CompletedNot Applicable

The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)

France77 participantsStarted 2018-05-17

Plain-language summary

The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases. This study is supporting the clinical evaluation report. From the standard-of-care perspective, the results of The Degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients of at least 18 years old * Patient suffering from a spinal degenerative disease. * Patient requiring spinal surgery for less than 4 levels for a spinal degenerative disease * Patient implanted with MEDICREA's products, or patients who are candidate to receive including at least the PASS LP and/or PASS DEGEN and/or PASS TULIP Prime implants * Patient affiliated to a national insurance system Exclusion Criteria: * Patient unable or unwilling to sign and understand an information note with proof of patient consent * Patient unable to complete a self-administered questionnaire * Patient presenting contra-indications to a Xray follow-up * Patient of more than 18 years old under a protection procedure * Patient judged as non-compliant by the investigator or not able to come back for follow-up visits up to 2 years

What they're measuring

Number of Participant Who Achieved Their Fusion at 24 Months

Timeframe: At 24months

Trial details

NCT IDNCT04670536

SponsorMedicrea International

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-05-22

Results submitted2025-09-04