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

JEM Research Institute69 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

First Metatarsophalangeal Joint Arthritis

Interventions

Flower CubeDEVICE

single use, sterile disposable fixation construct

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

JEM Research Institute

Atlantis, Florida, United States

Outcomes

Primary Outcomes

Union Rates

Confirm union rates comparable to existing outcomes complications with our proposed construct.

Time frame: 12 months

Hardware Failures

Evaluate hardware failures with our proposed construct.

Time frame: 12 months

Complications

Evaluate complications with the procedure

Time frame: 12 months

Secondary Outcomes

Cost Data

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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