CompletedNot Applicable

Safety of Treatment of Shoulder Repair

United States138 participantsStarted 2021-01-26

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Requires reattachment of soft tissue to bone for the following shoulder indications:
✓. Rotator Cuff Tendon repair:
✓. Biceps tenodesis
✓. 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.

✕. 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.

Clinical Success Rate at 6 Months

Timeframe: 6 months

NCT IDNCT04552119

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-05-24

Results submitted2026-03-27

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Requires reattachment of soft tissue to bone for the following shoulder indications:
✓. Rotator Cuff Tendon repair:
✓. Biceps tenodesis
✓. 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.

✕. 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.