Skip to main content
OpenTrials
Completed

NCT Number: NCT04670536

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thoracolumbar Disc Degeneration Spinal Deformity Spinal Degeneration Thoracolumbar Spondylolisthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pitié-Salpêtrière AP-HP, Paris, Île-de-France Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PASS LP implants

Device

Thoraco lumbar arthrodesis

PASS DEGEN

Device

Thoraco lumbar arthrodesis

PASS TULIP PRIME

Device

Thoraco lumbar arthrodesis

Primary outcomes

  1. Number of Participant Who Achieved Their Fusion at 24 Months

    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 outcomes

  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 50 (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 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.

  4. 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.

  5. 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

  6. 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)

Sponsors and collaborators

Lead sponsor

Medicrea International

Industry

Registry information

Official study title

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

Acronym: PASS DEGEN

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2020
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.