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 Clinical Trial

— Hallux valgus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791634
• Other study ID #: Version1 Jan 4 2007
• Status: Completed
• Phase: N/A
• Start date: April 2007
• Est. completion date: June 2012

Study information

• Verified date: July 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

Intervention

Procedure:
• proximal chevron osteotomy

• proximal open wedge osteotomy with LPS system

Locations

Country	Name	City	State
Canada	Halifax Infirmary	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Arthrex, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form 36		1 year