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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01791634

Acronym

Hallux valgus

Enrollment

Registered

2013-02-15

Start date

2007-04-30

Completion date

2012-06-30

Last updated

2018-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus

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?

Interventions

PROCEDUREproximal chevron osteotomy

PROCEDUREproximal open wedge osteotomy with LPS system

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Short Form 36	1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026