PMCF Study on PEEK Suture Anchors for Shoulder Indications
- Conditions
- Soft Tissue to Bone Fixation
- Registration Number
- NCT03826667
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 464
- Subjects who have undergone shoulder joint repair using the study devices.
- Subjects aged 18 years and older at the time of surgery.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention 6 months 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
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention 12 months 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 shoulderVisual Analog Scale (VAS) - Pain 6 and 12 months 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.
Count of Participants With Range of Motion (ROM) Full Functional Arc 6 and 12 months Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.
Range of Motion (ROM) 6 and 12 months Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.
Trial Locations
- Locations (11)
Holy Cross Hospital/Orthopedic Institute
🇺🇸Fort Lauderdale, Florida, United States
OrthoAtlanta
🇺🇸Lawrenceville, Georgia, United States
Houston Methodist at Baytown
🇺🇸Baytown, Texas, United States
Texas Orthopedic Hospital - Houston
🇺🇸Houston, Texas, United States
University Orthopedics Center
🇺🇸Altoona, Pennsylvania, United States
Aspen Orthopedics at West Allis
🇺🇸West Allis, Wisconsin, United States
Aspen Orthopedics at New Berlin
🇺🇸New Berlin, Wisconsin, United States
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
University of Colorado- Denver
🇺🇸Denver, Colorado, United States
Community Hospital
🇺🇸Oklahoma City, Oklahoma, United States
OrthoArizona
🇺🇸Phoenix, Arizona, United States