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

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Civil Hospices of Lyon

Status

Completed

Conditions

Osteoarthritis, Knee

Treatments

Procedure: Early weight bearing
Procedure: Delayed weight bearing

Study type

Interventional

Funder types

Other

Identifiers

NCT00799370
2007.477

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

1
Experimental group
Description:
Early weight bearing: immediate in postoperative
Treatment:
Procedure: Early weight bearing
2
Experimental group
Description:
Delayed weight bearing: 2 months after surgery
Treatment:
Procedure: Delayed weight bearing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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