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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05190159
Other study ID # P20-SP-0001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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