Prospective, Multi-Center Clinical Evaluation of the Open Wedge Osteotomy and Low Profile Plate & Screw (LPS) System Compared to the Proximal Chevron Osteotomy for the Treatment of Hallux Valgus With an Increased Intermetatarsal Angle (Hallux valgus)

July 18, 2018 updated by: Mark Glazebrook, Nova Scotia Health Authority

Prospective, Randomized, Multi-Center Clinical Evaluation of the Open Wedge Osteotomy and Low Profile Plate & Screw (LPS) System Compared to the Proximal Chevron Osteotomy for the Treatment of Hallux Valgus With an Increased Intermetatarsal Angle

Is there a difference in clinical outcome measures as assessed by the AOFAS, SF-36 and Visual Analogue Scale of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus the proximal chevron osteotomy?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Is there a difference in radiologic outcomes of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy? Is there a difference in surgical times or surgeon procedure preference in the treatment of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy? Is there a difference in complication rates of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy?

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Halifax Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age (> 16 years of age) moderate to severe hallux valgus angle [HVA] of >30º with increased intermetatarsal angles [IMA] of >13º
  • persistent incapacitating symptoms despite non-operative treatment (shoe wear modification, orthoses, non-steroidal anti-inflammatory drugs and restricted activity)

Exclusion Criteria:

  • degenerative arthritis of 1st metatarsophalangeal (MTP) joint
  • neuropathic patients
  • diabetes mellitus
  • peripheral vascular disease
  • previous 1st metatarsal, hallux or MTP joint surgery
  • active or recent foot/toe infection
  • currently participation in a another clinical trial
  • Worker's Compensation Board patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: proximal open wedge osteotomy with LPS system
Proximal open wedge osteotomy with Low profile plate and screws
Procedure: proximal open wedge osteotomy with LPS system
Active Comparator: proximal wedge osteotomy
Proximal wedge osteotomy procedure
Procedure: proximal chevron osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short Form 36
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Collaborators

Arthrex, Inc.

Investigators

  • Principal Investigator: Dr Mark A Glazebrook, MSc PhD Dip Sports Med MD,FRCS, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 12, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version1 Jan 4 2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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