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NCT05190874 Clinical Trial

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

Ankle Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05190874
Other study ID # P41-SP-0002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2022
Est. completion date April 6, 2022

Study information
Verified date April 2022
Source Paragon 28
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date April 6, 2022
Est. primary completion date March 11, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Orthopedic Foot and Ankle Worthington Ohio

Sponsors (1)
Lead Sponsor Collaborator
Paragon 28

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
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