Grappler® Interference Screw Post-Market Clinical Follow-Up Study

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 a ambispective, multi-surgeon, single site, consecutive case series. Data collection will occur in two phases. Retrospective data collection will occur upon subject identification, and data will be collected from the site's medical records for minimum of 50 subjects who have undergone soft tissue to bone fixation with the Grappler® Interference Screw System. Data will be collected from the subjects' pre-op visits, intra-op visits, 7 week post-op follow-up visits (± 4 weeks), and 6 month post-op follow-up visits (± 4 weeks). The subject must have adequate radiographic and medical records for the minimum follow up requirement of 6 months. Prospective data collection will occur upon subject's provision of written informed consent, and data will be collected from patient reported outcomes (PRO's).

Official Title
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Grappler® Interference Screw Post-Market Clinical Follow-Up Study

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 Digitorum Longus on the Left, Ankle Sprains, Flexor Hallucis Longus on the Right, Flexor Digitorum Longus on the Right

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 must have undergone 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 must have adequate radiographic and medical records for the minimum follow-up requirement of six months For the Prospective Data Collection: - The subject is willing to provide written informed consent Exclusion Criteria: None
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Grappler® Interference Screw System|Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of revisions | Safety will be assessed by recording the incidence of revisions. The relationship of events will be attributed to either the implant or instrumentation. | 6 Months Post-Op | 
| Incidence of adverse events | Safety will be assessed by recording the incidence of adverse events. The relationship of events will be attributed to either the implant or instrumentation. | 6 Months Post-Op | 
| Incidence of complications | Safety will be assessed by recording the incidence of complications. The relationship of events will be attributed to either the implant or instrumentation. | 6 Months Post-Op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence of deformity | Safety as related to rate of recurrence of deformity | 7 Weeks Post-Op, 6 Months Post-Op | 
| Rate of implant failure | Safety as related to rate of implant failure | Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op | 
| Rate of re-tear or re-rupture of fixated soft tissue | Safety as related to rate of re-tear or re-rupture of fixated soft tissue | 7 Weeks Post-Op, 6 Months Post-Op | 
| Rate of screw removal | Safety as related to rate of screw removal | 7 Weeks Post-Op, 6 Months Post-Op | 
| 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 | 
| 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) | 6 months post-operative | 
| Patient satisfaction | Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied) | 6 months post-operative |