PMCF Study on PEEK Suture Anchors for Shoulder Indications

Completed

• 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

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-02-14
• Primary Completion: 2019-08-28
• Study Completion: 2019-08-28
• Results First Submitted: 2021-10-22
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-12
• Last Update Submitted: 2022-02-12
• Results First Posted: 2022-04-12
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

1. Subjects who have undergone shoulder joint repair using the study devices.
2. Subjects aged 18 years and older at the time of surgery.

Exclusion Criteria

1. Subjects who are < 12 months post-operative.
2. 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 shoulder
Visual 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)

Grandview Medical Center; 🇺🇸 Birmingham, Alabama, United States

OrthoArizona; 🇺🇸 Phoenix, Arizona, United States

University of Colorado- Denver; 🇺🇸 Denver, Colorado, United States

Holy Cross Hospital/Orthopedic Institute; 🇺🇸 Fort Lauderdale, Florida, United States

OrthoAtlanta; 🇺🇸 Lawrenceville, Georgia, United States

Community Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States

University Orthopedics Center; 🇺🇸 Altoona, Pennsylvania, United States

Houston Methodist at Baytown; 🇺🇸 Baytown, Texas, United States

Texas Orthopedic Hospital - Houston; 🇺🇸 Houston, Texas, United States

Aspen Orthopedics at New Berlin; 🇺🇸 New Berlin, Wisconsin, United States

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