Monster Screw System Post-Market Clinical Follow-Up Study

Ankle Injuries Clinical Trial

Official title:

Monster Screw System Post-Market Clinical Follow-Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190159
• Other study ID #: P20-SP-0001
• Status: Completed
• Start date: January 26, 2022
• Est. completion date: September 21, 2022

Study information

• Verified date: September 2022
• Source: Paragon 28
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 21, 2022
• Est. primary completion date: September 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Foot Injuries
• Foot Injury
• Wounds and Injuries

Intervention

Device:
• Monster Screw System
Subjects who have undergone a foot and/or ankle procedure involving the index device

Locations

Country	Name	City	State
United States	Henry Ford Health Systems	Jackson	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Paragon 28

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of secondary procedures	Safety will be assessed by recording the incidence of secondary procedures related to the index procedure	Up to 9 months
Primary	Incidence of adverse events	Safety will be assessed by recording the incidence of adverse events	Up to 9 months
Secondary	Rate of Nonunion	Safety as related to the rate of nonunion of the area treated with the index device	Up to 9 months
Secondary	Rate of Maintenance of Correction	Safety as related to the rate of the maintenance of correction	Up to 9 months
Secondary	Rate of Index Device Failure	Safety as related to the rate of the failure of the index device	Up to 9 months
Secondary	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.	Up to 54 months
Secondary	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)	Up to 54 months
Secondary	Patient satisfaction	Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)	Up to 54 months