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 Overview
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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?

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?

Official Title
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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

Conditions
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Hallux Valgus

Intervention / Treatment
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* Procedure: proximal chevron osteotomy
* Procedure: proximal open wedge osteotomy with LPS system


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 |  | 1 year |