Degenerative InstabilityNCT06265038
Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
A study testing ReSpace TiCell Cage in people with Degenerative Instability and Spondylolisthesis, run by Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. at 1 site in Hungary.
Trial summary
The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome
- What is being tested?
- ReSpace TiCell Cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteHungary
- Study dates
- 1 Feb 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each subject must meet all the following criteria to be enrolled in this study:
- All subjects who had previously indicated for TLIF surgery can participate in this study, with the following evidence:
- Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L1 to S1), manifested by:
- Low back pain, or
- Irradiating leg or buttock pain, paresthesia, numbness, or weakness, or
- History of neurogenic claudication.
Show all 18Show fewer
- Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:
- Instability as defined by ≥3 mm translation or ≥5-degree angulation
- Decreased disc height, on average by ≥2 mm, but dependent upon the spinal level
- Scarring/thickening of ligamentum flavum or annulus fibrosis
- Herniated nucleus pulposus
- Vacuum phenomenon
- Grade 1 spondylolisthesis/retrolisthesis based on the Meyerding classification (Meyerding, Henry William, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal to 3mm, or
- Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or
- Recurrent disc herniation
- Further inclusion criteria:
- Skeletally mature adults ages 18 - 80 years of age
- Able to read and understand all documents used in this study, including the informed consent and patient-reported outcome questionnaires
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Prior surgical procedure at the involved or adjacent spinal levels (e.g. stabilization, fusion, arthroplasty and/or other non-fusion procedures). Prior microdiscectomy, discectomy, laminectomy, decompression surgery at the target or adjacent levels is allowed.
- Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
- Planned use of an internal or external bone growth stimulator.
- Lumbar scoliosis >30 degrees.
- Patients who had a previous diagnosis of osteoporosis with a Tscore of -2.5 or below in the last 12 months. If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA (dual x-ray absorptiometry) scan will need to be obtained.
Show all 24Show fewer
- Morbidly obese, as defined by a Body Mass Index (BMI) >40.
- Presence of active malignancy or prior history of malignancy (noninvasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to the skin is allowed).
- Overt or active bacterial infection, either local to surgical space or systemic.
- Has undergone administration of any type of corticosteroid, antineoplastic, immunostimulant, or immunosuppressive agents, or medications known to inhibit with the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment
- This includes patients ≥ 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment
- Use of steroidal inhalers, short-term NSAID use, and shortterm steroidal use (e.g. Medrol Dosepak) is allowed pre and postoperatively. For this clinical study, short-term use is defined as ≤ two weeks.
- Use of NSAIDs and/or steroids for longer than two weeks postoperatively through the 24 Month Follow-Up Visit is not recommended. Such patients must be excluded from data analysis in case of non-fusion.
- Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
- Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
- Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).
- Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g.: monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome, cobalt chrome alloy, or PEEK).
- History of any allergy resulting in anaphylaxis.
- Is mentally incompetent. If questionable, obtain psychiatric consult.
- Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
- Pregnancy and breastfeeding.
- A documented diagnosis of substance use disorder (Nicotine use is allowed.)
- Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data interpretation.
- Subject is considered to belong to a vulnerable population.
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
National Center for Spinal Disorders
Budapest, Pest County, 1126
Aron Lazary, MD, PhD, +36118877900 ext. 5671, lazary.aron@gmail.com
About this study
Official title: A Prospective, Single Center, Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in Transforaminal Lumbar Interbody Fusion
The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.
The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:
- To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain.
- To evaluate if implantation causes significant increase quality of life of the patients.
- To evaluate if using the device can be considered as safe overall.
Read the detailed description
Degenerative disc and facet joint disease of the lumbar spine is common in the ageing population and is one of the most frequent causes of disability. Lumbar spondylosis may result in mechanical back pain, radicular and claudicant symptoms, reduced mobility and poor quality of life. Surgical interbody fusion of degenerative levels is an effective treatment option to stabilize the painful motion segment, and may provide indirect decompression of the neural elements, restore lordosis and correct deformity. Lumbar interbody fusion (LIF) involves placement of an implant (cage, spacer or structural graft) within the intervertebral space after discectomy and endplate preparation. At this time LIF is performed using five main approaches; posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), oblique lumbar interbody fusion/anterior to psoas (OLIF/ATP), anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). There is no clear definitive evidence for one approach being superior to another in terms of fusion or clinical outcomes. These operations can also be performed using mini-open or minimally invasive (MIS) approaches, however it has not yet been demonstrated that MIS-TLIF is clinically superior to traditional open TLIF procedure. Interbody fusion is preferable to postero-lateral 'onlay' fusion techniques due to lower rates of postoperative complications and pseudoarthrosis.
Posterior interbody fusion (PLIF), combined with segmental instrumentation, has become increasingly popular since it was first described by Mercer in 1936 and expanded upon by Cloward. More recently however, the transforaminal approach to the intervertebral disc, known as transforaminal lumbar interbody fusion (TLIF), has gained popularity. Originally described by Harms in the late 1990s, the TLIF has arguably developed into the most commonly performed and efficacious posterior interbody fusion method in modern spine surgery.
Transforaminal lumbar interbody fusion (TLIF) utilizes a more lateral window in order to access the interbody space without excessive dural retraction. Theoretical advantages of TLIF include increased fusion success, more complete foraminal decompression, better correction of deformity, and more effective treatment of discogenic pain.
Transforaminal lumbar interbody fusion (TLIF) have demonstrated excellent fusion rates with acceptable complication profiles for treating single and multilevel lumbar disc pathology and instability. TLIF have been shown to be superior to posterolateral fusion alone for deformity correction and more cost effective than anterior interbody combined with posterior segmental instrumentation.
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instability
- Being tested
- ReSpace TiCell Cage
- Keywords
- lumbar spinal, interbody fusion, interbody cage, 3D printing
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReSpace TiCell CageDevice
ReSpace TiCell Cages are anatomically shaped interbody spacer implants with curved contour. These implants intended to be inserted into the intervertebral disc space for intervertebral body fusion. The interbody spacers are designed to restore height and lordotic angle in the spine. The spacers have teeth on the endplate-engaging surfaces to provide stability, resist shear and rotational forces, and to help prevent migration of the spacer within the disc space. The open central cavity on them allows for placement of graft material allowing for subsequent bone growth through the interior of the devices.
ReSpace TiCell Cages are indicated for lumbar spine stabilization (between L.I.-S.I. segments). TLIF spine surgery will be combined with posterior fixation using pedicle screws and rods.
| Study group | Role | What they receive |
|---|---|---|
| Prospective, single-arm, open-label clinical trial. | Other | Single center, prospective cohort, single-arm, open-label clinical trial Standard-of-care \& Sanatmetal ReSpace TiCell Cage implantation A single-center study is sufficient to provide confirmatory data on performance and safety of the investigational device. Receives: Device: ReSpace TiCell Cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT imaging_1 - cumulative fusion rate
For the determination of the cumulative fusion rate, radiographic evaluation (CT imaging with fine-cut axial and multiplanar reconstruction views) will be conducted by 2 independent examiners.
Measured: At visit 4 (Month 24)
CT imaging_2 - fusion status
Standing flexion-extension angle will be measured with dynamic plain radiography to evaluate mobility to determine the fusion status.
Measured: At visit 4 (Month 24)
Secondary outcomes (2)
Visual Analog Scale
The severity of back, hip/buttock, and leg pain will each be evaluated in all study subjects using a 100-mm Visual Analog Scale (VAS). Minimum value is 0mm, maximum value is 100mm. The low value means low intensity of the pain, which is the aim of the treatment.
Measured: At visits 1/2/3/4 (Months 3/6/12 and 24)
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) is a validated, independent outcome measure. It is one of the principal condition-specific outcome measures used in the management of spinal disorders and in patients with low back pain. The questionnaire contains 10 questions. There are 6 possible answers available to each questions. The 1. answer means each time the lowest pain, which is the aim of the treatment. At the end the doctor calculate a rate of the patient pain in %.
Measured: At visits 1/2/3/4 (Months 3/6/12 and 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Degenerative InstabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, open-label clinical trial. This clinical investigation addresses to collect data on clinical performance, effectiveness and safety of Sanatmetál's ReSpace TiCell Cage in human subjects following the good clinical practice according to the Medical Device Regulation (MDR) \& EN ISO 14155:2020. The study is conducted in Hungary at National Center for Spinal Disorders.
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aron Lazary, MD, PhD, Principal investigator, National Center for Spinal Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265038
- Sponsor's protocol ID
- SANAT-CAGE-2022
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ajiboye RM, Alas H, Mosich GM, Sharma A, Pourtaheri S. Radiographic and Clinical Outcomes of Anterior and Transforaminal Lumbar Interbody Fusions: A Systematic Review and Meta-analysis of Comparative Studies. Clin Spine Surg. 2018 May;31(4):E230-E238. doi: 10.1097/BSD.0000000000000549.
PubMed 28622187Kim JS, Kang BU, Lee SH, Jung B, Choi YG, Jeon SH, Lee HY. Mini-transforaminal lumbar interbody fusion versus anterior lumbar interbody fusion augmented by percutaneous pedicle screw fixation: a comparison of surgical outcomes in adult low-grade isthmic spondylolisthesis. J Spinal Disord Tech. 2009 Apr;22(2):114-21. doi: 10.1097/BSD.0b013e318169bff5.
PubMed 19342933Kim JS, Lee KY, Lee SH, Lee HY. Which lumbar interbody fusion technique is better in terms of level for the treatment of unstable isthmic spondylolisthesis? J Neurosurg Spine. 2010 Feb;12(2):171-7. doi: 10.3171/2009.9.SPINE09272.
PubMed 20121352Crandall DG, Revella J. Transforaminal lumbar interbody fusion versus anterior lumbar interbody fusion as an adjunct to posterior instrumented correction of degenerative lumbar scoliosis: three year clinical and radiographic outcomes. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2126-33. doi: 10.1097/BRS.0b013e3181b612db.
PubMed 19752698Dorward IG, Lenke LG, Bridwell KH, O'Leary PT, Stoker GE, Pahys JM, Kang MM, Sides BA, Koester LA. Transforaminal versus anterior lumbar interbody fusion in long deformity constructs: a matched cohort analysis. Spine (Phila Pa 1976). 2013 May 20;38(12):E755-62. doi: 10.1097/BRS.0b013e31828d6ca3.
PubMed 23442780Faundez AA, Schwender JD, Safriel Y, Gilbert TJ, Mehbod AA, Denis F, Transfeldt EE, Wroblewski JM. Clinical and radiological outcome of anterior-posterior fusion versus transforaminal lumbar interbody fusion for symptomatic disc degeneration: a retrospective comparative study of 133 patients. Eur Spine J. 2009 Feb;18(2):203-11. doi: 10.1007/s00586-008-0845-0. Epub 2009 Jan 6.
PubMed 19125304Hee HT, Castro FP Jr, Majd ME, Holt RT, Myers L. Anterior/posterior lumbar fusion versus transforaminal lumbar interbody fusion: analysis of complications and predictive factors. J Spinal Disord. 2001 Dec;14(6):533-40. doi: 10.1097/00002517-200112000-00013.
PubMed 11723406Levin JM, Tanenbaum JE, Steinmetz MP, Mroz TE, Overley SC. Posterolateral fusion (PLF) versus transforaminal lumbar interbody fusion (TLIF) for spondylolisthesis: a systematic review and meta-analysis. Spine J. 2018 Jun;18(6):1088-1098. doi: 10.1016/j.spinee.2018.01.028. Epub 2018 Feb 13.
PubMed 29452283Carreon LY, Glassman SD, Ghogawala Z, Mummaneni PV, McGirt MJ, Asher AL. Modeled cost-effectiveness of transforaminal lumbar interbody fusion compared with posterolateral fusion for spondylolisthesis using N(2)QOD data. J Neurosurg Spine. 2016 Jun;24(6):916-21. doi: 10.3171/2015.10.SPINE15917. Epub 2016 Feb 19.
PubMed 26895529Fujimori T, Le H, Schairer WW, Berven SH, Qamirani E, Hu SS. Does Transforaminal Lumbar Interbody Fusion Have Advantages over Posterolateral Lumbar Fusion for Degenerative Spondylolisthesis? Global Spine J. 2015 Apr;5(2):102-9. doi: 10.1055/s-0034-1396432. Epub 2014 Dec 1.
PubMed 25844282Ghasemi AA. Transforaminal lumbar interbody fusion versus instrumented posterolateral fusion In degenerative spondylolisthesis: An attempt to evaluate the superiority of one method over the other. Clin Neurol Neurosurg. 2016 Nov;150:1-5. doi: 10.1016/j.clineuro.2016.08.017. Epub 2016 Aug 21.
PubMed 27565009Owens RK 2nd, Carreon LY, Djurasovic M, Glassman SD. Relative benefit of TLIF versus PSF stratified by diagnostic indication. J Spinal Disord Tech. 2014 May;27(3):144-7. doi: 10.1097/BSD.0b013e3182867470.
PubMed 24945292Pooswamy S, Muralidharagopalan NR, Subbaiah S. Transforaminal lumbar interbody fusion versus instrumented posterolateral fusion in Grade I/II spondylolisthesis. Indian J Orthop. 2017 Mar-Apr;51(2):131-138. doi: 10.4103/0019-5413.201703.
PubMed 28400657Makanji H, Schoenfeld AJ, Bhalla A, Bono CM. Critical analysis of trends in lumbar fusion for degenerative disorders revisited: influence of technique on fusion rate and clinical outcomes. Eur Spine J. 2018 Aug;27(8):1868-1876. doi: 10.1007/s00586-018-5544-x. Epub 2018 Mar 15.
PubMed 29546538
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in Transforaminal Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT06265038
- Acronym / sponsor ID
- SANAT-CAGE-2022
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instability
- Keywords
- lumbar spinal, interbody fusion, interbody cage, 3D printing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 20 Feb 2024 (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.
The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.
The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:
- To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain.
- To evaluate if implantation causes significant increase quality of life of the patients.
- To evaluate if using the device can be considered as safe overall.
Detailed description
Degenerative disc and facet joint disease of the lumbar spine is common in the ageing population and is one of the most frequent causes of disability. Lumbar spondylosis may result in mechanical back pain, radicular and claudicant symptoms, reduced mobility and poor quality of life. Surgical interbody fusion of degenerative levels is an effective treatment option to stabilize the painful motion segment, and may provide indirect decompression of the neural elements, restore lordosis and correct deformity. Lumbar interbody fusion (LIF) involves placement of an implant (cage, spacer or structural graft) within the intervertebral space after discectomy and endplate preparation. At this time LIF is performed using five main approaches; posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), oblique lumbar interbody fusion/anterior to psoas (OLIF/ATP), anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). There is no clear definitive evidence for one approach being superior to another in terms of fusion or clinical outcomes. These operations can also be performed using mini-open or minimally invasive (MIS) approaches, however it has not yet been demonstrated that MIS-TLIF is clinically superior to traditional open TLIF procedure. Interbody fusion is preferable to postero-lateral 'onlay' fusion techniques due to lower rates of postoperative complications and pseudoarthrosis.
Posterior interbody fusion (PLIF), combined with segmental instrumentation, has become increasingly popular since it was first described by Mercer in 1936 and expanded upon by Cloward. More recently however, the transforaminal approach to the intervertebral disc, known as transforaminal lumbar interbody fusion (TLIF), has gained popularity. Originally described by Harms in the late 1990s, the TLIF has arguably developed into the most commonly performed and efficacious posterior interbody fusion method in modern spine surgery.
Transforaminal lumbar interbody fusion (TLIF) utilizes a more lateral window in order to access the interbody space without excessive dural retraction. Theoretical advantages of TLIF include increased fusion success, more complete foraminal decompression, better correction of deformity, and more effective treatment of discogenic pain.
Transforaminal lumbar interbody fusion (TLIF) have demonstrated excellent fusion rates with acceptable complication profiles for treating single and multilevel lumbar disc pathology and instability. TLIF have been shown to be superior to posterolateral fusion alone for deformity correction and more cost effective than anterior interbody combined with posterior segmental instrumentation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, open-label clinical trial. This clinical investigation addresses to collect data on clinical performance, effectiveness and safety of Sanatmetál's ReSpace TiCell Cage in human subjects following the good clinical practice according to the Medical Device Regulation (MDR) \& EN ISO 14155:2020. The study is conducted in Hungary at National Center for Spinal Disorders.
| Arm | Type | Receives |
|---|---|---|
| Prospective, single-arm, open-label clinical trial. | Other | Device: ReSpace TiCell CageSingle center, prospective cohort, single-arm, open-label clinical trial Standard-of-care \& Sanatmetal ReSpace TiCell Cage implantation A single-center study is sufficient to provide confirmatory data on performance and safety of the investigational device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- All subjects who had previously indicated for TLIF surgery can participate in this study, with the following evidence:
- Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L1 to S1), manifested by:
- Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:
- Skeletally mature adults ages 18 - 80 years of age
- Able to read and understand all documents used in this study, including the informed consent and patient-reported outcome questionnaires
Key exclusion criteria (24 listed)
- Prior surgical procedure at the involved or adjacent spinal levels (e.g. stabilization, fusion, arthroplasty and/or other non-fusion procedures). Prior microdiscectomy, discectomy, laminectomy, decompression surgery at the target or adjacent levels is allowed.
- Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater than 3 mm at any involved level.
- Planned use of an internal or external bone growth stimulator.
- Lumbar scoliosis >30 degrees.
- Patients who had a previous diagnosis of osteoporosis with a Tscore of -2.5 or below in the last 12 months. If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA (dual x-ray absorptiometry) scan will need to be obtained.
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 |
|---|---|---|
| ReSpace TiCell CageReSpace TiCell Cages are anatomically shaped interbody spacer implants with curved contour. These implants intended to be inserted into the intervertebral disc space for intervertebral body fusion. The interbody spacers are designed to restore height and lordotic angle in the spine. The spacers have teeth on the endplate-engaging surfaces to provide stability, resist shear and rotational forces, and to help prevent migration of the spacer within the disc space. The open central cavity on them allows for placement of graft material allowing for subsequent bone growth through the interior of the devices. ReSpace TiCell Cages are indicated for lumbar spine stabilization (between L.I.-S.I. segments). TLIF spine surgery will be combined with posterior fixation using pedicle screws and rods. | Device | Prospective, single-arm, open-label clinical trial. |
Primary outcome
CT imaging_1 - cumulative fusion rate
Time frame: At visit 4 (Month 24)
For the determination of the cumulative fusion rate, radiographic evaluation (CT imaging with fine-cut axial and multiplanar reconstruction views) will be conducted by 2 independent examiners.
CT imaging_2 - fusion status
Time frame: At visit 4 (Month 24)
Standing flexion-extension angle will be measured with dynamic plain radiography to evaluate mobility to determine the fusion status.
2 secondary outcomes
Visual Analog Scale
Time frame: At visits 1/2/3/4 (Months 3/6/12 and 24)
Oswestry Disability Index (ODI)
Time frame: At visits 1/2/3/4 (Months 3/6/12 and 24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Results publication: PubMed 28622187Ajiboye RM, Alas H, Mosich GM, Sharma A, Pourtaheri S. Radiographic and Clinical Outcomes of Anterior and Transforaminal Lumbar Interbody Fusions: A Systematic Review and Meta-analysis of Comparative Studies. Clin Spine Surg. 2018 May;31(4):E230-E238. doi: 10.1097/BSD.0000000000000549.
- Results publication: PubMed 19342933Kim JS, Kang BU, Lee SH, Jung B, Choi YG, Jeon SH, Lee HY. Mini-transforaminal lumbar interbody fusion versus anterior lumbar interbody fusion augmented by percutaneous pedicle screw fixation: a comparison of surgical outcomes in adult low-grade isthmic spondylolisthesis. J Spinal Disord Tech. 2009 Apr;22(2):114-21. doi: 10.1097/BSD.0b013e318169bff5.
- Results publication: PubMed 20121352Kim JS, Lee KY, Lee SH, Lee HY. Which lumbar interbody fusion technique is better in terms of level for the treatment of unstable isthmic spondylolisthesis? J Neurosurg Spine. 2010 Feb;12(2):171-7. doi: 10.3171/2009.9.SPINE09272.
- Results publication: PubMed 19752698Crandall DG, Revella J. Transforaminal lumbar interbody fusion versus anterior lumbar interbody fusion as an adjunct to posterior instrumented correction of degenerative lumbar scoliosis: three year clinical and radiographic outcomes. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2126-33. doi: 10.1097/BRS.0b013e3181b612db.
- Results publication: PubMed 23442780Dorward IG, Lenke LG, Bridwell KH, O'Leary PT, Stoker GE, Pahys JM, Kang MM, Sides BA, Koester LA. Transforaminal versus anterior lumbar interbody fusion in long deformity constructs: a matched cohort analysis. Spine (Phila Pa 1976). 2013 May 20;38(12):E755-62. doi: 10.1097/BRS.0b013e31828d6ca3.
- Results publication: PubMed 19125304Faundez AA, Schwender JD, Safriel Y, Gilbert TJ, Mehbod AA, Denis F, Transfeldt EE, Wroblewski JM. Clinical and radiological outcome of anterior-posterior fusion versus transforaminal lumbar interbody fusion for symptomatic disc degeneration: a retrospective comparative study of 133 patients. Eur Spine J. 2009 Feb;18(2):203-11. doi: 10.1007/s00586-008-0845-0. Epub 2009 Jan 6.
- Results publication: PubMed 11723406Hee HT, Castro FP Jr, Majd ME, Holt RT, Myers L. Anterior/posterior lumbar fusion versus transforaminal lumbar interbody fusion: analysis of complications and predictive factors. J Spinal Disord. 2001 Dec;14(6):533-40. doi: 10.1097/00002517-200112000-00013.
- Results publication: PubMed 29452283Levin JM, Tanenbaum JE, Steinmetz MP, Mroz TE, Overley SC. Posterolateral fusion (PLF) versus transforaminal lumbar interbody fusion (TLIF) for spondylolisthesis: a systematic review and meta-analysis. Spine J. 2018 Jun;18(6):1088-1098. doi: 10.1016/j.spinee.2018.01.028. Epub 2018 Feb 13.
- Results publication: PubMed 26895529Carreon LY, Glassman SD, Ghogawala Z, Mummaneni PV, McGirt MJ, Asher AL. Modeled cost-effectiveness of transforaminal lumbar interbody fusion compared with posterolateral fusion for spondylolisthesis using N(2)QOD data. J Neurosurg Spine. 2016 Jun;24(6):916-21. doi: 10.3171/2015.10.SPINE15917. Epub 2016 Feb 19.
- Results publication: PubMed 25844282Fujimori T, Le H, Schairer WW, Berven SH, Qamirani E, Hu SS. Does Transforaminal Lumbar Interbody Fusion Have Advantages over Posterolateral Lumbar Fusion for Degenerative Spondylolisthesis? Global Spine J. 2015 Apr;5(2):102-9. doi: 10.1055/s-0034-1396432. Epub 2014 Dec 1.
- Results publication: PubMed 27565009Ghasemi AA. Transforaminal lumbar interbody fusion versus instrumented posterolateral fusion In degenerative spondylolisthesis: An attempt to evaluate the superiority of one method over the other. Clin Neurol Neurosurg. 2016 Nov;150:1-5. doi: 10.1016/j.clineuro.2016.08.017. Epub 2016 Aug 21.
- Results publication: PubMed 24945292Owens RK 2nd, Carreon LY, Djurasovic M, Glassman SD. Relative benefit of TLIF versus PSF stratified by diagnostic indication. J Spinal Disord Tech. 2014 May;27(3):144-7. doi: 10.1097/BSD.0b013e3182867470.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aron Lazary, MD, PhD principal investigator
National Center for Spinal Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReSpace TiCell Cage in people with Degenerative Instability and Spondylolisthesis, run by Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. at 1 site in Hungary.
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 18 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bálint Kozma (+3630 6861784, bkozma@sanatmetal.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT imaging_1 - cumulative fusion rate (time frame: At visit 4 (Month 24)). The study lists 2 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 NCT06265038, which also lists 14 linked publications.
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 21 Feb 2024.