Spinal Deformity Clinical Trial
— PASS DEGENOfficial title:
The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.
Verified date | August 2023 |
Source | Medicrea International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | October 27, 2024 |
Est. primary completion date | October 27, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Clinique du Dos Bordeaux - Terrefort | Bruges | |
France | Clinique des Cèdres | Cornebarrieu | |
France | CHRU Tours, Hôpital de Bretonneau | Tours |
Lead Sponsor | Collaborator |
---|---|
Medicrea International |
France,
Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16. — View Citation
Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017. — View Citation
Fairbank JC. Why are there different versions of the Oswestry Disability Index? J Neurosurg Spine. 2014 Jan;20(1):83-6. doi: 10.3171/2013.9.SPINE13344. Epub 2013 Nov 8. — View Citation
Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7. — View Citation
Ghogawala Z, Whitmore RG, Watters WC 3rd, Sharan A, Mummaneni PV, Dailey AT, Choudhri TF, Eck JC, Groff MW, Wang JC, Resnick DK, Dhall SS, Kaiser MG. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 3: assessment of economic outcome. J Neurosurg Spine. 2014 Jul;21(1):14-22. doi: 10.3171/2014.4.SPINE14259. — View Citation
Glassman SD, Carreon LY, Djurasovic M, Dimar JR, Johnson JR, Puno RM, Campbell MJ. Lumbar fusion outcomes stratified by specific diagnostic indication. Spine J. 2009 Jan-Feb;9(1):13-21. doi: 10.1016/j.spinee.2008.08.011. Epub 2008 Sep 19. — View Citation
Gum JL, Carreon LY, Stimac JD, Glassman SD. Predictors of Oswestry Disability Index worsening after lumbar fusion. Orthopedics. 2013 Apr;36(4):e478-83. doi: 10.3928/01477447-20130327-26. — View Citation
Hagg O, Fritzell P, Nordwall A; Swedish Lumbar Spine Study Group. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003 Feb;12(1):12-20. doi: 10.1007/s00586-002-0464-0. Epub 2002 Oct 24. — View Citation
Johnsen LG, Hellum C, Nygaard OP, Storheim K, Brox JI, Rossvoll I, Leivseth G, Grotle M. Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease. BMC Musculoskelet Disord. 2013 Apr 26;14:148. doi: 10.1186/1471-2474-14-148. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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