Randomized Control Trial on Postoperative Weight Bearing... | NCT00799370

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

NCT00799370

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

May 28, 2019Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Osteoarthritis, Knee

Interventions

Early weight bearing
Delayed weight bearing

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Nov 25, 2008

First Submission Date that Met QC Criteria

Nov 26, 2008

First Posted Date

Nov 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2019

Last Update Posted Date

May 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Early weight bearing: immediate in postoperative	Procedure: Early weight bearing
2	Experimental	Delayed weight bearing: 2 months after surgery	Procedure: Delayed weight bearing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early weight bearing	Procedure	Weight bearing performed immediately after surgery	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IKS score		one year follow-up

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elvire SERVIEN, MD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices Civils de Lyon		Lyon		69002	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27371292	Result	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.

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases