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

Rotator Cuff Injuries Clinical Trial

— FIXIT®2018  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05720286
• Other study ID #: 2018-A02653-52
• Status: Completed
• Start date: December 12, 2018
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2023
• Source: Science and biomaterials
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2022
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

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.

Locations

Country	Name	City	State
France	Polyclinique de l'Ormeau	Tarbes
France	CH Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Science and biomaterials

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Constant score	Functional score	45 days, 5months and 1 year postoperative
Secondary	Pain score	EVA pain scale	45 days, 5months and 1 year postoperative
Secondary	Quick DASH score	Capacity of shoulder score	45 days, 5months and 1 year postoperative
Secondary	Fatty degeneration	Bernageau classification	preoperative