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Completed

NCT Number: NCT05720286

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

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

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Key information

Conditions

Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Polyclinique de l'Ormeau, Tarbes, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Arthroscopic rotator cuff repair

Device

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.

Primary outcomes

  1. Sugaya classification

    Time frame: 1 year postoperative

    Radiological evaluation to assess the absence of rotator cuff re-tears with the Sugaya classification and the retraction's degree of the cuff.

Secondary outcomes

  1. Constant score

    Time frame: 45 days, 5months and 1 year postoperative

    Functional score

  2. Pain score

    Time frame: 45 days, 5months and 1 year postoperative

    EVA pain scale

  3. Quick DASH score

    Time frame: 45 days, 5months and 1 year postoperative

    Capacity of shoulder score

  4. Fatty degeneration

    Time frame: preoperative

    Bernageau classification

Sponsors and collaborators

Lead sponsor

Science and biomaterials

Industry

Registry information

Official study 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

Acronym: FIXIT®2018

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Feb 9, 2023
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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