Monster Screw System Post-Market Clinical Follow-Up Study

Completed

• Conditions: Ankle Injuries; Foot Injury
• Interventions: Device: Monster Screw System

• Registration Number: NCT05190159
• Lead Sponsor: Paragon 28

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.

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-13
• Study Start: 2022-01-26
• Status Verified: 2022-09
• Primary Completion: 2022-09-14
• Study Completion: 2022-09-21
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• 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 Criteria

-None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monster Screw System	Monster Screw System	-

Primary Outcome Measures

Name	Time	Method
Incidence of secondary procedures	Up to 9 months	Safety will be assessed by recording the incidence of secondary procedures related to the index procedure
Incidence of adverse events	Up to 9 months	Safety will be assessed by recording the incidence of adverse events

Secondary Outcome Measures

Name	Time	Method
Rate of Nonunion	Up to 9 months	Safety as related to the rate of nonunion of the area treated with the index device
Patient satisfaction	Up to 54 months	Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)
Rate of Index Device Failure	Up to 9 months	Safety as related to the rate of the failure of the index device
Rate of Maintenance of Correction	Up to 9 months	Safety as related to the rate of the maintenance of correction
Foot and Ankle Mobility Measure	Up to 54 months	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.
Visual Analog Scale	Up to 54 months	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)

Trial Locations

Locations (1)

Henry Ford Health Systems; 🇺🇸 Jackson, Michigan, United States