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

NCT ID: NCT00799370

Last Updated: 2019-05-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

Early weight bearing: immediate in postoperative

Group Type EXPERIMENTAL

Early weight bearing

Intervention Type PROCEDURE

Weight bearing performed immediately after surgery

2

Delayed weight bearing: 2 months after surgery

Group Type EXPERIMENTAL

Delayed weight bearing

Intervention Type PROCEDURE

Weight bearing performed 2 months after surgery

Interventions

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Early weight bearing

Weight bearing performed immediately after surgery

Intervention Type PROCEDURE

Delayed weight bearing

Weight bearing performed 2 months after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elvire SERVIEN, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

References

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Lansdaal JR, Mouton T, Wascher DC, Demey G, Lustig S, Neyret P, Servien E. Early weight bearing versus delayed weight bearing in medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Dec;25(12):3670-3678. doi: 10.1007/s00167-016-4225-8. Epub 2016 Jul 1.

Reference Type RESULT
PMID: 27371292 (View on PubMed)

Other Identifiers

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2007.477

Identifier Type: -

Identifier Source: org_study_id

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