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

Study Overview
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Brief Summary
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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

Official Title
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Safety and Performance of Q-Fix™ All-Suture Anchor System

Conditions
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Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, Bicep Tendinitis, Extra-capsular Repair, Medial Collateral Ligament, Lateal Collateral Ligament, Posterior Oblique Ligament, IBT, Vastus Medialis, Obliquus Advancement, Joint Capsule Closure

Intervention / Treatment
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* Device: The Q-Fix™ All-Suture Anchor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: The Q-Fix™ All-Suture Anchor|Observational, post-market, clinical follow-up study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Screening, 6 months, and 12 months | 
| Knee 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. | Screening, 6 months, and 12 months | 
| Shoulder 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. | Screening, 6 months, and 12 months | 
| Hip Range of Motion (ROM) | Full Range of Motion (ROM) defined as full functional arc in hip by the physician. | Screening, 6 months, and 12 months | 
| Knee Range of Motion (ROM) | Full Range of Motion (ROM) defined as full functional arc in knee by the physician | Screening, 6 months, and 12 months | 
| Shoulder Range of Motion (ROM) | Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician. | Screening, 6 months, and 12 months |