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

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-19

Study Completion Date

2022-03-25

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 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).

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

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 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