Safety of Treatment of Shoulder Repair (HEALICOIL_KNTL)

Prospective, Multi-Center, Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff
• Intervention / Treatment: Device: HEALICOIL Knotless REGENESORB; Device: HEALICOIL Knotless PEEK

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 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 (Actual): 138

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • University of Stanford
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Orthopaedic and Spine Center of Southern Colorado
    • Denver, Colorado, United States, 80222
      • University of Colorado - Denver
  • Illinois
    • Rockford, Illinois, United States, 61107
      • OrthoIllinois LTD
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • University Orthopedics Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HEALICOIL Knotless PEEK; HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK	Device: HEALICOIL Knotless PEEK; HEALICOIL Knotless PEEK Self-Tapping HEALICOIL Knotless Non-Self Tapping
HEALICOIL Knotless REGENESORB; HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB	Device: HEALICOIL Knotless REGENESORB; HEALICOIL Knotless REGENESORB Self -Tapping HEALICOIL Knotless REGENSORB Non-Self Tapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Clinical Success Rate at 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor ONLY)	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.	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).	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).	Baseline, 6 months, 12 months, and 24 months
American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain 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 VAS Pain score ranges from 0 to 10, where 0 represented no pain and 10 represented the worst pain (i.e., a lower score is a better outcome).	Baseline, 6 months, 12 months, and 24 months
Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months	The SANE is a simple, single-question, patient-based shoulder function assessment tool based on responses to the question ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?'' Scores ranged from 0 to 100, where 100 was considered normal (i.e., a better outcome).	Baseline, 6 months, 12 months, and 24 months
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score	The EuroQol EQ-5D-3L is composed of a descriptive system and EQ Visual Analogue Scale (EQ VAS). The descriptive system measures health-related Quality of Life (QOL) that consists of five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored based on one of the three levels of severity (e.g., no problems, some or moderate problems, extreme problems) to create a combined Index Score. The Index Score is reported on a scale of 0 to 1 with a higher score indicating better health.	Baseline, 6 months, 12 months, and 24 months
EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score	The EuroQol EQ-5D-3L is composed of the descriptive system and EQ Visual Analogue Scale (EQ VAS). The EQ VAS was the participants self-rated health scored on a scale of 0 to 100 with 0 indicating 'the worst health you can imagine' and 100 indicating 'the best health you can imagine' (i.e., a higher score is a better outcome).	Baseline, 6 months, 12 months, and 24 months
Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)	Magnetic Resonance Imaging (MRI) was used to determine tendon thickening in millimeters (mm) for the supraspinatus tendon at the Lateral Anterior, Lateral Posterior, Medial Anterior, and Medial Posterior locations at 6 months and 24 months. Lateral measurements were taken from the lateral end of the supraspinatus tendon, about 5mm to the bony insertion site. Medial measurements considered the medial end of the supraspinatus tendon, about 5mm lateral to the musculotendinous junction.	6 months and 24 months
Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)	Magnetic Resonance Imaging (MRI) was used to determine participant tendon Re-tear Status at 6 months and 24 months. Re-tear Status was categorized as either 'Absent' or 'Present' based on the Re-tear Type assessment. 'Absent' indicated a Re-tear Type graded as 'Intact', 'Low-grade Partial-Thickness Tear', or 'High-grade Partial-Thickness Tear'. 'Present' indicated a Re-tear Type graded as 'Full-Thickness Tear'.	6 months and 24 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Karlie Morgan, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Rotator cuff; shoulder repair; HEALICOIL
• Other Study ID Numbers: HEALICOIL.KNOTLESS.2019.12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No