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

This study has been completed.
Information provided by (Responsible Party):
Hospices Civils de Lyon Identifier:
First received: November 25, 2008
Last updated: June 25, 2014
Last verified: June 2014

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.

Condition Intervention
Osteoarthritis, Knee
Procedure: Early weight bearing
Procedure: Delayed weight bearing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • IKS score [ Time Frame: one year follow-up ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: November 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Early weight bearing: immediate in postoperative
Procedure: Early weight bearing
Weight bearing performed immediately after surgery
Experimental: 2
Delayed weight bearing: 2 months after surgery
Procedure: Delayed weight bearing
Weight bearing performed 2 months after surgery


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00799370

Hospices Civils de Lyon
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Elvire SERVIEN, MD Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon Identifier: NCT00799370     History of Changes
Other Study ID Numbers: 2007.477
Study First Received: November 25, 2008
Last Updated: June 25, 2014

Keywords provided by Hospices Civils de Lyon:
Weight bearing
Opening wedge

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 25, 2017