First Metatarsophalangeal Joint Arthritis
Conditions
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.
Interventions
DEVICEFlower Cube
single use, sterile disposable fixation construct
Sponsors
Flower Orthopedics
JEM Research Institute
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Union Rates | 12 months | Confirm union rates comparable to existing outcomes complications with our proposed construct. |
| Hardware Failures | 12 months | Evaluate hardware failures with our proposed construct. |
| Complications | 12 months | Evaluate complications with the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed