NCT00799370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 28, 2019

Status Verified

June 1, 2014

Enrollment Period

5.3 years

First QC Date

November 25, 2008

Last Update Submit

May 23, 2019

Conditions

Osteoarthritis, Knee

Keywords

OsteotomyWeight bearingOpening wedge

Outcome Measures

Primary Outcomes (1)

  • IKS score

    one year follow-up

Secondary Outcomes (4)

  • 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

Study Arms (2)

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

Early weight bearingPROCEDURE

Weight bearing performed immediately after surgery

1
Delayed weight bearingPROCEDURE

Weight bearing performed 2 months after surgery

2

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69002, France

Location

Related Publications (1)

  • 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.

    PMID: 27371292RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Elvire SERVIEN, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 27, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 28, 2019

Record last verified: 2014-06

Locations

FR(1)