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.

Study Overview

• Status: Completed
• Conditions: Ankle Injuries; Achilles Tendon Rupture; Ankle Sprains; Syndesmotic Injuries; Ankle Inversion Sprain; Flexor Digitorum Longus on the Right; Flexor Digitorum Longus on the Left; Deltoid Ankle Sprain; Flexor Hallucis Longus on the Left; Flexor Hallucis Longus on the Right
• Intervention / Treatment: Device: Grappler Interference Screw System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Worthington, Ohio, United States, 43085
      • Orthopedic Foot and Ankle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigational population will include a minimum of 23 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Device: Grappler Interference Screw System; Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System	Device: Grappler Interference Screw System; Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device performance and benefits as related to Foot and Ankle Mobility Measure	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.	6 months post-operative
Device performance and benefits as related to pain levels based on the Visual Analog Scale	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.	6 months post-operative
Device performance and benefits as related to pain levels based on Patient satisfaction	Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)	6 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety will be assessed by recording the incidence of secondary procedures related to the index device	Safety will be assessed by recording the incidence of secondary procedures related to the index device	6 months post-operative

Collaborators and Investigators

• Sponsor: Paragon 28

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Rupture; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: P41-SP-0002

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.: No