Safety of Treatment of Shoulder Repair

Smith & Nephew, Inc.138 enrolled

Overview

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

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 either rotator cuff repair and/or biceps tenodesis. 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.

Study Type

OBSERVATIONAL

Enrollment

138

Conditions

Rotator Cuff

Interventions

HEALICOIL Knotless PEEKDEVICE

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

HEALICOIL Knotless REGENESORBDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 MRI collected within 6 months of surgery which meets one of the following criteria: 1. MRI collected as standard-of-care has been submitted to external imaging vendor and confirmed as acceptable OR 2. 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 3. MRI not required; subject not in HEALICOIL Knotless 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.

Locations (5)

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

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Clinical Success Rate at 12 Months

Clinical success identified by the repair failure rate was 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.

Time frame: 12 months

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

Time frame: 24 months

Constant-Murley Score

Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology across four domains of pain, activities of daily living (ADL), range of motion (ROM), and strength. Pain and ADL are answered by the participant. ROM and strength require a physical evaluation and are answered by the surgeon or the physiotherapist. Scores range from 0 to 100, with a higher score indicating better shoulder function (i.e., a better outcome).

Time frame: Baseline, 6 months, 12 months, and 24 months

American Shoulder and Elbow Surgeons (ASES) Score

The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. It is based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). The ASES score ranges from 0 to 100 with a higher score indicating improvement in pain and function (i.e., a better outcome).

Data from ClinicalTrials.gov

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