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

Medicrea International77 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Thoracolumbar Disc Degeneration Thoracolumbar Spondylolisthesis Spinal Deformity Spinal Degeneration

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Clinique du Dos Bordeaux - Terrefort

Bruges, France

Clinique des Cèdres

Cornebarrieu, France

CHRU Tours, Hôpital de Bretonneau

Tours, France

Hôpital Pitié-Salpêtrière AP-HP

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

Fusion

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.

Time frame: At 24months

Secondary Outcomes

Evolution of the pain (VAS)

Change of leg and back pain score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 10 (worst)

Time frame: Preoperative, and 1-6, 12 and 24 months postoperative

Quality of life with ODI

Change of non-validated ODI score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 5 (worst)

Time frame: Preoperative, and 1-6, 12 and 24 months postoperative

Quality of life with SF-12

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)

Time frame: Preoperative, and 1-6, 12 and 24 months postoperative

Device or procedure-related adverse events and all SAEs up to 24 months

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.

Time frame: Preoperative, and 1-6, 12 and 24 months postoperative

Surgeons'satisfaction with these implants and instruments

Surgeons will be requested to complete questions about device/surgery satisfaction.

Time frame: During the surgery and until the 24months postoperative visit

Fusion status at the 1/6 month and 12-month visit

The primary objective is defined as the ability of the implant to promote the stabilization

Time frame: At the 1-6, and 12 months postoperative

Patient satisfaction at all available postoperative timepoints

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)

Time frame: At 1-6, 12 and 24 months postoperative

Data from ClinicalTrials.gov

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