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Clinical Trial Summary

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.


Clinical Trial Description

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 80 subjects who have undergone soft tissue to bone fixation with the Monster Screw System. Data will be collected from the subjects' pre-op visits, intra-op visits, 6 week post-op follow-up visits (± 4 weeks), and final follow-up post-op follow-up visits (6 months ± 3 months). The subject must have adequate radiographic and medical records for the minimum follow up requirement appropriate to their indication for use. Prospective data collection will occur upon subject's provision of written informed consent, and data will be collected from patient reported outcome measures (PROM's). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05190159
Study type Observational
Source Paragon 28
Contact Caleigh Bates
Phone 3033041079
Email [email protected]
Status Not yet recruiting
Phase
Start date January 15, 2022
Completion date December 31, 2022

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