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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00426907 |
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Date of registration:
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23/01/2007 |
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Primary sponsor: |
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Public title:
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Weightbearing After High Tibial Osteotomy
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Scientific title:
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Weightbearing After Proximal Open-wedge Tibial Osteotomy - a Clinical, Randomized RSA-study. |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00426907 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Thomas Lind-Hansen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Orthopaedic Division, Northern Denmark Region |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed informed consent
- Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
- Varus deformity
Exclusion Criteria:
- Prednisolone treatment.
- NSAID treatment.
- BMI > or = 35.
- Previous surgery in lateral knee compartment.
- Secondary Arthrosis following fracture(s) of the tibial condyle(s).
- Lack of informed consent.
- Correction >12,5 mm
- Peroperative displaced fracture of lateral bony hinge.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Intervention(s)
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Procedure: Unlimited postoperative weightbearing
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Primary Outcome(s)
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Migration in mm measured with RSA (Roentgen Stereometric Analysis):
[Time Frame: Postoperative, at 3 month, 1 and 2 years.]
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Secondary Outcome(s)
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Bone Mineral Density (DEXA-scan) pre-op., Post.-op, at 6 weeks, 3 months and 1 and 2 years postop.
[Time Frame: Postoperative, at 3 month, 1 and 2 years.]
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Clinical scores including range of Movement and muscular status at 6 weeks, 3 month, 1 and 2 years postoperative.
[Time Frame: Postoperative, at 3 month, 1 and 2 years.]
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Hip-Knee-Ankle axis at 3 month, 1 and 2 years postoperative.
[Time Frame: Postoperative, at 3 month, 1 and 2 years.]
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Secondary ID(s)
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ON-04-016-TLH
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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