Degenerative Disc Disease in Cervical SpineNCT07834749
PMCF Study Fortilink-SC
An observational study of Degenerative Disc Disease in Cervical Spine and Stenosis Cervical Spine, run by BAAT Medical Products B.V. at 2 sites in Spain.
Trial summary
This study is setup to be able to gather information on the safety and performance of the Fortilink-SC Ti cage of Paradigm Spine GmbH, up to one year after the surgery. The device is intended to be used in intervertebral fusion surgery. Around 50 participants will participate in this study in 2 hospitals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine
- What is being tested?
- Cervical interbody fusion surgery (standalone)
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients matching the indications for the device, treated in the clinical selected for participation in the study
Who may be able to join
- Willing and able to five voluntary informed consent
- Skeletally mature patient
- At least 6 weeks of nonoperative treatment
- Degenerative disc disease (DDD) of the cervical spine at one or two contiguous levels between C2 and T1, with DDD being defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spinal stenosis
Who cannot join
- Active systematic infection or an active infection at the operative site
- A demonstrated allergy or sensitivity to any of the implanted materials
- Severe osteoporosis (confirmed by imaging in the patient's medical history or during screening)
- Primary or metastatic tumours affecting the spine (confirmed by imaging in the patient's medical history or during screening)
- Conditions that may place excessive stresses on the bones and the implants, including but not limited to morbid obesity or other degenerative diseases, , at the discretion of the investigator
- Patients whose ability to follow postoperative restrictions, precautions and rehabilitation programs is limited
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- Fractures, severe deformities or a severe instability in the area of surgery (confirmed by imaging in the patient's medical history or during screening)
- A medical or surgical situation that would preclude the benefit of surgery
- Pregnancy
- Patient's denial for operative treatment, post-operative rehabilitation program, follow up appointments and/or participation in the trial
- Protocol specified surgical technique cannot be followed for the subject
- Any other reason (in the judgment of the investigator).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Vithas de la Milagrosa
Madrid, Madrid, 28010
Principal Investigator, +34 91 447 21 00, secretaria.lamilagrosa@vithas.es
- Recruiting
Hospital Universitario Vithas Madrid Aravaca
Moncloa-Aravaca, Madrid, 28023
Principal Investigator, +34 915 12 90 00, InfoAravaca@Vithas.es
About this study
Official title: Post-market Clinical Study of the Fortilink-SC Ti
This study is setup to be able to gather information on the safety and performance of the Fortilink-SC Ti cage of Paradigm Spine GmbH, up to one year after the surgery. The device is intended to be used in intervertebral fusion surgery. Around 50 participants will participate in this study in 2 hospitals. The Fortilink-SC Ti cage is meant to be placed in the neck, to treat degenerative disc disease and/or stenosis. The study will involve data gathering based on routine care. The study will only entail collection of data (medical history prior to the surgery, data from the surgery and data in the follow up after one year). Fortilink-SC Ti cages are not new, but have been on the market since 2020. The clinical study is performed to actively gather data on the use of this product in the intended group of patients, to monitor its safety and performance. The treatment and follow-up provided in this study does not differ from the standard of care; meaning that participants in the study will receive the same treatment and follow the same follow-up visits and assessments as patients undergoing the same procedure outside of the study.
Read the detailed description
This study is setup to be able to gather information on the safety and performance of the Fortilink-SC Ti cage of Paradigm Spine GmbH, up to one year after the surgery. The device is intended to be used in intervertebral fusion surgery. Around 50 participants will participate in this study in 2 hospitals. The Fortilink-SC Ti cage is meant to be placed in the neck, to treat degenerative disc disease and/or stenosis. The study will involve data gathering based on routine care. The study will only entail collection of data (medical history prior to the surgery, data from the surgery and data in the follow up after one year). Fortilink-SC Ti cages are not new, but have been on the market since 2020. The clinical study is performed to actively gather data on the use of this product in the intended group of patients, to monitor its safety and performance. The treatment and follow-up provided in this study does not differ from the standard of care; meaning that participants in the study will receive the same treatment and follow the same follow-up visits and assessments as patients undergoing the same procedure outside of the study.
- Being tested
- Cervical interbody fusion surgery (standalone)
- Keywords
- Anterior cervical interbody fusion, ACIF, standalone ACIF, degenerative disc disease, cervical stenosis, PMCF
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical interbody fusion surgery (standalone)Procedure or surgery
Fortilink-SC
| Study group | Role | What they receive |
|---|---|---|
| Fortilink-SC - treated patients | Not described Receives: Procedure: Cervical interbody fusion surgery (standalone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NDI score at 12 months follow-up
Change between baseline and 12 months follow-up
Measured: Improvement in NDI score at 12 months over baseline
Secondary outcomes (4)
Change in VAS neck and arm pain scores
Measured: Baseline to 12 months post-surgery
Incidence of complications and adverse events
Measured: Up to 12 months post-surgery
Incidence of imaging-confirmed complications
Imaging confirmed complications, such as subsidence, implant migration, or implant failure/breakage, identified during routine follow-up
Measured: During follow-up through 12 months post-surgery
Radiographic fusion status
Fusion status based on imaging performed during routine follow-up
Measured: During follow-up through 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 in Cervical SpineStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BAAT Medical Products B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paradigm Spine, Archer Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834749
- Sponsor's protocol ID
- FORTILINK_SA-CIF_2025
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided