NCT04893824

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Paragon 28 · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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).

Conditions

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

Interventions

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

Timeline

• Start date: 2021-04-19
• Primary completion: 2022-03-11
• Completion: 2022-03-25
• First posted: 2021-05-20
• Last updated: 2023-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study