Status:
COMPLETED
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
Lead Sponsor:
Nova Scotia Health Authority
Collaborating Sponsors:
Arthrex, Inc.
Conditions:
Hallux Valgus
Eligibility:
All Genders
16+ years
Phase:
NA
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 angl...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01791634
Start Date
April 1 2007
End Date
June 1 2012
Last Update
July 19 2018
Active Locations (1)
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1
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7