Monster Screw System Post-Market Clinical Follow-Up Study

NCT ID: NCT05190159

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-26

Study Completion Date

2022-09-21

Brief Summary

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

Detailed Description

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

Conditions

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Ankle Injuries Foot Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Monster Screw System

Monster Screw System

Intervention Type DEVICE

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

Interventions

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Monster Screw System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paragon 28

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacy Legue

Role: STUDY_DIRECTOR

Paragon 28

Locations

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Henry Ford Health Systems

Jackson, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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P20-SP-0001

Identifier Type: -

Identifier Source: org_study_id

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