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

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Device: Arthroscopic rotator cuff repair

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Tarbes, France
    • Polyclinique de l'Ormeau
  • Toulouse, France, 31000
    • CH Purpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; There was only one group as the study was a non-comparative study	Device: Arthroscopic rotator cuff repair; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant score	Functional score	45 days, 5months and 1 year postoperative
Pain score	EVA pain scale	45 days, 5months and 1 year postoperative
Quick DASH score	Capacity of shoulder score	45 days, 5months and 1 year postoperative
Fatty degeneration	Bernageau classification	preoperative

Collaborators and Investigators

• Sponsor: Science and biomaterials
• Investigators: Principal Investigator: Nicolas BONNEVIALLE, Pr

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2018
• Primary Completion (ACTUAL): September 14, 2020
• Study Completion (ACTUAL): July 31, 2022

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (ESTIMATE): February 9, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2018-A02653-52

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No