Status:
COMPLETED
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
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 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, retrosp...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
January 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05190874
Start Date
January 14 2022
End Date
April 6 2022
Last Update
April 7 2022
Active Locations (1)
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1
Orthopedic Foot and Ankle
Worthington, Ohio, United States, 43085