ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00799370
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

November 25, 2008
November 27, 2008
June 26, 2014
November 2008
March 2014   (Final data collection date for primary outcome measure)
IKS score [ Time Frame: one year follow-up ]
Same as current
Complete list of historical versions of study NCT00799370 on ClinicalTrials.gov Archive Site
  • IKS score [ Time Frame: 6 months follow-up ]
  • VAS score of pain [ Time Frame: at D1, D5, D15, M1, M2, M3, M6 and one year follow-up ]
  • IKDC (International Knee Documentation Committee) score [ Time Frame: at M2, M, M6 and one year follow-up ]
  • Safety follow-up [ Time Frame: during the one year follow-up ]
Same as current
Not Provided
Not Provided
 
Randomized Control Trial on Postoperative Weight Bearing After High Tibial Osteotomy (HTO)
Prospective Study on Postoperative Weight Bearing After Opening Wedge High Tibial Osteotomy (HTO): Early Weight Bearing Versus Delayed. Open Labelled Randomized Clinical Study

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Osteoarthritis, Knee
  • Procedure: Early weight bearing
    Weight bearing performed immediately after surgery
  • Procedure: Delayed weight bearing
    Weight bearing performed 2 months after surgery
  • Experimental: 1
    Early weight bearing: immediate in postoperative
    Intervention: Procedure: Early weight bearing
  • Experimental: 2
    Delayed weight bearing: 2 months after surgery
    Intervention: Procedure: Delayed weight bearing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
136
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00799370
2007.477
No
Not Provided
Not Provided
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Elvire SERVIEN, MD Hospices Civils de Lyon
Hospices Civils de Lyon
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP