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Clinical Trials/NCT03290586
NCT03290586
Completed
Not Applicable

Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis; the Evaluation of a Novel, Single Use Sterile, Disposable Delivery System

JEM Research Institute1 site in 1 country69 target enrollmentFebruary 16, 2017
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ConditionsFirst Metatarsophalangeal Joint Arthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
First Metatarsophalangeal Joint Arthritis
Sponsor
JEM Research Institute
Enrollment
69
Locations
1
Primary Endpoint
Union Rates
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 16, 2017
End Date
April 3, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Levin

Principal Investigator

JEM Research Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Union Rates

Time Frame: 12 months

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

Hardware Failures

Time Frame: 12 months

Evaluate hardware failures with our proposed construct.

Complications

Time Frame: 12 months

Evaluate complications with the procedure

Secondary Outcomes

  • Cost Data(12 months)

Study Sites (1)

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