Clinical trial NCT04670536: The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
Official title: The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracolumbar Disc Degeneration
Thoracolumbar Spondylolisthesis
Spinal Deformity
Spinal Degeneration
Lead sponsor: Medicrea International
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients

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).


Eligibility criteria: 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

Primary outcomes:
measure: Fusion
timeFrame: At 24months
Secondary outcomes:
measure: Evolution of the pain (VAS)
timeFrame: Preoperative, and 1-6, 12 and 24 months postoperative
measure: Quality of life with ODI
timeFrame: Preoperative, and 1-6, 12 and 24 months postoperative
measure: Quality of life with SF-12
timeFrame: Preoperative, and 1-6, 12 and 24 months postoperative
measure: Device or procedure-related adverse events and all SAEs up to 24 months
timeFrame: Preoperative, and 1-6, 12 and 24 months postoperative
measure: Surgeons'satisfaction with these implants and instruments
timeFrame: During the surgery and until the 24months postoperative visit
measure: Fusion status at the 1/6 month and 12-month visit
timeFrame: At the 1-6, and 12 months postoperative
measure: Patient satisfaction at all available postoperative timepoints
timeFrame: At 1-6, 12 and 24 months postoperative
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière AP-HP
state: Ile de France
city: Bruges
country: France
facility: Clinique du Dos Bordeaux - Terrefort
city: Cornebarrieu
country: France
facility: Clinique des Cèdres
city: Tours
country: France
facility: CHRU Tours, Hôpital de Bretonneau
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.