Status:

COMPLETED

Monster Screw System Post-Market Clinical Follow-Up Study

Lead Sponsor:

Paragon 28

Conditions:

Ankle Injuries

Foot Injury

Eligibility:

All Genders

Brief Summary

Post-market clinical follow-up study on the Monster Screw System

Detailed Description

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

Eligibility Criteria

Inclusion

  • The subject has undergone a foot and/or ankle procedure using the Monster Screw System and completed by one of the investigators.
  • The subject has adequate radiographic and medical records
  • For the Prospective Data Collection:
  • \- The subject is willing to provide written informed consent

Exclusion

  • None

Key Trial Info

Start Date :

January 26 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 21 2022

Estimated Enrollment :

82 Patients enrolled

Trial Details

Trial ID

NCT05190159

Start Date

January 26 2022

End Date

September 21 2022

Last Update

September 23 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Henry Ford Health Systems

Jackson, Michigan, United States, 49201