NCT01791634

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

3.8 years

First QC Date

February 11, 2013

Last Update Submit

July 18, 2018

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

  • Short Form 36

    1 year

Study Arms (2)

proximal open wedge osteotomy with LPS system

EXPERIMENTAL

Proximal open wedge osteotomy with Low profile plate and screws

Procedure: proximal open wedge osteotomy with LPS system

proximal wedge osteotomy

ACTIVE COMPARATOR

Proximal wedge osteotomy procedure

Procedure: proximal chevron osteotomy

Interventions

proximal chevron osteotomyPROCEDURE
proximal wedge osteotomy
proximal open wedge osteotomy with LPS systemPROCEDURE
proximal open wedge osteotomy with LPS system

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Officials

  • Dr Mark A Glazebrook, MSc PhD Dip Sports Med MD,FRCS

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor,Dalhousie University Orthopedics

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 15, 2013

Study Start

April 1, 2007

Primary Completion

January 1, 2011

Study Completion

June 1, 2012

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

CA(1)