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

NCT05190874 | Completed FDA Device

• 1 other identifier: P41-SP-0002
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  6 months post-operative

Study Arms (1)

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

Interventions

Grappler Interference Screw System DEVICE

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

Device: Grappler Interference Screw System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Paragon 28: lead

Study Sites (1)

Orthopedic Foot and Ankle

Worthington, Ohio, 43085, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Jacy Legue

  Paragon 28

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: January 14, 2022
• Primary Completion: March 11, 2022
• Study Completion: April 6, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)