predefined optimal correction thresholds for three key spinal parameters: 1) Sagittal Vertical Axis (SVA) < 50 millimeters, 2) Pelvic Tilt (PT) < 20 degrees, and 3) Pelvic Incidence minus Lumbar Lordosis (PI-LL) mismatch within ±9 degrees. At each follow-up period, patients will be categorized into two groups: those who achieve all these optimal parameters and those who do not. Patients meeting all three thresholds will be classified as 'successful' according to the Schwab criteria.
Incidence of adverse events and complications
Time frame: [12 months]
Safety data will be collected by recording all adverse events (AEs) and complications encountered during the 12-month follow-up period. This includes intraoperative complications, device-related failures, and any postoperative adverse events (e.g., infection, neurological deficit, or reoperation).

4 secondary outcomes

Clinical outcome assessment using Odom's Criteria
Time frame: [12 months]
Assessment of pain using Visual Analog Scale (VAS)
Time frame: [12 months]
Assessment of health-related quality of life with SF-12
Time frame: [12 months]
Patient satisfaction assessment
Time frame: [12 months]

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Individual participant dataSharing planned: No. Data will not be shared due to confidentiality and intellectual property policies of the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Burak Tülü, Sponsor's Representative contact

+90 (236) 213 10 14

b.tulu@metrosan.com.tr

Hasan Kamil Sucu, Professor study director

Izmir Katip Celebi University Ataturk Training and Research Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Disc Disease (DDD) and Spinal Stenosis, run by Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co. at 3 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Burak Tülü, Sponsor's Representative (+90 (236) 213 10 14, b.tulu@metrosan.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Neck Disability Index (NDI) score from baseline (for Cervical Spinal Instrumentation and Fusion Systems) (time frame: [12 months]). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07615491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

Study group	Role	What they receive
Cervical Interbody Fusion Cages (Titanium)		Subjects undergoing surgery with "Titania® Cervical Interbody Fusion Cages (Titanium)" will be followed for 12 months. Receives: Device: Titania® Cervical Interbody Fusion Cage (Titanium)
Cervical Interbody Fusion Cages (PEEK)		Subjects undergoing surgery with "Titania® Cervical Interbody Fusion Cages (PEEK)" will be followed for 12 months. Receives: Device: Titania® Cervical Interbody Fusion Cage (PEEK)
Posterior Cervical Stabilization Systems		Subjects undergoing surgery with "Titania® Posterior Cervical Stabilization Systems" will be followed for 12 months. Receives: Device: Titania® Posterior Cervical Stabilization System
Cervical Plate Systems		Subjects undergoing surgery with "Titania® Cervical Plate System" will be followed for 12 months. Receives: Device: Titania® Cervical Plate System
Cervical Dynamic Stabilization Systems (Elastic Rod)		Subjects undergoing surgery with "Titania® Cervical Dynamic Stabilization Systems (Elastic Rod)" will be followed for 12 months. Receives: Device: Titania® Cervical Dynamic Stabilization System (Elastic Rod)
Cervical Disc Prosthesis (Titanium)		Subjects undergoing surgery with "Titania® Cervical Disc Prosthesis (Titanium)" will be followed for 12 months. Receives: Device: Titania® Cervical Disc Prosthesis (Titanium)
Cervical Disc Prosthesis (PEEK)		Subjects undergoing surgery with "Titania® Cervical Disc Prosthesis (PEEK)" will be followed for 12 months. Receives: Device: Titania® Cervical Disc Prosthesis (PEEK)
Lumbar Interbody Fusion Cages (Titanium)		Subjects undergoing surgery with "Titania® Lumbar Interbody Fusion Cages (Titanium)" will be followed for 12 months. Receives: Device: Titania® Lumbar Interbody Fusion Cages (Titanium)
Lumbar Interbody Fusion Cages (PEEK)		Subjects undergoing surgery with "Titania® Lumbar Interbody Fusion Cages (PEEK)" will be followed for 12 months. Receives: Device: Titania® Lumbar Interbody Fusion Cages (PEEK)
Interspinous Fusion Device (Titanium)		Subjects undergoing surgery with "Titania® Interspinous Fusion Device (Titanium)" will be followed for 12 months. Receives: Device: Titania® Interspinous Fusion Device (Titanium)
Posterior Thoracolumbar Stabilization Systems		Subjects undergoing surgery with "Titania® Posterior Thoracolumbar Stabilization Systems" will be followed for 12 months. Receives: Device: Titania® Posterior Thoracolumbar Stabilization Systems
Posterior Thoracolumbar Clamp Systems		Subjects undergoing surgery with "Titania® Posterior Thoracolumbar Clamp Systems" will be followed for 12 months. Receives: Device: Titania® Posterior Thoracolumbar Clamp Systems
Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)		Subjects undergoing surgery with "Titania® Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)" will be followed for 12 months. Receives: Device: Titania® Thoracolumbar Dynamic Stabilization System (Elastic Rod)
Synthetic Bone Grafts (Cervical Application)		Subjects undergoing surgery with "Bonegraft® Synthetic Bone Grafts" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., NDI scores) in the cervical region. Receives: Device: Bonegraft® Synthetic Bone Grafts
Synthetic Bone Grafts (Thoracolumbar Application)		Subjects undergoing surgery with "Bonegraft® Synthetic Bone Grafts" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region. Receives: Device: Bonegraft® Synthetic Bone Grafts
Bone Cement (Cervical Application)		Subjects undergoing surgery with "Bonegraft® Synthetic Bone Cement" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the cervical region. Receives: Device: Bonegraft® Bone Cement
Bone Cement (Thoracolumbar Application)		Subjects undergoing surgery with "Bonegraft® Synthetic Bone Cement" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region. Receives: Device: Bonegraft® Bone Cement

Arm	Type	Receives
Cervical Interbody Fusion Cages (Titanium)	–	Device: Titania® Cervical Interbody Fusion Cage (Titanium)Subjects undergoing surgery with "Titania® Cervical Interbody Fusion Cages (Titanium)" will be followed for 12 months.
Cervical Interbody Fusion Cages (PEEK)	–	Device: Titania® Cervical Interbody Fusion Cage (PEEK)Subjects undergoing surgery with "Titania® Cervical Interbody Fusion Cages (PEEK)" will be followed for 12 months.
Posterior Cervical Stabilization Systems	–	Device: Titania® Posterior Cervical Stabilization SystemSubjects undergoing surgery with "Titania® Posterior Cervical Stabilization Systems" will be followed for 12 months.
Cervical Plate Systems	–	Device: Titania® Cervical Plate SystemSubjects undergoing surgery with "Titania® Cervical Plate System" will be followed for 12 months.
Cervical Dynamic Stabilization Systems (Elastic Rod)	–	Device: Titania® Cervical Dynamic Stabilization System (Elastic Rod)Subjects undergoing surgery with "Titania® Cervical Dynamic Stabilization Systems (Elastic Rod)" will be followed for 12 months.
Cervical Disc Prosthesis (Titanium)	–	Device: Titania® Cervical Disc Prosthesis (Titanium)Subjects undergoing surgery with "Titania® Cervical Disc Prosthesis (Titanium)" will be followed for 12 months.
Cervical Disc Prosthesis (PEEK)	–	Device: Titania® Cervical Disc Prosthesis (PEEK)Subjects undergoing surgery with "Titania® Cervical Disc Prosthesis (PEEK)" will be followed for 12 months.
Lumbar Interbody Fusion Cages (Titanium)	–	Device: Titania® Lumbar Interbody Fusion Cages (Titanium)Subjects undergoing surgery with "Titania® Lumbar Interbody Fusion Cages (Titanium)" will be followed for 12 months.
Lumbar Interbody Fusion Cages (PEEK)	–	Device: Titania® Lumbar Interbody Fusion Cages (PEEK)Subjects undergoing surgery with "Titania® Lumbar Interbody Fusion Cages (PEEK)" will be followed for 12 months.
Interspinous Fusion Device (Titanium)	–	Device: Titania® Interspinous Fusion Device (Titanium)Subjects undergoing surgery with "Titania® Interspinous Fusion Device (Titanium)" will be followed for 12 months.
Posterior Thoracolumbar Stabilization Systems	–	Device: Titania® Posterior Thoracolumbar Stabilization SystemsSubjects undergoing surgery with "Titania® Posterior Thoracolumbar Stabilization Systems" will be followed for 12 months.
Posterior Thoracolumbar Clamp Systems	–	Device: Titania® Posterior Thoracolumbar Clamp SystemsSubjects undergoing surgery with "Titania® Posterior Thoracolumbar Clamp Systems" will be followed for 12 months.
Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)	–	Device: Titania® Thoracolumbar Dynamic Stabilization System (Elastic Rod)Subjects undergoing surgery with "Titania® Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)" will be followed for 12 months.
Synthetic Bone Grafts (Cervical Application)	–	Device: Bonegraft® Synthetic Bone GraftsSubjects undergoing surgery with "Bonegraft® Synthetic Bone Grafts" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., NDI scores) in the cervical region.
Synthetic Bone Grafts (Thoracolumbar Application)	–	Device: Bonegraft® Synthetic Bone GraftsSubjects undergoing surgery with "Bonegraft® Synthetic Bone Grafts" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region.
Bone Cement (Cervical Application)	–	Device: Bonegraft® Bone CementSubjects undergoing surgery with "Bonegraft® Synthetic Bone Cement" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the cervical region.
Bone Cement (Thoracolumbar Application)	–	Device: Bonegraft® Bone CementSubjects undergoing surgery with "Bonegraft® Synthetic Bone Cement" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region.