Ankle Injuries Clinical Trial
Official title:
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
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 |
Verified date | April 2022 |
Source | Paragon 28 |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Orthopedic Foot and Ankle | Worthington | Ohio |
Lead Sponsor | Collaborator |
---|---|
Paragon 28 |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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