Trial Outcomes & Findings for Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair (NCT NCT03691298)

Participants were enrolled form 07 November 2018 to 21 May 2021.

Overall, 83 participants (42 hips / 41 shoulders) were enrolled and received the investigational product (IP) at 9 sites.

Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair

Number of participants without signs of failure and/or re-intervention as assessed by the surgeon.

Number of participants without signs of failure and/or re-intervention at 12 months, as assessed by the surgeon.

Number of suture anchors that were successfully deployed to bone, soft tissues, or both.

Suture anchor failures categorized by number of participants with: * Intra-operative failures (Yes/No) * Anchors pulled out (Yes/No) * Additional anchors used as a result of failure (Yes/No)

Number of participants with a device-related adverse event (AE) that required a re-intervention due to the device-related AE.

Assessed participant pain using Visual Analog Scale (VAS) assessments taken 6 and 12 months postoperative intervals. The VAS Pain Score was based on a scale of 0 to 10, with 0 representing no pain and 10 the worst possible pain. Note: This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.

Assessed participant satisfaction using a Visual Analog Scale (VAS) assessments taken at 6 and 12 month postoperative intervals. The VAS Subject Satisfaction Questionnaire was based on a scale of 0 to 10, with 0 representing very satisfied and 10 very unsatisfied. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.

The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.

The Hip Outcome Score Activities of Daily Living (HOOS-ADL) Score included 5 domains (Symptoms, Pain, Daily Living, Sport \& Recreation and Quality of Life) each assessed at 6 and 12 months postoperative. Each HOOS domain range was based on a scale of 0 to 100, where 0 represents extreme symptoms and 100 represents no symptoms.

The Modified Harris Hip Score (mHHS) is a measurement of dysfunction; the higher the score, the better the outcome. The mHHS score range was as follows: * \<70 (poor result) * 70-79 (fair result) * 80-89 (good result) * \>90 (excellent result) This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.

The Rowe Scores address categories of shoulder stability, motion, and function. Scores range from 0 to 100 with a score of 90 to 100 points indicating an excellent evaluation, 75 to 89 points indicating a good evaluation, 51 to 74 points indicating a fair evaluation, and 0 to 50 points indicating a poor evaluation. This Patient Reported Outcome (PRO) was optional and used according to the surgeon's preference.

The American Shoulder and Elbow Surgeons Score (ASES) was based on a scale of 0 to 100 points, where 0 indicated a worse shoulder condition and 100 indicated a better shoulder condition

The Constant-Murley Shoulder Score (CMS) was based on a scale of 0 to 100 points divided into 4 subscales; pain (15 points), Activities of Daily Living (20 points), strength (25 points), and Range of Motion, including: forward elevation, external rotation, abduction, and internal rotation (40 points). The higher the score, the higher the quality of the function (less disability).