Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.
NCT ID: NCT01797003
Last Updated: 2022-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2007-03-31
2017-01-31
Brief Summary
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Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.
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Detailed Description
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Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients.
In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Opening wedge HTO
Opening wedge high tibial osteotomy using Puddu plate
High tibial osteotomy
Closing wedge HTO
Closing wedge high tibial osteotomy using cramp fixation
High tibial osteotomy
Interventions
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High tibial osteotomy
Eligibility Criteria
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Inclusion Criteria
* Pain in medial compartment of the knee
* Correction angle of 5 degrees or more
Exclusion Criteria
* Rheumatoid arthritis or other similar disease
* Cancer
* Neurological disease
* Kidney disease or metabolic disease
30 Years
60 Years
ALL
No
Sponsors
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South-Eastern Norway Regional Health Authority
OTHER
Martina Hansen's Hospital
OTHER
Responsible Party
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Tor Kjetil Nerhus
Consultant Orthopaedic surgeon
Principal Investigators
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Tor Kjetil Nerhus, MD
Role: PRINCIPAL_INVESTIGATOR
Consultant orthopaedic surgeon
Locations
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Martina Hansens Hospital
Oslo, , Norway
Countries
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Other Identifiers
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TKN-003
Identifier Type: -
Identifier Source: org_study_id
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