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

Completed

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

• Registration Number: NCT04893824
• Lead Sponsor: Paragon 28

Brief Summary

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

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 Timeline

• Study Start: 2021-04-19
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-20
• Status Verified: 2022-03
• Primary Completion: 2022-03-11
• Study Completion: 2022-03-25
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Orthopedic Foot and Ankle; 🇺🇸 Worthington, Ohio, United States