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Main
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Note: This record shows only 22 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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN76261748 |
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Date of registration:
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27/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Demineralised bone matrix (DBM) as an alternative for autogenous bone graft in high tibial valgus opening wedge osteotomy (HTO) for symptomatic medial compartmental knee osteoarthritis
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Scientific title:
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Date of first enrolment:
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01/10/2005 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN76261748 |
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Study type:
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Interventional |
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Study design:
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Multicentre, randomised active controlled factorial trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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T M
van Raaij |
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Address:
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Erasmus University Medical Centre
Department of Orthopaedic Surgery
P.O. Box 2040
3000 CB
Rotterdam
Netherlands |
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Telephone:
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Email:
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t.vanraaij@chello.nl |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male and female
2. Symptomatic medial osteoarthritis of the knee
3. Not indicated for a knee arthroplasty
4. Informed consent given
5. Baseline measurements are made
Exclusion criteria: 1. Below 18 years of age
2. Symptoms not related to medial osteoarthritis of the knee
3. Not able to speak or understand Dutch
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arthritis, osteoarthritis
Musculoskeletal Diseases
Polyarthrosis
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Intervention(s)
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A valgus high tibia opening wedge osteotomy will be performed and the osseous defect will be filled with DBM or autogenous bone graft.
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Primary Outcome(s)
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Conservation of corrected angular limb deformity one year after surgery (success rate [%]), (surgery is successful when the femoral-tibial axis one year after osteotomy is corrected accurately two degrees or less compared to the preoperative planned mechanical axis correction).
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Secondary Outcome(s)
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1. Knee range of motion (ROM)
2. Pain score (Visual Analogue Scale)
3. Hospital for Special Surgery (HHS) Knee Service Rating System
4. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
5. Health related quality-of-life score (EuroQol)
6. Donor site complication (only autogenous bone graft group)
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Secondary ID(s)
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1; NTR478
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Source(s) of Monetary Support
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Not provided at time of registration
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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