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)

Nova Scotia Health Authority (NSHA)

Status: Completed

Conditions: Hallux Valgus

Treatments: Procedure: proximal open wedge osteotomy with LPS system; Procedure: proximal chevron osteotomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01791634

Version1 Jan 4 2007

Details and patient eligibility

About

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?

Full 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?

Enrollment: 75 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

proximal open wedge osteotomy with LPS system

Experimental group

Description:

Proximal open wedge osteotomy with Low profile plate and screws

Treatment:

Procedure: proximal open wedge osteotomy with LPS system

proximal wedge osteotomy

Active Comparator group

Description:

Proximal wedge osteotomy procedure

Treatment:

Procedure: proximal chevron osteotomy