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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04670536
Recruitment Status : Active, not recruiting
First Posted : December 17, 2020
Last Update Posted : August 23, 2022
Sponsor:
Information provided by (Responsible Party):
Medicrea International

Study Description
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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).

Condition or disease Intervention/treatment
Thoracolumbar Disc Degeneration Thoracolumbar Spondylolisthesis Spinal Deformity Spinal Degeneration Device: PASS LP implants Device: PASS DEGEN Device: PASS TULIP PRIME

Study Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems.
Actual Study Start Date : May 17, 2018
Estimated Primary Completion Date : October 27, 2024
Estimated Study Completion Date : October 27, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Fusion [ Time Frame: At 24months ]
    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.


Secondary Outcome Measures :
  1. Evolution of the pain (VAS) [ Time Frame: Preoperative, and 1-6, 12 and 24 months postoperative ]
    Change of leg and back pain score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 10 (worst)

  2. Quality of life with ODI [ Time Frame: Preoperative, and 1-6, 12 and 24 months postoperative ]
    Change of non-validated ODI score from the preoperative visit to all available postoperative timepoints: from 0 (better) to 5 (worst)

  3. Quality of life with SF-12 [ Time Frame: Preoperative, and 1-6, 12 and 24 months postoperative ]
    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)

  4. Device or procedure-related adverse events and all SAEs up to 24 months [ Time Frame: Preoperative, and 1-6, 12 and 24 months postoperative ]
    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.

  5. Surgeons'satisfaction with these implants and instruments [ Time Frame: During the surgery and until the 24months postoperative visit ]
    Surgeons will be requested to complete questions about device/surgery satisfaction.

  6. Fusion status at the 1/6 month and 12-month visit [ Time Frame: At the 1-6, and 12 months postoperative ]
    The primary objective is defined as the ability of the implant to promote the stabilization

  7. Patient satisfaction at all available postoperative timepoints [ Time Frame: At 1-6, 12 and 24 months postoperative ]

    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)



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04670536


Locations
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France
Clinique du Dos Bordeaux - Terrefort
Bruges, France, 33520
Clinique des Cèdres
Cornebarrieu, France, 31700
CHRU Tours, Hôpital de Bretonneau
Tours, France, 37044
Sponsors and Collaborators
Medicrea International
More Information
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Publications:

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Responsible Party: Medicrea International
ClinicalTrials.gov Identifier: NCT04670536    
Other Study ID Numbers: 0313
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: August 23, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylolisthesis
Intervertebral Disc Degeneration
Spondylolysis
Spondylosis
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases