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

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

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 Overview

• Status: Completed
• Conditions: First Metatarsophalangeal Joint Arthritis
• Intervention / Treatment: Device: Flower Cube

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the surgeons' private practices. These patients have already met the criteria for surgical intervention and have agreed to undergo the operative procedure and postoperative management.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Union Rates	Confirm union rates comparable to existing outcomes complications with our proposed construct.	12 months
Hardware Failures	Evaluate hardware failures with our proposed construct.	12 months
Complications	Evaluate complications with the procedure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: JEM Research Institute
• Collaborators: Flower Orthopedics
• Investigators: Principal Investigator: John Levin, DPM, JEM Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2017
• Primary Completion (Actual): April 3, 2018
• Study Completion (Actual): April 3, 2018

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: FLO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No