Randomized Control Trial on Postoperative Weight Bearing After High Tibial Osteotomy (HTO)

Hospices Civils de Lyon50 enrolled

Overview

The study analyzes the consequences of weight bearing after an HTO in a population of young patient with medial osteoarthritis (immediate weight bearing versus two month weight bearing). The two options are usually used so the protocol belongs to the intermediate care evaluation category. The IKS (International Knee Society) score at one year follow up is the first outcome. The aim of the study is to highlight that the option early weight bearing (immediately in postoperative) is equal to the option delayed weight bearing.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Early weight bearingPROCEDURE

Weight bearing performed immediately after surgery

Delayed weight bearingPROCEDURE

Weight bearing performed 2 months after surgery

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age: 40 to 65 years old * patients with medial osteoarthritis of knee of level 1 or 2 from ahlback's classification with High Tibial Osteotomy indication * one sided indication * well understanding of information note by patient, non-opposition to perform the research * Affiliation to a national health insurance program Exclusion Criteria: * age \< 40 or \> 65 years old * medial osteoarthritis of knee of level superior to 2 * bilatéral indication * patient opposition * non affiliation to a national health insurance program * law protected patients * pregnancy and breast feeding

Locations (1)

Hospices Civils de Lyon

Lyon, France

Outcomes

Primary Outcomes

IKS score

Time frame: one year follow-up

Secondary Outcomes

IKS score

Time frame: 6 months follow-up

VAS score of pain

Time frame: at D1, D5, D15, M1, M2, M3, M6 and one year follow-up

IKDC (International Knee Documentation Committee) score

Time frame: at M2, M, M6 and one year follow-up

Safety follow-up

Time frame: during the one year follow-up

Data from ClinicalTrials.gov

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