Clinical trial NCT04552119: Safety of Treatment of Shoulder Repair
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff
Keywords: Rotator cuff
shoulder repair
HEALICOIL
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.

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.

Primary outcomes:
measure: Repair failure rate of HEALICOIL Knotless Suture Anchors
timeFrame: 6 months
Secondary outcomes:
measure: Repair failure rate at 12 months and 24 months
timeFrame: 12 and 24 months
measure: Constant-Murley Score
timeFrame: 6, 12, and 24 months
measure: American Shoulder and Elbow Surgeons (ASES) Visual Analog Scale (VAS) pain score
timeFrame: 6, 12, and 24 months
measure: Single Assessment Numeric Evaluation (SANE) Shoulder scale at 6 months and 12 months
timeFrame: 6 and 12 months
measure: EQ-5D-3L at 6 months and 12 months
timeFrame: 6 and 12 months
measure: Tendon thickening and anchor absorption/replacement by bone at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping
timeFrame: 6 and 24 months
measure: Tendon re-tear rate at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping only
timeFrame: 6 and 24 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: University of Stanford
state: California
city: Colorado Springs
country: United States
facility: Orthopaedic and Spine Center of Southern Colorado
state: Colorado
city: Denver
country: United States
facility: University of Colorado - Denver
state: Colorado
city: Rockford
country: United States
facility: OrthoIllinois LTD
state: Illinois
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
Study officials:
affiliation: Smith & Nephew, Inc.
name: Karlie Morgan
role: STUDY_CHAIR
References: