Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis
Completed
- Conditions
- First Metatarsophalangeal Joint Arthritis
- Registration Number
- NCT03290586
- Lead Sponsor
- JEM Research Institute
- 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 hardware complications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hardware Failures 12 months Evaluate hardware failures with our proposed construct.
Union Rates 12 months Confirm union rates comparable to existing outcomes complications with our proposed construct.
Complications 12 months Evaluate complications with the procedure
- Secondary Outcome Measures
Name Time Method Cost Data 12 months Review cost data using the Flower Orthopedics single use, sterile disposable fixation construct performed in an outpatient surgical setting compared to in patient hospital setting.
Trial Locations
- Locations (1)
JEM Research Institute
🇺🇸Atlantis, Florida, United States