N/A
Completed N=77
The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
Thoracolumbar Disc Degeneration · Thoracolumbar Spondylolisthesis · Spinal deformity · Spinal Degeneration
Source: ClinicalTrials.gov NCT04670536 ↗
Enrolled (actual)
77
Serious AEs
20.8%
Results posted
May 2026
Primary outcomePrimary: Number of Participant Who Achieved Their Fusion at 24 Months — 16; 24; 14 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant Who Achieved Their Fusion at 24 Months |
16; 24; 14 | — |
| SECONDARY Evolution of the Pain (VAS) |
-3; -4.9; -3.3; -3.2; -5; -1.2 | — |
| SECONDARY Quality of Life With ODI |
-17.3; -35.8; -30.1; -19.5; -35.9; -28.7 | — |
| SECONDARY Quality of Life With SF-12 |
4.4; 12.1; 14.2; 6.4; 10.8; 13.0 | — |
| SECONDARY Surgeons'Satisfaction With These Implants and Instruments |
13; 20; 25; 10; 9; 0 | — |
| SECONDARY Fusion Status at the 1/6 Month and 12-month Visit |
0; 0; 21; 5; 19; 14 | — |
| SECONDARY Patient Satisfaction at All Available Postoperative Timepoints |
17; 28; 18; 4; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04670536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.