Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 300 subjects needing reattachment of soft tissue to bone.

Detailed Description
-----------------
The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors. Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 36 months.

Official Title
-----------------
Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB, Knotless REGENESORB and Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair

Conditions
-----------------
Labral Tear, Glenoid, Acetabular Labrum Tear, Bankart Lesions, Anterior Shoulder Instability, SLAP Lesion, Rotator Cuff Tears

Intervention / Treatment
-----------------
* Device: MICRORAPTOR™ REGENESORB™ Suture Anchor
* Device: MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor
* Device: MICRORAPTOR™ Knotless PEEK Suture Anchor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject requires reattachment of soft tissue to bone for the following indications: Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Rotator Cuff Repairs (knotless anchors only) Hip - Acetabular labrum repair/reconstruction Subject has consented to participate in the study by signing the EC-approved informed consent form. Subject is ≥18 years of age at time of surgery. Willing and able to make all required study visits. Able to follow instructions. Exclusion Criteria: Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation. Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture. Comminuted bone surface, which would compromise secure anchor fixation. Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing. The presence of infection. Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period. Currently using tobacco products (cigarette, smokeless tobacco, ecigarettes, vaping etc.). Concurrent bilateral surgery. Prior MICRORAPTOR REGENESORB, MICRORAPTOR Knotless REGENESORB, or MICRORAPTOR Knotless PEEK implantation. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study. Women who are pregnant or nursing. History of poor compliance with medical treatment. Prior ipsilateral surgeries performed on the joint space. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MICRORAPTOR™ REGENESORB™ Suture Anchor<br>MICRORAPTOR™ REGENESORB™ Suture Anchor | Device: MICRORAPTOR™ REGENESORB™ Suture Anchor<br>* Smith & Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone.<br>|
| MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor<br>MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | Device: MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor<br>* MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor is fixation device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (REGENESORB™), and a non-absorbable PEEK (Polyether ether ketone) distal anchor tip.<br>|
| MICRORAPTOR™ Knotless PEEK Suture Anchor<br>MICRORAPTOR™ Knotless PEEK Suture Anchor | Device: MICRORAPTOR™ Knotless PEEK Suture Anchor<br>* The MICRORAPTOR™ Knotless PEEK Suture Anchor is a class IIb device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (PEEK), and a non-absorbable PEEK distal anchor tip.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repair failure rate | To assess repair failure rate at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repair failure rate | To assess repair failure rate at 12 months | 12 months | 
| ROWE shoulder score | ROWE score for shoulder instability is a 3-item instrument completed by the investigator or qualified, delegated study staff. Its questions address the categories of shoulder stability (0 to 50 points), motion (0 to 20 points), and function (0 to 30 points). Scores range from 0 to 100 with a score of 90-100 points indicating an excellent evaluation, 75-89 points indicating a good evaluation, 51-74 points indicating a fair evaluation, and =< 50 points indicating a poor evaluation. | 6 and 12 months | 
| WOSI shoulder score | Western Ontario Shoulder Instability Index (WOSI) is a subject completed instrument. Its categories include physical symptoms (10 items), sports, recreation, work (4 items), pain (4 items), lifestyle (4 items), and emotion (3 items), with each category scored from 0 to 100 using a visual analog scale. Overall scores range from 0 to 2100 with a score of 0 indicating better shoulder function and 2100 indicating worse shoulder function. | 6 and 12 months | 
| Constant-Murley Shoulder Scale | 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. | 6 and 12 months | 
| HOS-ADL Score | Hip Outcome Score (HOS) was designed to assess the outcome of treatment intervention for individuals with acetabular tears who may be functioning throughout a wide range of abilities. It is a subject completed measure that consists of an Activities of Daily Living (ADL) subscale (17 scored items) and a Sports subscale (9 scored items) in which the response options are presented as 5-point Likert scales. Scores for each subscale range from 0% (least function) to 100% (most function). | 6 and 12 months | 
| Modified Harris Hip Score | Modified Harris Hip Score (mHHS) is a joint specific score that is completed by both the investigator or qualified, delegated study staff and the subject and consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0-4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worse disability) to 100 (less disability). | 6 and 12 months | 
| Adverse Events (AEs) | All adverse events (AEs) and complications occurring from the time of surgical implantation until study termination or study completion including intraoperative adverse events and complications will be collected and reported. | 12 months | 
| Anchor absorption/replacement by bone (Knotless Regenesorb only) | MRI performed to determine anchor absorption/replacement by bone at 6 months and 24 months | 6 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microraptor, suture anchor, knotless, Smith and Nephew