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

Not Applicable

Completed

• Conditions: Hallux Valgus
• Interventions: Procedure: proximal open wedge osteotomy with LPS system; Procedure: proximal chevron osteotomy

• Registration Number: NCT01791634
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

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

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 Timeline

• Study Start: 2007-04
• Primary Completion: 2011-01
• Study Completion: 2012-06
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
proximal open wedge osteotomy with LPS system	proximal open wedge osteotomy with LPS system	Proximal open wedge osteotomy with Low profile plate and screws
proximal wedge osteotomy	proximal chevron osteotomy	Proximal wedge osteotomy procedure

Primary Outcome Measures

Name	Time	Method
Short Form 36	1 year

Trial Locations

Locations (1)

Halifax Infirmary; 🇨🇦 Halifax, Nova Scotia, Canada