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 (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 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.
350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.
This study's enrollment of 19 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 23 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.
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
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.
Ran from Jan 2022 to primary completion in Mar 2022, 1 month.
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 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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