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OpenTrials
Completed

NCT Number: NCT03290586

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

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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Key information

Conditions

First Metatarsophalangeal Joint Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

JEM Research Institute

Atlantis, Florida, 33462, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flower Cube

Device

single use, sterile disposable fixation construct

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

JEM Research Institute

Industry

Collaborators

  • Flower Orthopedics

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2017
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.