Safety of Treatment of Shoulder Repair

NCT04552119 | Completed Results FDA Device

• 1 other identifier: HEALICOIL.KNOTLESS.2019.12
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Rotator Cuff

Keywords

Rotator cuff; shoulder repair; HEALICOIL

Outcome Measures

Primary Outcomes (1)

• Clinical Success Rate at 6 Months

  Clinical success was identified by the repair failure rate defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.

  6 months

Secondary Outcomes (10)

• Clinical Success Rate at 12 Months

  12 months

• Clinical Success Rate at 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor ONLY)

  24 months

• Constant-Murley Score

  Baseline, 6 months, 12 months, and 24 months

• American Shoulder and Elbow Surgeons (ASES) Score

  Baseline, 6 months, 12 months, and 24 months

• American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score

  Baseline, 6 months, 12 months, and 24 months

Study Arms (2)

HEALICOIL Knotless REGENESORB

HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB

Device: HEALICOIL Knotless REGENESORB

HEALICOIL Knotless PEEK

HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK

Device: HEALICOIL Knotless PEEK

Interventions

HEALICOIL Knotless PEEK DEVICE

HEALICOIL Knotless PEEK Self-Tapping HEALICOIL Knotless Non-Self Tapping

HEALICOIL Knotless PEEK

HEALICOIL Knotless REGENESORB DEVICE

HEALICOIL Knotless REGENESORB Self -Tapping HEALICOIL Knotless REGENSORB Non-Self Tapping

HEALICOIL Knotless REGENESORB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

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

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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

University of Stanford

Redwood City, California, 94063, United States

Location

Orthopaedic and Spine Center of Southern Colorado

Colorado Springs, Colorado, 80920, United States

Location

University of Colorado - Denver

Denver, Colorado, 80222, United States

Location

OrthoIllinois LTD

Rockford, Illinois, 61107, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

18008215700

Study Officials

• Karlie Morgan

  Smith & Nephew, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 17, 2020
• Study Start: January 26, 2021
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2024-11

Locations

US (5)