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

First Metatarsophalangeal Joint Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290586
• Other study ID #: FLO-001
• Status: Completed
• Start date: February 16, 2017
• Est. completion date: April 3, 2018

Study information

• Verified date: August 2019
• Source: JEM Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: April 3, 2018
• Est. primary completion date: April 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• First Metatarsophalangeal Joint Arthritis

Intervention

Device:
• Flower Cube
single use, sterile disposable fixation construct

Locations

Country	Name	City	State
United States	JEM Research Institute	Atlantis	Florida

Sponsors (2)

Lead Sponsor	Collaborator
JEM Research Institute	Flower Orthopedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Union Rates	Confirm union rates comparable to existing outcomes complications with our proposed construct.	12 months
Primary	Hardware Failures	Evaluate hardware failures with our proposed construct.	12 months
Primary	Complications	Evaluate complications with the procedure	12 months
Secondary	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.	12 months