Grappler® Interference Screw Post-Market Clinical Follow-Up Study

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 a ambispective, multi-surgeon, single site, consecutive case series. Data collection will occur in two phases. Retrospective data collection will occur upon subject identification, and data will be collected from the site's medical records for minimum of 50 subjects who have undergone soft tissue to bone fixation with the Grappler® Interference Screw System. Data will be collected from the subjects' pre-op visits, intra-op visits, 7 week post-op follow-up visits (± 4 weeks), and 6 month post-op follow-up visits (± 4 weeks). The subject must have adequate radiographic and medical records for the minimum follow up requirement of 6 months. Prospective data collection will occur upon subject's provision of written informed consent, and data will be collected from patient reported outcomes (PRO's).

• Study Type: Observational
• Enrollment (Actual): 50

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: N/A

• Sampling Method: Non-Probability Sample

Study Population

The investigational population will include a minimum of 50 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria

Description

Inclusion Criteria:

• The subject must have undergone 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 must have adequate radiographic and medical records for the minimum follow-up requirement of six months

For the Prospective Data Collection:

- The subject is willing to provide written informed consent

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of revisions	Safety will be assessed by recording the incidence of revisions. The relationship of events will be attributed to either the implant or instrumentation.	6 Months Post-Op
Incidence of adverse events	Safety will be assessed by recording the incidence of adverse events. The relationship of events will be attributed to either the implant or instrumentation.	6 Months Post-Op
Incidence of complications	Safety will be assessed by recording the incidence of complications. The relationship of events will be attributed to either the implant or instrumentation.	6 Months Post-Op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrence of deformity	Safety as related to rate of recurrence of deformity	7 Weeks Post-Op, 6 Months Post-Op
Rate of implant failure	Safety as related to rate of implant failure	Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op
Rate of re-tear or re-rupture of fixated soft tissue	Safety as related to rate of re-tear or re-rupture of fixated soft tissue	7 Weeks Post-Op, 6 Months Post-Op
Rate of screw removal	Safety as related to rate of screw removal	7 Weeks Post-Op, 6 Months Post-Op
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
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)	6 months post-operative
Patient satisfaction	Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)	6 months post-operative

Collaborators and Investigators

• Sponsor: Paragon 28
• Investigators: Study Director: Jacy Legue, Paragon 28

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 25, 2022

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: March 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-0001

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.: Yes