Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis

JEM Research Institute

Status: Completed

Conditions: First Metatarsophalangeal Joint Arthritis

Treatments: Device: Flower Cube

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03290586

FLO-001

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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