NCT05190159

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

January 26, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

December 20, 2021

Last Update Submit

September 22, 2022

Conditions

Ankle InjuriesFoot Injury

Outcome Measures

Primary Outcomes (2)

  • Incidence of secondary procedures

    Safety will be assessed by recording the incidence of secondary procedures related to the index procedure

    Up to 9 months

  • Incidence of adverse events

    Safety will be assessed by recording the incidence of adverse events

    Up to 9 months

Secondary Outcomes (6)

  • Rate of Nonunion

    Up to 9 months

  • Rate of Maintenance of Correction

    Up to 9 months

  • Rate of Index Device Failure

    Up to 9 months

  • Foot and Ankle Mobility Measure

    Up to 54 months

  • Visual Analog Scale

    Up to 54 months

  • +1 more secondary outcomes

Study Arms (1)

Monster Screw System

Device: Monster Screw System

Interventions

Monster Screw SystemDEVICE

Subjects who have undergone a foot and/or ankle procedure involving the index device

Monster Screw System

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health Systems

Jackson, Michigan, 49201, United States

Location

MeSH Terms

Conditions

Ankle InjuriesFoot Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Jacy Legue

    Paragon 28

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 13, 2022

Study Start

January 26, 2022

Primary Completion

September 14, 2022

Study Completion

September 21, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)