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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-06-30

Brief Summary

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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?

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Detailed Description

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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?

Conditions

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Hallux Valgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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proximal open wedge osteotomy with LPS system

Proximal open wedge osteotomy with Low profile plate and screws

Group Type EXPERIMENTAL

proximal open wedge osteotomy with LPS system

Intervention Type PROCEDURE

proximal wedge osteotomy

Proximal wedge osteotomy procedure

Group Type ACTIVE_COMPARATOR

proximal chevron osteotomy

Intervention Type PROCEDURE

Interventions

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proximal chevron osteotomy

Intervention Type PROCEDURE

proximal open wedge osteotomy with LPS system

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes