An observational study in Ankle Injuries and Foot Injury, sponsored by Paragon 28. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Paragon 28 (part of Zimmer Biomet) · Observational
Post-market clinical follow-up study on the Monster Screw System
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.
350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.
This study's enrollment of 82 is close to 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 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:
-None
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.
Device: Monster Screw System
Subjects who have undergone a foot and/or ankle procedure involving the index device
Incidence of secondary procedures
Safety will be assessed by recording the incidence of secondary procedures related to the index procedure
Time frame: Up to 9 months
Incidence of adverse events
Safety will be assessed by recording the incidence of adverse events
Time frame: Up to 9 months
Rate of Nonunion
Safety as related to the rate of nonunion of the area treated with the index device
Time frame: Up to 9 months
Rate of Maintenance of Correction
Safety as related to the rate of the maintenance of correction
Time frame: Up to 9 months
Rate of Index Device Failure
Safety as related to the rate of the failure of the index device
Time frame: Up to 9 months
Foot and Ankle Mobility Measure
Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) subscale and current level of daily activity rating (0-100). The higher the score, the higher the level of function, with 100% representing no dysfunction.
Time frame: Up to 54 months
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: Up to 54 months
Patient satisfaction
Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)
Time frame: Up to 54 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Sep 2022, 7 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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