Clinical Trials Directory

Trials / Completed

CompletedNCT01791634

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
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Nova Scotia Health Authority · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Accepted

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?

Conditions

Interventions

TypeNameDescription
PROCEDUREproximal chevron osteotomy
PROCEDUREproximal open wedge osteotomy with LPS system

Timeline

Start date
2007-04-01
Primary completion
2011-01-01
Completion
2012-06-01
First posted
2013-02-15
Last updated
2018-07-19

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01791634. Inclusion in this directory is not an endorsement.