Grappler® Interference Screw Post-Market Clinical Follow-Up Study

Status Completed

Clinical Trial Summary

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

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 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04893824
Study type	Observational
Source	Paragon 28
Contact
Status	Completed
Phase
Start date	April 19, 2021
Completion date	March 25, 2022

View Details

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