Ireland
--:--IST
Recruiting Observational

PMCF Study Fortilink-SC

NCT07834749 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2026-01-01
Last updated
2026-09-22

Condition(s) studied

Degenerative Disc Disease in Cervical SpineStenosis Cervical Spine

Investigational drug(s) / intervention(s)

Cervical interbody fusion surgery (standalone)

Cervical interbody fusion surgery (standalone): Fortilink-SC

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Willing and able to five voluntary informed consent 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: 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 metastatic 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).

Primary outcome measure(s)

  • Change in NDI score at 12 months follow-up — Improvement in NDI score at 12 months over baseline
    Change between baseline and 12 months follow-up

Trial sites (2)

FacilityCityRegionStatus
Hospital Vithas de la Milagrosa Madrid Madrid Recruiting
Hospital Universitario Vithas Madrid Aravaca Moncloa-Aravaca Madrid Recruiting

More BAAT Medical Products B.V. trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07834749 on ClinicalTrials.gov ↗ ← All trials in Spain