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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Delayed weight bearing; Procedure: Early weight bearing

• Registration Number: NCT00799370
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-11-27
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-06
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Delayed weight bearing	Delayed weight bearing: 2 months after surgery
1	Early weight bearing	Early weight bearing: immediate in postoperative

Primary Outcome Measures

Name	Time	Method
IKS score	one year follow-up

Secondary Outcome Measures

Name	Time	Method
IKS score	6 months follow-up
IKDC (International Knee Documentation Committee) score	at M2, M, M6 and one year follow-up
Safety follow-up	during the one year follow-up
VAS score of pain	at D1, D5, D15, M1, M2, M3, M6 and one year follow-up

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France