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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-16

Study Completion Date

2018-04-03

Brief Summary

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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.

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Detailed Description

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Conditions

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First Metatarsophalangeal Joint Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Flower Cube

single use, sterile disposable fixation construct

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No