S&P of Q-Fix™ All-Suture Anchor System

Smith & Nephew, Inc.294 enrolled

Overview

Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements

Study Type

OBSERVATIONAL

Enrollment

294

Conditions

Bankart Lesion Acetabular Labrum Tear SLAP Lesion Acromioclavicular Sprain Capsular Shift/Capsulolabral Reconstruction Deltoid Repair Rotator Cuff Repair Bicep Tendinitis Extra-capsular Repair

Interventions

The Q-Fix™ All-Suture AnchorDEVICE

Observational, post-market, clinical follow-up study

Eligibility

Sex: ALLMin age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has undergone arthroscopic or open soft tissue repair with Q-Fix™ All-Suture Anchor System * Subject was ≥ 13 of age at time of surgery Exclusion Criteria: * Subject is ≤ 6 months post-operative * Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

Locations (5)

The Orthopaedic Center- Center for Advanced Orthopaedics

Washington D.C., District of Columbia, United States

Northshore University Health System

Chicago, Illinois, United States

Tulane University Medical Center /Tulane Institute of Sport Medicine

New Orleans, Louisiana, United States

Oklahoma Sports and Orthopedics Institute

Oklahoma City, Oklahoma, United States

Palmetto Health USC Orthopedic Center

Columbia, South Carolina, United States

Outcomes

Primary Outcomes

Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon

All individuals for whom the outcome of re-intervention is known at 6 months

Time frame: 6 months

Secondary Outcomes

Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon

All individuals for whom the outcome of re-intervention is known at 12 months

Time frame: 12 months

Hip Visual Analog Scale (VAS) - Pain

VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.