Status:
COMPLETED
The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
Lead Sponsor:
Medicrea International
Conditions:
Thoracolumbar Disc Degeneration
Thoracolumbar Spondylolisthesis
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04670536
Start Date
May 17 2018
End Date
May 22 2024
Last Update
January 13 2025
Active Locations (4)
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1
Clinique du Dos Bordeaux - Terrefort
Bruges, France, 33520
2
Clinique des Cèdres
Cornebarrieu, France, 31700
3
CHRU Tours, Hôpital de Bretonneau
Tours, France, 37044
4
Hôpital Pitié-Salpêtrière AP-HP
Paris, Île-de-France Region, France, 75651