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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00799370
First received: November 25, 2008
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IKS score [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
  • VAS score of pain [ Time Frame: at D1, D5, D15, M1, M2, M3, M6 and one year follow-up ] [ Designated as safety issue: No ]
  • IKDC (International Knee Documentation Committee) score [ Time Frame: at M2, M, M6 and one year follow-up ] [ Designated as safety issue: No ]
  • Safety follow-up [ Time Frame: during the one year follow-up ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00799370     History of Changes
Other Study ID Numbers: 2007.477
Study First Received: November 25, 2008
Last Updated: June 25, 2014
Health Authority: France: Direction Générale de la Santé

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

ClinicalTrials.gov processed this record on July 23, 2014