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

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Early weight bearing Procedure: Delayed weight bearing Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2008
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. IKS score [ Time Frame: 6 months follow-up ]
  2. VAS score of pain [ Time Frame: at D1, D5, D15, M1, M2, M3, M6 and one year follow-up ]
  3. IKDC (International Knee Documentation Committee) score [ Time Frame: at M2, M, M6 and one year follow-up ]
  4. Safety follow-up [ Time Frame: during the one year follow-up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799370


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

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00799370     History of Changes
Other Study ID Numbers: 2007.477
First Posted: November 27, 2008    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases