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 2023-11-15.
Sponsored by Paragon 28 (part of Zimmer Biomet) · Observational
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).
350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.
This study's enrollment of 50 is below the median of 84 across 73 observational studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →Paragon 28 is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
First submitted before Paragon 28 became part of Zimmer Biomet.
Counted across the registry records on this site, refreshed daily.
The investigational population will include a minimum of 50 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the Prospective Data Collection:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Mar 2022, 10 months.
Of 38 observational studies under Ankle Injuries, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's 10 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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