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

Study Overview
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Brief Summary
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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).

Official Title
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The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.

Conditions
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Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis, Spinal Deformity, Spinal Degeneration

Intervention / Treatment
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* Device: PASS LP implants
* Device: PASS DEGEN
* Device: PASS TULIP PRIME


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PASS LP implants<br>Patient suffering from a spinal degenerative disease and who is operated with PASS LP | Device: PASS LP implants<br>* Thoraco lumbar arthrodesis<br>|
| PASS Degen implants<br>Patient suffering from a spinal degenerative disease and who is operated with PASS DEGEN | Device: PASS DEGEN<br>* Thoraco lumbar arthrodesis<br>|
| PASS Tulip PRIME implants<br>Patient suffering from a spinal degenerative disease and who is operated with PASS TULIP PRIME | Device: PASS TULIP PRIME<br>* Thoraco lumbar arthrodesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 24months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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. | 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. | 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 | 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) | At 1-6, 12 and 24 months postoperative |