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

Completed

Conditions: Posterior Oblique Ligament
Acromioclavicular Sprain
Extra-capsular Repair
Lateal Collateral Ligament
IBT
SLAP Lesion
Capsular Shift/Capsulolabral Reconstruction
Deltoid Repair
Rotator Cuff Repair
Medial Collateral Ligament

Registration Number: NCT03594071

Lead Sponsor: Smith & Nephew, Inc.

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 294

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon	6 months	All individuals for whom the outcome of re-intervention is known at 6 months

Secondary Outcome Measures

Name	Time	Method
Hip Visual Analog Scale (VAS) - Pain	Screening, 6 months, and 12 months	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.
Shoulder Visual Analog Scale (VAS) - Pain	Screening, 6 months, and 12 months	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.
Shoulder Range of Motion (ROM)	Screening, 6 months, and 12 months	Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician.
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon	12 months	All individuals for whom the outcome of re-intervention is known at 12 months
Hip Range of Motion (ROM)	Screening, 6 months, and 12 months	Full Range of Motion (ROM) defined as full functional arc in hip by the physician.
Knee Range of Motion (ROM)	Screening, 6 months, and 12 months	Full Range of Motion (ROM) defined as full functional arc in knee by the physician
Knee Visual Analog Scale (VAS) - Pain	Screening, 6 months, and 12 months	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.

Trial Locations

Locations (5): The Orthopaedic Center- Center for Advanced Orthopaedics
🇺🇸
Washington, District of Columbia, United States
Northshore University Health System
🇺🇸
Chicago, Illinois, United States
Oklahoma Sports and Orthopedics Institute
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Oklahoma City, Oklahoma, United States
Tulane University Medical Center /Tulane Institute of Sport Medicine
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New Orleans, Louisiana, United States
Palmetto Health USC Orthopedic Center
🇺🇸
Columbia, South Carolina, United States