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

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Early weight bearing

Delayed weight bearing

About this trial

This is an interventional other trial for Osteoarthritis, Knee focused on measuring Osteotomy, Weight bearing, Opening wedge

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Early weight bearing: immediate in postoperative

Delayed weight bearing: 2 months after surgery

Outcomes

Primary Outcome Measures

IKS score

Secondary Outcome Measures

IKS score

VAS score of pain

IKDC (International Knee Documentation Committee) score

Safety follow-up

Full Information

NCT ID

NCT00799370

First Posted

November 25, 2008

Last Updated

May 23, 2019

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT00799370

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Osteotomy, Weight bearing, Opening wedge

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Early weight bearing: immediate in postoperative

Arm Title

Arm Type

Experimental

Arm Description

Delayed weight bearing: 2 months after surgery

Intervention Type

Procedure

Intervention Name(s)

Early weight bearing

Intervention Description

Weight bearing performed immediately after surgery

Intervention Type

Procedure

Intervention Name(s)

Delayed weight bearing

Intervention Description

Weight bearing performed 2 months after surgery

Primary Outcome Measure Information:

Title

IKS score

Time Frame

one year follow-up

Secondary Outcome Measure Information:

Title

IKS score

Time Frame

6 months follow-up

Title

VAS score of pain

Time Frame

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

Title

IKDC (International Knee Documentation Committee) score

Time Frame

at M2, M, M6 and one year follow-up

Title

Safety follow-up

Time Frame

during the one year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elvire SERVIEN, MD

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospices Civils de Lyon

City

Lyon

ZIP/Postal Code

69002

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

27371292

Citation

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.

Results Reference

result

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

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