Status:
COMPLETED
Multi-Plane Hallux Valgus Correction With the Phantom® Nail
Lead Sponsor:
Paragon 28
Conditions:
Arthrodesis
Bunion
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this research study is to determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint with the Phantom® Intramedullary Nail combi...
Detailed Description
Each subject will undergo a Lapidus Arthrodesis combined with a supinating reduction technique. The subjects will undergo 3 weight-bearing CBCT scans of their foot and ankle, one pre-arthrodesis, one...
Eligibility Criteria
Inclusion
- The subject is at least 18 years of age at the time of screening.
- The subject has been diagnosed with hallux valgus.
- The subject has pain associated with hallux valgus.
- The subject agrees to comply with the requirements of the study and complete the study measures.
- The subject is willing and able to provide written informed consent.
- The subject plans to undergo a Lapidus Arthrodesis procedure with a 3-Hole Phantom® Intramedullary Nail.
Exclusion
- The subject is pregnant.
- The subject has had previous surgery for hallux valgus on operative side.
- The subject will require a structural graft in the 1st TMT joint.
- The unshod foot in question is greater than 28 cm in length.
- The subject is not expected to complete the study according to the investigation plan.
- The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
- The subject is a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs, or anticipated to be non-compliant.
Key Trial Info
Start Date :
November 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04084262
Start Date
November 7 2019
End Date
May 9 2022
Last Update
September 23 2022
Active Locations (1)
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1
Orthopedic Center of Palm Beach County
Atlantis, Florida, United States, 33462