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OpenTrials
Completed

NCT Number: NCT05190874

Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

Completed

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Key information

Conditions

Ankle Injuries Achilles Tendon Rupture Ankle Inversion Sprain Ankle Sprains Deltoid Ankle Sprain Flexor Digitorum Longus on the Left Flexor Digitorum Longus on the Right Flexor Hallucis Longus on the Left Flexor Hallucis Longus on the Right Leg Injuries Syndesmotic Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopedic Foot and Ankle

Worthington, Ohio, 43085, United States

About this study

This is an ambispective, multi-surgeon, single site, consecutive case series taking place in the United States. Once a subject is identified and informed consent is obtained from that subject, retrospective data will be collected from the subject's electronic medical record (EMR), and prospective data will be collected from subject-provided PROM's. A minimum of 16 and maximum of 23 subjects will participate in the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject underwent a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques
  • The subject signs a written informed consent form (ICF)

Exclusion criteria

  • None

Treatment and study plan

Grappler Interference Screw System

Device

Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System

Primary outcomes

  1. Device performance and benefits as related to Foot and Ankle Mobility Measure

    Time frame: 6 months post-operative

    Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction.

  2. Device performance and benefits as related to pain levels based on the Visual Analog Scale

    Time frame: 6 months post-operative

    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)of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction.

  3. Device performance and benefits as related to pain levels based on Patient satisfaction

    Time frame: 6 months post-operative

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

Secondary outcomes

  1. Safety will be assessed by recording the incidence of secondary procedures related to the index device

    Time frame: 6 months post-operative

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

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
Apr 7, 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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