Spinal Deformity, Spinal Degeneration, Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis
Conditions
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).
Interventions
DEVICEPASS LP implants
Thoraco lumbar arthrodesis
DEVICEPASS DEGEN
Thoraco lumbar arthrodesis
DEVICEPASS TULIP PRIME
Thoraco lumbar arthrodesis
Sponsors
Medicrea International
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant Who Achieved Their Fusion at 24 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 50 (worst) |
| 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 5 (worst) by question, then questions are combined following the SF12 provider recommendation. The scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS and MCS can be between O and 100. |
| 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 |
| 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) |
Countries
France
Participant flow
Pre-assignment details
Only subjects implanted with one of 3 products listed in the protocol can included and considered as participant. Knowing that 1 investigational site corresponds to only one type of products used.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.3 Years STANDARD_DEVIATION 10.8 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 1 / 29 | 0 / 25 |
| other Total, other adverse events | 5 / 23 | 0 / 29 | 0 / 25 |
| serious Total, serious adverse events | 4 / 23 | 5 / 29 | 7 / 25 |
Outcome results
None listed