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

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ClinicalTrials.gov Identifier: NCT03290586
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Flower Orthopedics
Information provided by (Responsible Party):
John Levin, JEM Research Institute

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.

Condition or disease Intervention/treatment
First Metatarsophalangeal Joint Arthritis Device: Flower Cube

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

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


Primary Outcome Measures :
  1. Union Rates [ Time Frame: 12 months ]
    Confirm union rates comparable to existing outcomes complications with our proposed construct.

  2. Hardware Failures [ Time Frame: 12 months ]
    Evaluate hardware failures with our proposed construct.

  3. Complications [ Time Frame: 12 months ]
    Evaluate complications with the procedure


Secondary Outcome Measures :
  1. Cost Data [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290586


Contacts
Contact: John Levin, DPM 561-968-2933 mdaggerhart@jemri.net
Contact: Melissa Daggerhart, MBA 5619682933 mdaggerhart@jemri.net

Locations
United States, Florida
JEM Research Institute Recruiting
Atlantis, Florida, United States, 33462
Contact: John Levin, DPM    561-968-2933      
Contact: Melissa Daggerhart, MBA    561-968-2933      
Sponsors and Collaborators
JEM Research Institute
Flower Orthopedics
Investigators
Principal Investigator: John Levin, DPM JEM Research Institute

Responsible Party: John Levin, Principal Investigor, JEM Research Institute
ClinicalTrials.gov Identifier: NCT03290586     History of Changes
Other Study ID Numbers: FLO-001
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No