Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff Repair (FIXIT®2018)

Science and biomaterials

Status: Completed

Conditions: Rotator Cuff Injuries

Treatments: Device: Arthroscopic rotator cuff repair

Study type: Observational

Funder types: Industry

Identifiers

NCT05720286

2018-A02653-52

Details and patient eligibility

About

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

Full description

the main objective of this study was to verify the safety of the resorbable threaded anchor FIXIT®, used in arthroscopic rotator cuff repair. This objective was to be imaging assessed (echography, MRI) for the presence or absence of a rotator cuff re-tear and its degree of retractation. The second objective was to verify the performance of the FIXIT® anchor with 4 scoring criteria : Constant score, pain score EVA, Quick DASH score and Bernageau classification

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

30 participants in 1 patient group

Study group

Description:

There was only one group as the study was a non-comparative study

Treatment:

Device: Arthroscopic rotator cuff repair