Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
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.
Study Type
OBSERVATIONAL
Enrollment
19
Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System
Orthopedic Foot and Ankle
Worthington, Ohio, United States
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.
Time frame: 6 months post-operative
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.
Time frame: 6 months post-operative
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)
Time frame: 6 months post-operative
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
Time frame: 6 months post-operative
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