Safety of Treatment of Shoulder Repair (HEALICOIL_KNTL)

Smith & Nephew

Status: Completed

Conditions: Rotator Cuff

Treatments: Device: HEALICOIL Knotless PEEK; Device: HEALICOIL Knotless REGENESORB

Study type: Observational

Funder types: Industry

Identifiers

NCT04552119

HEALICOIL.KNOTLESS.2019.12

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

160 participants in 2 patient groups

HEALICOIL Knotless Suture REGENESORB

Description:

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

Treatment:

Device: HEALICOIL Knotless REGENESORB

HEALICOIL Knotless PEEK

Description:

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

Treatment:

Device: HEALICOIL Knotless PEEK