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

Completed

• Conditions: Thoracolumbar Disc Degeneration; Thoracolumbar Spondylolisthesis; Spinal Deformity; Spinal Degeneration
• Interventions: Device: PASS DEGEN; Device: PASS TULIP PRIME; Device: PASS LP implants

• Registration Number: NCT04670536
• Lead Sponsor: Medicrea International

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 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-17
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-17
• Primary Completion: 2024-05-22
• Study Completion: 2024-05-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PASS Degen implants	PASS DEGEN	Patient suffering from a spinal degenerative disease and who is operated with PASS DEGEN
PASS Tulip PRIME implants	PASS TULIP PRIME	Patient suffering from a spinal degenerative disease and who is operated with PASS TULIP PRIME
PASS LP implants	PASS LP implants	Patient suffering from a spinal degenerative disease and who is operated with PASS LP

Primary Outcome Measures

Name	Time	Method
Fusion	At 24months	The primary endpoint is the fusion status of each patient at the 24-month visit postoperative. This fusion assessment will be done through the analysis of the standard of care imaging (CT-scan, X-rays, and/or MRI) by the investigator and through the clinical examination of the patient by the investigator.

Secondary Outcome Measures

Name	Time	Method
Quality of life with SF-12	Preoperative, and 1-6, 12 and 24 months postoperative	Change of non-validated SF-12 score from the preoperative visit to all available postoperative timepoints: from to 0 (better) to 3 or 5 depending the question (worst)
Surgeons'satisfaction with these implants and instruments	During the surgery and until the 24months postoperative visit	Surgeons will be requested to complete questions about device/surgery satisfaction.
Fusion status at the 1/6 month and 12-month visit	At the 1-6, and 12 months postoperative	The primary objective is defined as the ability of the implant to promote the stabilization
Device or procedure-related adverse events and all SAEs up to 24 months	Preoperative, and 1-6, 12 and 24 months postoperative	During the follow-up period, the occurrence of device and procedure related AEs and all serious adverse events will be monitored, registered, and analyzed. To safeguard the safety of the clinical study subjects, all SAEs will be collected even those that may not be directly related to the surgery.
Evolution of the pain (VAS)	Preoperative, and 1-6, 12 and 24 months postoperative	Change of leg and back pain score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 10 (worst)
Patient satisfaction at all available postoperative timepoints	At 1-6, 12 and 24 months postoperative	Patient satisfaction is used to evaluate patient satisfaction after surgery and during the follow-up period.; Satisfaction is measured at four different levels: 1 (better) to 4 (worst)
Quality of life with ODI	Preoperative, and 1-6, 12 and 24 months postoperative	Change of non-validated ODI score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 5 (worst)

Trial Locations

Locations (4)

Hôpital Pitié-Salpêtrière AP-HP; 🇫🇷 Paris, Ile de France, France

Clinique des Cèdres; 🇫🇷 Cornebarrieu, France

Clinique du Dos Bordeaux - Terrefort; 🇫🇷 Bruges, France

CHRU Tours, Hôpital de Bretonneau; 🇫🇷 Tours, France