Monster Screw System Post-Market Clinical Follow-Up Study

September 22, 2022 updated by: Paragon 28
Post-market clinical follow-up study on the Monster Screw System

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Jackson, Michigan, United States, 49201
        • Henry Ford Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The investigational population will include subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of secondary procedures
Time Frame: Up to 9 months
Safety will be assessed by recording the incidence of secondary procedures related to the index procedure
Up to 9 months
Incidence of adverse events
Time Frame: Up to 9 months
Safety will be assessed by recording the incidence of adverse events
Up to 9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paragon 28

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 26, 2022

Primary Completion (ACTUAL)

September 14, 2022

Study Completion (ACTUAL)

September 21, 2022

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (ACTUAL)

January 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-SP-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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