Fortilink-TC Ti cage use in lumbar fusion for back pain

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 real-world data to evaluate the safety and performance of the Fortilink-TC Ti interbody fusion cage used during transforaminal lumbar interbody fusion procedures. About 50 participants will be enrolled across two hospitals and followed for up to one year, using data from routine care. No change in standard treatment or follow-up is required beyond typical clinical practice. The study records preoperative history, operative details, and postoperative outcomes to monitor device performance in the intended patient population. Fortilink-TC Ti cages have been on the market since 2020 and are being studied to confirm ongoing safety and effectiveness in this specific indication.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing and able to give voluntary informed consent
2. Skeletally mature patients
3. At least 6 months of non-operative treatment
4. 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• IDCT (Intradiscal Cell Therapy) for single-level mild-to-moderate lumbar degenerative disc disease

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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.