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

Completed

• Conditions: Flexor Digitorum Longus on the Left; Ankle Inversion Sprain; Deltoid Ankle Sprain; Ankle Sprains; Syndesmotic Injuries; Ankle Injuries; Achilles Tendon Rupture; Flexor Hallucis Longus on the Left; Flexor Digitorum Longus on the Right; Flexor Hallucis Longus on the Right
• Interventions: Device: Grappler Interference Screw System

• Registration Number: NCT05190874
• Lead Sponsor: Paragon 28

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-13
• Study Start: 2022-01-14
• Primary Completion: 2022-03-11
• Status Verified: 2022-04
• Study Completion: 2022-04-06
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device: Grappler Interference Screw System	Grappler Interference Screw System	Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System

Primary Outcome Measures

Name	Time	Method
Device performance and benefits as related to pain levels based on the Visual Analog Scale	6 months post-operative	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.
Device performance and benefits as related to pain levels based on Patient satisfaction	6 months post-operative	Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)
Device performance and benefits as related to Foot and Ankle Mobility Measure	6 months post-operative	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.

Secondary Outcome Measures

Name	Time	Method
Safety will be assessed by recording the incidence of secondary procedures related to the index device	6 months post-operative	Safety will be assessed by recording the incidence of secondary procedures related to the index device

Trial Locations

Locations (1)

Orthopedic Foot and Ankle; 🇺🇸 Worthington, Ohio, United States