Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff Repair
FIXIT®2018
Verification of the Performance and Safety of the First Row Resorbable Threaded Anchor FIXIT® in Arthroscopic Rotator Cuff Repair as Part of the Post-marketing Follow-up of Device
1 other identifier
observational
30
1 country
2
Brief Summary
Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing follow-up of devices
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2018
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedFirst Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 9, 2023
CompletedFebruary 9, 2023
February 1, 2023
1.8 years
January 27, 2023
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Sugaya classification
Radiological evaluation to assess the absence of rotator cuff re-tears with the Sugaya classification and the retraction's degree of the cuff.
1 year postoperative
Secondary Outcomes (4)
Constant score
45 days, 5months and 1 year postoperative
Pain score
45 days, 5months and 1 year postoperative
Quick DASH score
45 days, 5months and 1 year postoperative
Fatty degeneration
preoperative
Study Arms (1)
Study group
There was only one group as the study was a non-comparative study
Interventions
Arthroscopic transosseous reinsertion of the rotator cuff is the most widely used arthroscopic technique. The tendons are repositioned on the greater and lesser tuberosities of the humerus with specific anchors. These anchors, placed in the humeral bone, are attached to sutures which are in turn tied to the tendon.
Eligibility Criteria
A total of 30 patients, aged between 45 to 78 and operated for a rotator cuff repair were selected in this study. Initially, 31 patients were included but 1 withdrew from the study.
You may qualify if:
- Patient with broken tendinopathy of the rotator cuff
- Patient over 18 years old
- Patient who has received complete medical information and not objecting to participate in research
- Social insured patient
You may not qualify if:
- Pregnant or likely to be pregnant, or breastfeeding
- Patient under guardianship
- Non-cooperative patient, who does not want or is unable to follow the post-operative instructions (drug addict or alcoholic patient in particular)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Polyclinique de l'Ormeau
Tarbes, France
CH Purpan
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas BONNEVIALLE, Pr
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2023
First Posted
February 9, 2023
Study Start
December 12, 2018
Primary Completion
September 14, 2020
Study Completion
July 31, 2022
Last Updated
February 9, 2023
Record last verified: 2023-02