Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures

Study Overview
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Brief Summary
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Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

Detailed Description
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This is an ambispective, multi-surgeon, single site, consecutive case series taking place in the United States. Once a subject is identified and informed consent is obtained from that subject, retrospective data will be collected from the subject's electronic medical record (EMR), and prospective data will be collected from subject-provided PROM's. A minimum of 16 and maximum of 23 subjects will participate in the study.

Official Title
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Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures

Conditions
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Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain, Achilles Tendon Rupture, Flexor Hallucis Longus on the Left, Flexor Hallucis Longus on the Right, Flexor Digitorum Longus on the Left, Flexor Digitorum Longus on the Right, Ankle Sprains

Intervention / Treatment
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* Device: Grappler Interference Screw System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject underwent a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques The subject signs a written informed consent form (ICF) Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Device: Grappler Interference Screw System<br>Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System | Device: Grappler Interference Screw System<br>* Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device performance and benefits as related to Foot and Ankle Mobility Measure | Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction. | 6 months post-operative | 
| Device performance and benefits as related to pain levels based on the Visual Analog Scale | Device performance and benefits as related to pain levels based on the Visual Analog Scale (range: 0 to 100; 0 = no pain; 100 = worst pain imaginable)of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction. | 6 months post-operative | 
| Device performance and benefits as related to pain levels based on Patient satisfaction | Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied) | 6 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by recording the incidence of secondary procedures related to the index device | Safety will be assessed by recording the incidence of secondary procedures related to the index device | 6 months post-operative |