Safety of Treatment of Shoulder Repair

Completed

Conditions studied: Rotator Cuff

In brief

This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair

Key facts

Study ID

NCT04552119

Run by

Smith & Nephew, Inc.

People needed

138

Starts

2021-01-26

Expected to finish

2024-05-24

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Requires reattachment of soft tissue to bone for the following shoulder indications:
• Rotator Cuff Tendon repair:
• i. Single or double row rotator cuff repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping; OR
• ii. Double row rotator cuff repair using HEALICOIL Knotless RG NST in lateral row (existing HEALICOIL RG device to be used in medial row of the repair); AND/OR
• Biceps tenodesis
• i. In conjunction with Rotator Cuff Tendon repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, HEALICOIL Knotless RG NST or HEALICOIL Knotless RG Self-Tapping OR
• ii. As a stand-alone procedure for HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping (not HEALICOIL Knotless RG NST
• Has a pre-operative MRI collected within 6 months of surgery which meets one of the following criteria:
• MRI collected as standard-of-care has been submitted to external imaging vendor and confirmed as acceptable OR
• If standard-of-care images are unavailable or considered unacceptable by external imaging vendor, subject must undergo an additional study-specific pre- operative MRI, confirmed as acceptable by external imaging vendor OR
• MRI not required; subject not in HEALICOIL Knotless RG NST subgroup
• Has consented to participate in the study by signing the IRB/IEC approved informed consent form.
• Requires only one variant of the HEALICOIL Knotless Suture Anchor
• Is ≥18 years of age at time of surgery
• Willing and able to make all required study visits
• Able to follow instructions (Approved translated documents supplied upon request)

You may not qualify if…

• Any one (1) of the following criteria will disqualify a potential subject from participation in the study:
• Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
• Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
• Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
• Comminuted bone surface, which would compromise secure anchor fixation.
• Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing
• The presence of infection.
• Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
• Concurrent bilateral surgery.
• Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
• Women who are pregnant.
• Prior ipsilateral surgeries performed on the joint space.
• Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Where it is running

• University of Stanford — Redwood City, California, United States
• Orthopaedic and Spine Center of Southern Colorado — Colorado Springs, Colorado, United States
• University of Colorado - Denver — Denver, Colorado, United States
• OrthoIllinois LTD — Rockford, Illinois, United States
• University Orthopedics Center — Altoona, Pennsylvania, United States

Full record on ClinicalTrials.gov

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