Safety of Treatment of Shoulder Repair

NCT ID: NCT04552119

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed Description

This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the HEALICOIL Knotless Suture Anchors in subjects with rotator cuff tendon repair. Approximately 160 subjects will be enrolled at up to 6 sites. Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative follow up, clinical complications, reoperation rate, EQ-5D-5L, and pain VAS.

Conditions

Rotator Cuff

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HEALICOIL Knotless Suture REGENESORB

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

HEALICOIL Knotless REGENESORB

Intervention Type: DEVICE

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

HEALICOIL Knotless PEEK

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

HEALICOIL Knotless PEEK

Intervention Type: DEVICE

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

Interventions

HEALICOIL Knotless PEEK

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

Intervention Type: DEVICE

HEALICOIL Knotless REGENESORB

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Requires reattachment of soft tissue to bone for the following shoulder indications:

1. 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

2. 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

2. Has a pre-operative standard of care MRI within 6 months of surgery containing the following sequences:

1. Sat T2 FS: Oblique Sag T2-weighted Fat Saturation Spin Echo (oriented perpendicular to the scapula), with TE > 70 ms, AND

2. Cor T2 FS: Oblique Cor T2-weighted Fat Saturation Spin Echo (oriented parallel to the scapula), with TE > 70 ms, AND

3. Sag T1: Oblique Sag T1-weighted Spin Echo (oriented perpendicular to the scapula); OR

4. Willing and able to undergo an additional study specific pre-operative MRI according to the study Imaging Protocol if the above criteria is not met OR

5. MRI not required; subject not in HEALICOIL RG NST subgroup

3. Has consented to participate in the study by signing the IRB/IEC approved informed consent form.

4. Requires only one variant of the HEALICOIL Knotless Suture Anchor

5. Is ≥18 years of age at time of surgery

6. Willing and able to make all required study visits

7. Able to follow instructions (Approved translated documents supplied upon request)

Exclusion Criteria

• Any one (1) of the following criteria will disqualify a potential subject from participation in the study:

1. Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.

2. Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.

3. Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.

4. Comminuted bone surface, which would compromise secure anchor fixation.

5. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing

6. The presence of infection.

7. Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.

8. Concurrent bilateral surgery.

9. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.

10. Women who are pregnant.

11. Prior ipsilateral surgeries performed on the joint space.

12. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karlie Morgan

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Locations

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

Countries

United States

Other Identifiers

HEALICOIL.KNOTLESS.2019.12

Identifier Type: -

Identifier Source: org_study_id