Ankle Injuries Clinical Trial
Official title:
Grappler® Interference Screw Post-Market Clinical Follow-Up Study
NCT number | NCT04893824 |
Other study ID # | P41-SP-0001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 19, 2021 |
Est. completion date | March 25, 2022 |
Verified date | March 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 | 50 |
Est. completion date | March 25, 2022 |
Est. primary completion date | March 11, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | 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 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 | Incidence of revisions | Safety will be assessed by recording the incidence of revisions. The relationship of events will be attributed to either the implant or instrumentation. | 6 Months Post-Op | |
Primary | Incidence of adverse events | Safety will be assessed by recording the incidence of adverse events. The relationship of events will be attributed to either the implant or instrumentation. | 6 Months Post-Op | |
Primary | Incidence of complications | Safety will be assessed by recording the incidence of complications. The relationship of events will be attributed to either the implant or instrumentation. | 6 Months Post-Op | |
Secondary | Rate of recurrence of deformity | Safety as related to rate of recurrence of deformity | 7 Weeks Post-Op, 6 Months Post-Op | |
Secondary | Rate of implant failure | Safety as related to rate of implant failure | Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op | |
Secondary | Rate of re-tear or re-rupture of fixated soft tissue | Safety as related to rate of re-tear or re-rupture of fixated soft tissue | 7 Weeks Post-Op, 6 Months Post-Op | |
Secondary | Rate of screw removal | Safety as related to rate of screw removal | 7 Weeks Post-Op, 6 Months Post-Op | |
Secondary | 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 | |
Secondary | 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) | 6 months post-operative | |
Secondary | Patient satisfaction | Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied) | 6 months post-operative |
Status | Clinical Trial | Phase | |
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