Fortilink-SC cervical fusion safety and performance in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects data from routine care to monitor safety and performance of the Fortilink-SC Ti cage used in cervical interbody fusion. About 50 participants are enrolled across two Madrid hospitals and followed for up to one year. Data gathered include medical history, intraoperative details, and postoperative follow-up consistent with standard care. The study does not alter the treatment or follow-up procedures for participants. Fortilink-SC Ti cages have been on the market since 2020, and this study aims to actively gather real-world evidence in the intended patient population.

Why it matters

Who can join: the full rules

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).

Where it's running

• Hospital Vithas de la Milagrosa
  Madrid, Madrid, Spain Recruiting
• Hospital Universitario Vithas Madrid Aravaca
  Moncloa-Aravaca, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Tess Jimenez - van Dam, MSc
• Email: tess@baatmedical.com
• Phone: +31 - (0)6 - 267 18 663

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.