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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

294 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-31

Study Completion Date

2019-12-11

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

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Detailed Description

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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The Q-Fix™ All-Suture Anchor

Observational, post-market, clinical follow-up study

Intervention Type DEVICE

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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes