An observational study in Ankle Injuries, Syndesmotic Injuries and Ankle Inversion Sprain, sponsored by Paragon 28. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Paragon 28 · Observational
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.
The investigational population will include a minimum of 23 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
Exclusion Criteria:
Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System
Device: Grappler Interference Screw System
Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Paragon 28