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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Spinal Deformity; Spinal Degeneration; Thoracolumbar Disc Degeneration; Thoracolumbar Spondylolisthesis
• Intervention / Treatment: Device: PASS LP implants; Device: PASS DEGEN; Device: PASS TULIP PRIME

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

Study Locations

• France
  • Bruges, France, 33520
    • Clinique du Dos Bordeaux - Terrefort
  • Cornebarrieu, France, 31700
    • Clinique des Cèdres
  • Tours, France, 37044
    • CHRU Tours, Hôpital de Bretonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PASS LP implants; Patient suffering from a spinal degenerative disease and who is operated with PASS LP	Device: PASS LP implants; Thoraco lumbar arthrodesis
PASS Degen implants; Patient suffering from a spinal degenerative disease and who is operated with PASS DEGEN	Device: PASS DEGEN; Thoraco lumbar arthrodesis
PASS Tulip PRIME implants; Patient suffering from a spinal degenerative disease and who is operated with PASS TULIP PRIME	Device: PASS TULIP PRIME; Thoraco lumbar arthrodesis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medicrea International

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Estimated): October 27, 2024
• Study Completion (Estimated): October 27, 2024

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: 0313

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No