Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04670536
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Medicrea International

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This post-market clinical follow-up study aims to collect some data about the performance and safety of MEDICREA's products to treat thoraco-lumbar degenerative diseases(PASS LP, PASS DEGEN, and TULIP PRIME). This study is supporting the clinical evaluation report. In addition, a subgroup is added to collect post-market clinical data on the use of TULIP Genesis medical devices for both degenerative and deformity indications.

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 Device: PASS TULIP GENESIS

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 125 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 : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
PASS Tulip GENESIS implants
Patient suffering from a deformity and who is operated with PASS TULIP GENESIS implant(s)
 Device: PASS TULIP GENESIS
Thoraco lumbar arthrodesis


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Fusion [ Time Frame: At 24months ]
    The primary objective is defined as the ability of the implant to promote the stabilization and/or the fusion of the instrumented segments at the last follow-up. Measures the bone fusion thanks to the Xrays judged by the investigator


Secondary Outcome Measures :
  1. Evolution of the pain (VAS) [ Time Frame: Preoperative, and 1-6, 12 and 24 months postoperative ]
    Score of the pain (to 0 (better) to 10 (worst)

  2. Quality of life with ODI [ Time Frame: Preoperative, and 1-6, 12 and 24 months postoperative ]
    Score of the pain (to 0 (better) to 50 (worst)

  3. Quality of life with SF-12 [ Time Frame: Preoperative, and 1-6, 12 and 24 months postoperative ]
    Score of the SF-12 (to 0 (better) to 100 (worst)

  4. Complications (AE/SAE) [ Time Frame: Preoperative, and 1-6, 12 and 24 months postoperative ]
    list all complications to calculate the rate of intraoperative and postoperative complications

  5. Surgeons'satisfaction with these implants and instruments [ Time Frame: During the surgery and until the 24months postoperative visit ]
  6. Fusion [ 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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:

  • Patient suffering from a spinal degenerative disease or Patient suffering from a deformity (who is operated only with PASS TULIP GENESIS implant(s))
  • Patient of at least 18 years old
  • Patient requiring spinal surgery for less than 4 levels for a spinal degenerative disease OR more than 4 levels for a deformity disease
  • Patient implanted with MEDICREA's products, including at least PASS LP and/or PASS Degen and/or PASS Tulip implants
  • Patient affiliated to a national insurance system

Exclusion Criteria:

  • Patient unable or unwilling to sign and understand an informed consent form
  • 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Contacts
Layout table for location contacts
Contact: Caroline Leblanc 0472018787 clinicalstudy@medicrea.com

Locations
Layout table for location information
France
Clinique Orthopole Recruiting
Bruges, France, 33520
Contact: Louis Boissière         
Principal Investigator: Louis Boissière         
Clinique des Cèdres Recruiting
Cornebarrieu, France, 31700
Contact: Olivier Hamel         
Sub-Investigator: Olivier Hamel         
Principal Investigator: Pascal Sabatier         
Hôpital La Pitié Salpêtrière Recruiting
Paris, France, 75651
Contact: Aymeric Amelot         
Principal Investigator: Aymeric Amelot         
Sponsors and Collaborators
Medicrea International
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Medicrea International
ClinicalTrials.gov Identifier: NCT04670536    
Other Study ID Numbers: 0313
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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