PMCF Study on PEEK Suture Anchors for Shoulder Indications

Study Overview
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Brief Summary
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Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.

Official Title
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Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications

Conditions
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Soft Tissue to Bone Fixation

Intervention / Treatment
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* Device: Polyetheretherketone (PEEK) Shoulder Suture Anchors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have undergone shoulder joint repair using the study devices. Subjects aged 18 years and older at the time of surgery. Exclusion Criteria: Subjects who are < 12 months post-operative. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Polyetheretherketone (PEEK) Shoulder Suture Anchors|PEEK Suture Anchors, which include: HEALICOIL™ PK Preloaded Suture Anchors BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors BIORAPTOR™ Knotless Suture Anchors MULTIFIX™ S Ultra Knotless Fixation System FOOTPRINT™ Ultra PK Suture Anchors TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles SPEEDSCREW™ Knotless Fixation System SpeedLock Knotless Fixation Device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention | Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered Yes based on the following 3 main criteria: no inflammatory or allergic response no device-related adverse event (AE) no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention | Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered Yes based on the following 3 main criteria: no inflammatory or allergic response no device-related adverse event (AE) no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder | 12 months | 
| Visual Analog Scale (VAS) - Pain | The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery. | 6 and 12 months | 
| Count of Participants With Range of Motion (ROM) Full Functional Arc | Range of motion defined as the participant having a full functional arc Yes or No at 6 month and 12 month post-operative visits. | 6 and 12 months | 
| Range of Motion (ROM) | Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care. | 6 and 12 months |