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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-14

Study Completion Date

2022-04-06

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.

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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.

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Device: Grappler Interference Screw System

Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System

Grappler Interference Screw System

Intervention Type DEVICE

Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System

Interventions

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Grappler Interference Screw System

Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System

Intervention Type DEVICE

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)