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Completed

NCT Number: NCT05190159

Monster Screw System Post-Market Clinical Follow-Up Study

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

Completed

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Key information

Conditions

Ankle Injuries Foot Injuries Foot Injury Leg Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Health Systems

Jackson, Michigan, 49201, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monster Screw System

Device

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

Primary outcomes

  1. 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

  2. Incidence of adverse events

    Time frame: Up to 9 months

    Safety will be assessed by recording the incidence of adverse events

Secondary outcomes

  1. 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

  2. Rate of Maintenance of Correction

    Time frame: Up to 9 months

    Safety as related to the rate of the maintenance of correction

  3. Rate of Index Device Failure

    Time frame: Up to 9 months

    Safety as related to the rate of the failure of the index device

  4. 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.

  5. 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)

  6. Patient satisfaction

    Time frame: Up to 54 months

    Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)

Sponsors and collaborators

Lead sponsor

Paragon 28

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2022
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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