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HEALICOIL_KNTL: Safety of Treatment of Shoulder Repair

Sponsor
Smith & Nephew, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04552119
Collaborator
(none)
160
Enrollment
6
Locations
44
Anticipated Duration (Months)
26.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: HEALICOIL Knotless PEEK
  • Device: HEALICOIL Knotless REGENESORB

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Dec 30, 2020
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
HEALICOIL Knotless Suture 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
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

Outcome Measures

Primary Outcome Measures

  1. Repair failure rate of HEALICOIL Knotless Suture Anchors [6 months]

    Repair failure rate defined as the need for a second repair procedure at 6 months.

Secondary Outcome Measures

  1. Repair failure rate at 12 months and 24 months [12 and 24 months]

    Repair failure rate is defined as the need for a second repair procedure. Repair rate at 24 months will be collected for the HEALICOIL Knotless REGENESORB Non-Self Tapping subgroup only.

  2. Constant-Murley Score [6, 12, and 24 months]

    Constant-Murley Shoulder (CMS) scale assesses four aspects related to shoulder pathology; two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65, resulting in a possible maximum total score of 100 points (best function). Pain and ADL are answered by the subject; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.

  3. American Shoulder and Elbow Surgeons (ASES) Visual Analog Scale (VAS) pain score [6, 12, and 24 months]

    The ASES instrument is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating with a higher score indicating improvement in pain and function. 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).

  4. Single Assessment Numeric Evaluation (SANE) Shoulder scale at 6 months and 12 months [6 and 12 months]

    The SANE is a simple, single-question, patient-based shoulder function assessment tool: ''How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?''

  5. EQ-5D-3L at 6 months and 12 months [6 and 12 months]

    The EuroQol EQ-5D-3L is a descriptive system measuring health-related Quality Of Life (QOL) and consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D-3L dimension.

  6. Tendon thickening and anchor absorption/replacement by bone at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping [6 and 24 months]

    Magnetic Resonance Imaging (MRI) will be used to determine tendon thickening and anchor absorption/replacement by bone at 6 and 24 months.

  7. Tendon re-tear rate at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping only [6 and 24 months]

    Magnetic Resonance Imaging (MRI) will be used to determine tendon re-tear rate at 6 months and 24 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

  2. Rotator Cuff Tendon repair

    1. Single or double row rotator cuff repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping; OR
    1. 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
  1. Biceps tenodesis
    1. 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
    1. 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

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

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

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

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

  5. 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

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

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

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

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

  10. Willing and able to make all required study visits

  11. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Stanford Redwood City California United States 94063
2 Orthopaedic and Spine Center of Southern Colorado Colorado Springs Colorado United States 80920
3 University of Colorado - Denver Denver Colorado United States 80222
4 OrthoIllinois LTD Rockford Illinois United States 61107
5 University Orthopedics Center Altoona Pennsylvania United States 16602
6 OrthoTennessee Knoxville Tennessee United States 37922

Sponsors and Collaborators

  • Smith & Nephew, Inc.

Investigators

  • Study Chair: Rob Bedford, Smith & Nephew, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT04552119
Other Study ID Numbers:
  • HEALICOIL.KNOTLESS.2019.12
First Posted:
Sep 17, 2020
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Smith & Nephew, Inc.
Rotator cuff
shoulder repair
HEALICOIL

Study Results

No Results Posted as of May 6, 2022