NCT07834736Recruiting
PMCF Study Fortilink-TS Ti
Post-market Clinical Study of the Fortilink-TS Ti
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
This study is setup to be able to gather information on the safety and performance of the Fortilink-TS 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-TS Ti cage is meant to be placed in the lower back, to treat degenerative disc disease with up to grade I spondylolisthesis. 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-TS 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 8 Jul 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- BAAT Medical Products B.V.
- NCT number
- NCT07834736
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Jan 2026 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Protocol specified surgical technique cannot be followed for the subject
Other illness
- Active systematic infection or an active infection at the operative site
- A demonstrated allergy or sensitivity to any of the implanted materials
- 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
Other
- 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)
- Patients whose ability to follow postoperative restrictions, precautions and rehabilitation programs is limited
- Pregnancy
- Patient's denial for operative treatment, post-operative rehabilitation program, follow up appointments and/or participation in the trial
- Any other reason (in the judgment of the investigator).
Who the study is looking for
- Willing and able to give voluntary informed consent
- Skeletally mature patients
- At least 6 months of non-operative treatment
- Degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels between L2 and S1, with DDD being defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, and/or up to grade 1 spondylolisthesis of the lumbar spine at one or two contiguous levels between L2 and S1
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Santa Elena Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Centro Médico Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.