Status:
COMPLETED
Grappler® Interference Screw Post-Market Clinical Follow-Up Study
Lead Sponsor:
Paragon 28
Conditions:
Ankle Injuries
Syndesmotic Injuries
Eligibility:
All Genders
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 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 wi...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
April 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04893824
Start Date
April 19 2021
End Date
March 25 2022
Last Update
November 15 2023
Active Locations (1)
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1
Orthopedic Foot and Ankle
Worthington, Ohio, United States, 43085