Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
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 will be collected from the site's medical records for minimum of 50 subjects who have undergone soft tissue to bone fixation with the Grappler® Interference Screw System. Data will be collected from the subjects' pre-op visits, intra-op visits, 7 week post-op follow-up visits (± 4 weeks), and 6 month post-op follow-up visits (± 4 weeks). The subject must have adequate radiographic and medical records for the minimum follow up requirement of 6 months. Prospective data collection will occur upon subject's provision of written informed consent, and data will be collected from patient reported outcomes (PRO's).
Study Type
OBSERVATIONAL
Enrollment
50
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
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.
Time frame: 6 Months Post-Op
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.
Time frame: 6 Months Post-Op
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.
Time frame: 6 Months Post-Op
Rate of recurrence of deformity
Safety as related to rate of recurrence of deformity
Time frame: 7 Weeks Post-Op, 6 Months Post-Op
Rate of implant failure
Safety as related to rate of implant failure
Time frame: Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op
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
Time frame: 7 Weeks Post-Op, 6 Months Post-Op
Rate of screw removal
Safety as related to rate of screw removal
Time frame: 7 Weeks Post-Op, 6 Months Post-Op
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
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)
Time frame: 6 months post-operative
Patient satisfaction
Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)
Time frame: 6 months post-operative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.