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RecruitingNCT07834749Updated Sep 22, 2026

PMCF Study Fortilink-SC

An observational study in Degenerative Disc Disease in Cervical Spine and Stenosis Cervical Spine, sponsored by BAAT Medical Products B.V.. Recruiting at 2 sites in Spain. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by BAAT Medical Products B.V. · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Degenerative Disc Disease in Cervical Spine
  • Stenosis Cervical Spine

Keywords

  • Anterior cervical interbody fusion
  • ACIF
  • standalone ACIF
  • degenerative disc disease
  • cervical stenosis
  • PMCF
03

In context

Intervertebral Disc Degeneration

462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.

This study's planned enrollment of 50 is below the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

BAAT Medical Products B.V. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Browse BAAT Medical Products B.V. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients matching the indications for the device, treated in the clinical selected for participation in the study

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Willing and able to five voluntary
  2. Skeletally mature patient
  3. At least 6 weeks of nonoperative treatment
  4. 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
  5. Spinal stenosis

Exclusion criteria

Exclusion Criteria:

  1. Active systematic infection or an active infection at the operative site
  2. A demonstrated allergy or sensitivity to any of the implanted materials
  3. Severe osteoporosis (confirmed by imaging in the patient's medical history or during screening)
  4. Primary or tumours affecting the spine (confirmed by imaging in the patient's medical history or during screening)
  5. 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
  6. Patients whose ability to follow postoperative restrictions, precautions and rehabilitation programs is limited
  7. Fractures, severe deformities or a severe instability in the area of surgery (confirmed by imaging in the patient's medical history or during screening)
  8. A medical or surgical situation that would preclude the benefit of surgery
  9. Pregnancy
  10. Patient's denial for operative treatment, post-operative rehabilitation program, follow up appointments and/or participation in the trial
  11. Protocol specified surgical technique cannot be followed for the subject
  12. Any other reason (in the judgment of the investigator).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fortilink-SC - treated patients

    Procedure: Cervical interbody fusion surgery (standalone)

Interventions

  • ProcedureCervical interbody fusion surgery (standalone)

    Fortilink-SC

06

What researchers measure

Primary outcomes

  1. Change in NDI score at 12 months follow-up

    Change between baseline and 12 months follow-up

    Time frame: Improvement in NDI score at 12 months over baseline

Secondary outcomes

  1. Change in VAS neck and arm pain scores

    Time frame: Baseline to 12 months post-surgery

  2. Incidence of complications and adverse events

    Time frame: Up to 12 months post-surgery

  3. Incidence of imaging-confirmed complications

    Imaging confirmed complications, such as subsidence, implant migration, or implant failure/breakage, identified during routine follow-up

    Time frame: During follow-up through 12 months post-surgery

  4. Radiographic fusion status

    Fusion status based on imaging performed during routine follow-up

    Time frame: During follow-up through 12 months post-surgery

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.

Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's planned 23 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2025
First posted
Sep 22, 2026
StartActual
Jan 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07834749
Lead sponsor
BAAT Medical Products B.V.
Collaborators
Paradigm Spine, Archer Research
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Jan 1, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Tess Jimenez - van Dam, MSc
Contact
tess@baatmedical.com
+31 - (0)6 - 267 18 663

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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