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

Prospective Study on Postoperative Weight Bearing After Opening Wedge High Tibial Osteotomy (HTO): Early Weight Bearing Versus Delayed. Open Labelled Randomized Clinical Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00799370

Enrollment

Registered

2008-11-27

Start date

2008-11-30

Completion date

2014-03-31

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Osteotomy, Weight bearing, Opening wedge

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.

Interventions

PROCEDUREEarly weight bearing

Weight bearing performed immediately after surgery

PROCEDUREDelayed weight bearing

Weight bearing performed 2 months after surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
IKS score	one year follow-up

Secondary

Measure	Time frame
IKS score	6 months follow-up
VAS score of pain	at D1, D5, D15, M1, M2, M3, M6 and one year 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026