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NCT Number: NCT00799370

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early weight bearing

Procedure

Weight bearing performed immediately after surgery

Delayed weight bearing

Procedure

Weight bearing performed 2 months after surgery

Primary outcomes

  1. IKS score

    Time frame: one year follow-up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2008
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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