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

Tracking Information
First Submitted Date December 3, 2020
First Posted Date December 17, 2020
Last Update Posted Date December 17, 2020
Actual Study Start Date May 17, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 10, 2020)
  • 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)
  • 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)
  • 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)
  • 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
  • Surgeons'satisfaction with these implants and instruments [ Time Frame: During the surgery and until the 24months postoperative visit ]
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients
Condition
  • Thoracolumbar Disc Degeneration
  • Thoracolumbar Spondylolisthesis
  • Spinal Deformity
  • Spinal Degeneration
Intervention
  • Device: PASS LP implants
    Thoraco lumbar arthrodesis
  • Device: PASS DEGEN
    Thoraco lumbar arthrodesis
  • Device: PASS TULIP PRIME
    Thoraco lumbar arthrodesis
  • Device: PASS TULIP GENESIS
    Thoraco lumbar arthrodesis
Study Groups/Cohorts
  • PASS LP implants
    Patient suffering from a spinal degenerative disease and who is operated with PASS LP
    Intervention: Device: PASS LP implants
  • PASS Degen implants
    Patient suffering from a spinal degenerative disease and who is operated with PASS DEGEN
    Intervention: Device: PASS DEGEN
  • PASS Tulip PRIME implants
    Patient suffering from a spinal degenerative disease and who is operated with PASS TULIP PRIME
    Intervention: Device: PASS TULIP PRIME
  • PASS Tulip GENESIS implants
    Patient suffering from a deformity and who is operated with PASS TULIP GENESIS implant(s)
    Intervention: Device: PASS TULIP GENESIS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 10, 2020)
125
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Caroline Leblanc 0472018787 clinicalstudy@medicrea.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04670536
Other Study ID Numbers 0313
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Medicrea International
Study Sponsor Medicrea International
Collaborators Not Provided
Investigators Not Provided
PRS Account Medicrea International
Verification Date December 2020