PASS OCT® Post-market Clinical Follow-up
|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: NCT02931279|
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : October 13, 2016
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
The inclusion period will be 12 months and the follow-up 24 months
|Condition or disease||Intervention/treatment|
|Intervertebral Disc Disease Spondylolisthesis Spinal Stenosis Spinal Neoplasms Spinal Fractures||Device: PASS OCT® Spinal System|
The primary endpoint is to evaluate the safety of the PASS OCT® system.
The secondary endpoints are to analyze the efficacy of the system with several point of view:
- The quality of fusion and the time of fusion through X rays
- the pain with VAS
- the quality of life thanks to questionnaires: NDI (Neck Disability Index) and JOA for myelopathy
- the daily of the patient: return to work, sport
- the surgeon satisfaction.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Device: PASS OCT® Spinal System
- Adverse events [ Time Frame: 12 months postoperatively ]To quantify and describe adverse events
- Fusion [ Time Frame: 1-6 months, 12 months, 24 months postoperatively ]Radiological assessment of bony fusion
- Disability [ Time Frame: 1-6 months, 12 months, 24 months postoperatively ]To assess disability using NDI score
- Quality of life [ Time Frame: 1-6 months, 12 months, 24 months postoperatively ]To assess quality of life through mJOA scoring system
- Pain [ Time Frame: 1-6 months, 12 months, 24 months postoperatively ]To assess pain using visual analogue scale
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): NCT02931279
|Contact: Estelle Douceron, PhDfirstname.lastname@example.org|
|Hopital la Timone||Recruiting|
|Contact: Stephane Fuentes, MD|
|Contact: Benjamin Blondel, MD|
|Principal Investigator:||Stephane Fuentes, MD||Hopital la Timone, Marseille|