Status:
COMPLETED
Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis
Lead Sponsor:
JEM Research Institute
Collaborating Sponsors:
Flower Orthopedics
Conditions:
First Metatarsophalangeal Joint Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \\and hardw...
Eligibility Criteria
Inclusion
- Painful Hallux Limitus or Rigidus
- Painful Geriatric Hallux Valgus
- Failed prior 1st MTP joint arthroplasty (hemi-total)
- Arthritis of any etiology other than degenerative causes
Exclusion
- Age less than 18 years
- Pregnant Females
- Active or prior infection at the target joint
- Immunocompromised patients
- Patients unwilling to sign informed consent
- Patient's unwilling to participate the in study protocol
- Subject with known sensitivity to titanium implants
Key Trial Info
Start Date :
February 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 3 2018
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03290586
Start Date
February 16 2017
End Date
April 3 2018
Last Update
August 8 2019
Active Locations (1)
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1
JEM Research Institute
Atlantis, Florida, United States, 33462