PMCF Study on PEEK Suture Anchors for Hip Indications

N/ACompletedNCT03814044

Smith & Nephew, Inc.149 enrolled

Overview

Post-market clinical follow-up (PMCF) on the PEEK Suture Anchors in the hip.

Study Type

OBSERVATIONAL

Enrollment

149

Conditions

Soft Tissue to Bone Fixation

Interventions

PEEK Suture AnchorsDEVICE

Subjects who have undergone hip joint repair using PEEK Suture Anchors: BIORAPTOR™ Knotless Suture Anchor and SpeedLock Hip Suture Anchor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects who have undergone hip joint repair using the study devices. 2. Subjects aged 18 years and older at the time of surgery. 3. Subjects who had a visit to their provider between 3 and 15 months postoperative. 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 3. Subject had off-label use of the PEEK suture anchor during surgery.

Locations (4)

DMOS Orthopedic Centers

West Des Moines, Iowa, United States

Center for Advanced Orthopedic and Sports Medicine

Auburn Hills, Michigan, United States

Community Hospital - Oklahoma City

Oklahoma City, Oklahoma, United States

Southwest Orthopaedic Reconstructive Specialists

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 6 Months After Intervention

Clinical success was defined as hip repairs without signs of device failure and/or re-intervention as assessed by the surgeon (Yes/No). Specifically, clinical success was achieved with "Yes" responses 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 (reintervention) on the index hip

Time frame: 6 months

Secondary Outcomes

Number of Participants With Clinical Success of the Study Devices in the Hip Over a Time Period of 12 Months After Intervention

Time frame: 12 months

Visual Analog Scale (VAS) - Pain

The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain and a score of 10 indicates extreme/unbearable pain. The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.

Time frame: 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.

Time frame: 6 months and 12 months

Range of Motion (ROM)

Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on the physician's Standard of Care.

Data from ClinicalTrials.gov

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