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

NCT04893824 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-11-15

No results posted yet for this study

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 Digitorum Longus on the Left
  • Ankle Sprains
  • Flexor Hallucis Longus on the Right
  • Flexor Digitorum Longus on the Right

Interventions

DEVICE

Grappler® Interference Screw System

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

Sponsors & Collaborators

  • Paragon 28

    lead INDUSTRY

Principal Investigators

  • Jacy Legue · Paragon 28

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2022-03-11
Completion
2022-03-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04893824 on ClinicalTrials.gov