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Early Weight-Bearing After Lapidus Arthrodesis

NCT03257540 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2018-10-17

No results posted yet for this study

Summary

The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail.

The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing protocol will be non-inferior to union rates previously published for this procedure.

Conditions

  • Arthrodesis
  • Bunion
  • Hallux Valgus

Interventions

DEVICE

Small Bone Intramedullary Nail

Patients undergoing a Lapidus Arthrodesis procedure for hallux valgus correction who are receiving a Phantom Small Bone Intramedullary nail will begin weight-bearing at 2 weeks and follow a pre-determined post-operative protocol.

Sponsors & Collaborators

  • Paragon 28

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-08-31
Completion
2018-08-31
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 NCT03257540 on ClinicalTrials.gov