Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00799370
NCT00799370
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country50 target enrollmentNovember 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsOsteoarthritis, Knee

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Hospices Civils de Lyon
Enrollment
50
Locations
1
Primary Endpoint
IKS score
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
March 2014
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

IKS score

Time Frame: one year follow-up

Secondary Outcomes

  • IKS score(6 months 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)
  • VAS score of pain(at D1, D5, D15, M1, M2, M3, M6 and one year follow-up)

Study Sites (1)

Loading locations...

Similar Trials

Terminated
Not Applicable
Trochanter Fixation Nail Advanced (TFNA) Weight BearingFemur Fracture
NCT03160508AO Innovation Translation Center16
Terminated
Not Applicable
Evaluation of Weight Bearing After Total Hip and Knee ReplacementArthropathy of HipArthropathy of Knee
NCT01135160Kantonsspital Münsterlingen100
Completed
Phase 4
Weightbearing After High Tibial OsteotomyOsteoarthritis, Knee
NCT00426907Northern Orthopaedic Division, Denmark20
Completed
Not Applicable
Effect of post-operative weight bearing status on clinical and radiological outcome of cementless femoral componentSurgery: Total hip replacementSurgeryTotal hip replacement
ISRCTN53323735Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)40
Recruiting
Not Applicable
Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle FracturesAnkle Fracture, BimalleolarAnkle Fracture, Trimalleolar
NCT05765929Ostfold Hospital Trust29