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Thoracolumbar Disc DegenerationPASS DEGENNCT04670536

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

An observational study of Thoracolumbar Disc Degeneration and Thoracolumbar Spondylolisthesis, run by Medicrea International at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PASS LP implants, PASS DEGEN and PASS TULIP PRIME
Type of treatment
Medical device
How many people
77 participants
Where
4 sitesFrance
Study dates
17 May 2018to 22 May 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Clinique du Dos Bordeaux - Terrefort

    Bruges, 33520

  • Clinique des Cèdres

    Cornebarrieu, 31700

  • Hôpital Pitié-Salpêtrière AP-HP

    Paris, Île-de-France Region, 75651

  • CHRU Tours, Hôpital de Bretonneau

    Tours, 37044

Other trials in France

About this study

Official title: 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).

Being tested
PASS LP implants, PASS DEGEN, PASS TULIP PRIME

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PASS LP implantsDevice

    Thoraco lumbar arthrodesis

  • PASS DEGENDevice

    Thoraco lumbar arthrodesis

  • PASS TULIP PRIMEDevice

    Thoraco lumbar arthrodesis

Study groups in NCT04670536
Study groupRoleWhat they receive
PASS LP implantsPatient suffering from a spinal degenerative disease and who is operated with PASS LP
Receives: Device: PASS LP implants
PASS Degen implantsPatient suffering from a spinal degenerative disease and who is operated with PASS DEGEN
Receives: Device: PASS DEGEN
PASS Tulip PRIME implantsPatient suffering from a spinal degenerative disease and who is operated with PASS TULIP PRIME
Receives: Device: PASS TULIP PRIME

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 24months

Secondary outcomes (6)

  1. 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)

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

  2. Quality of Life With ODI

    Change of non-validated ODI score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 50 (worst)

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

  3. 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 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.

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

  4. Surgeons'Satisfaction With These Implants and Instruments

    Surgeons will be requested to complete questions about device/surgery satisfaction.

    Measured: During the surgery and until the 24months postoperative visit

  5. 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

    Measured: At the 1-6, and 12 months postoperative

  6. 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)

    Measured: At 1-6, 12 and 24 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start17 May 2018
  3. Primary completion22 May 2024
  4. Study completion22 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670536
Sponsor's protocol ID
0313
Acronym
PASS DEGEN
Status last verified
Apr 2026
First submitted
3 Dec 2020
Last updated
1 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 18201937

  • 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.

    PubMed 12592542

  • 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.

    PubMed 18805059

  • 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.

    PubMed 24206036

  • 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.

    PubMed 11074683

  • 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.

    PubMed 23622053

  • 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.

    PubMed 23590789

  • 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.

    PubMed 24980580

  • 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.

    PubMed 9817135

Questions about this trial

What is this clinical trial studying?

An observational study of Thoracolumbar Disc Degeneration and Thoracolumbar Spondylolisthesis, run by Medicrea International at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participant Who Achieved Their Fusion at 24 Months (time frame: At 24months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04670536, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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