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

NCT04670536 | Completed Results

• 1 other identifier: 0313
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 4

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).

Conditions

Thoracolumbar Spondylolisthesis; Spinal Deformity; Thoracolumbar Disc Degeneration; Spinal Degeneration

Outcome Measures

Primary Outcomes (1)

• Number of Participant Who Achieved Their Fusion at 24 Months

  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 Outcomes (6)

• Evolution of the Pain (VAS)

  Preoperative, and 1-6, 12 and 24 months postoperative

• Quality of Life With ODI

  Preoperative, and 1-6, 12 and 24 months postoperative

• Quality of Life With SF-12

  Preoperative, and 1-6, 12 and 24 months postoperative

• Surgeons'Satisfaction With These Implants and Instruments

  During the surgery and until the 24months postoperative visit

• Fusion Status at the 1/6 Month and 12-month Visit

  At the 1-6, and 12 months postoperative

Study Arms (3)

PASS LP implants

Patient suffering from a spinal degenerative disease and who is operated with PASS LP

Device: PASS LP implants

PASS Degen implants

Patient suffering from a spinal degenerative disease and who is operated with PASS DEGEN

Device: PASS DEGEN

PASS Tulip PRIME implants

Patient suffering from a spinal degenerative disease and who is operated with PASS TULIP PRIME

Device: PASS TULIP PRIME

Interventions

PASS LP implants DEVICE

Thoraco lumbar arthrodesis

PASS LP implants

PASS DEGEN DEVICE

Thoraco lumbar arthrodesis

PASS Degen implants

PASS TULIP PRIME DEVICE

Thoraco lumbar arthrodesis

PASS Tulip PRIME implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicrea International: lead

Study Sites (4)

Clinique du Dos Bordeaux - Terrefort

Bruges, 33520, France

Location

Clinique des Cèdres

Cornebarrieu, 31700, France

Location

CHRU Tours, Hôpital de Bretonneau

Tours, 37044, France

Location

Hôpital Pitié-Salpêtrière AP-HP

Paris, Île-de-France Region, 75651, France

Location

Related Publications (9)

• 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.

  PMID: 18201937 BACKGROUND

• 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.

  PMID: 12592542 BACKGROUND

• 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.

  PMID: 18805059 BACKGROUND

• 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.

  PMID: 24206036 BACKGROUND

• 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.

  PMID: 11074683 BACKGROUND

• 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.

  PMID: 23622053 BACKGROUND

• 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.

  PMID: 23590789 BACKGROUND

• 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.

  PMID: 24980580 BACKGROUND

• 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.

  PMID: 9817135 BACKGROUND

Limitations and Caveats

The SF12 is a non validated revision.

Results Point of Contact

• Title: Carole Bergougnoux
• Organization: Medtronic - Medicrea

dl.affairescliniques@medtronic.com

+33472018787

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 17, 2020
• Study Start: May 17, 2018
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Locations

FR (4)