Surgical Safety Following Rotator Cuff Repair Using FiberLocker® System

Overview

About this study

Primary Research Aim

  • To assess the safety profile of the FiberLocker® System

    • Measured by frequency and rates of device- related adverse events (AEs) and serious adverse events (SAEs) throughout the study

    • Target <5% Adverse Effects

 

Secondary Research Aims

  1. To assess postoperative healing following rotator cuff repair augmented with the FiberLocker® System

    • Measurement: MRI at 12 months

    • Target: ≥90% healed tendon at 12 months

  2. To assess patient reported pain and shoulder function

    • Instruments: ASES, VAS, SANE, ROM

    • Target: Meeting MCID thresholds for validated outcome measures at 12 months

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

This study will enroll adults patients undergoing arthroscopic rotator cuff repair at Mayo Clinic Rochester. Eligible participants will be identified from the clinical practices of the study investigators and screened for eligibility prior to enrollment. Written informed consent will be obtained before any study‑related procedures are performed.

 

Inclusion Criteria:

·         Age 30 to 85  years

·         Scheduled to undergo primary arthroscopic repair of a full‑thickness rotator cuff tear

·         Tear size ≥ 2 cm

·         Planned use of the FiberLocker® System as part of the surgical repair

·         Availability of a preoperative MRI obtained within 12 months prior to surgery

·         Ability to provide written informed consent, or availability of a legally authorized representative to do so

 

Exclusion Criteria: 

·         Any medical or clinical condition that, in the opinion of the investigator, would compromise subject safety or interfere with interpretation of study results

·         Membership in a vulnerable population, including but not limited to children, prisoners, or individuals with impaired decision‑making capacity

·         Pregnancy at the time of enrollment

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jonathan Barlow, M.D.

Contact us for the latest status

Contact information:

Lucille Anderson

5075385627

anderson.luci@mayo.edu

More information

Publications

Publications are currently not available