Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2; NTR483
Study information
Scientific title
Acronym
Closing HTO
Study hypothesis
Closing wedge osteotomy with plate fixation only will result in earlier mobilisation and better 1-year results considering pain and function then staple and cast fixation.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Arthritis, osteoarthritis
Intervention
Closing wedge high tibial osteotomy: staples and cast fixation versus TomoFix plate fixation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Is the accuracy of achieved correction of the mechanical limb axis post-operatively compared to the pre-operatively planned correction superior for closing wedge HTO with plate fixation?
Measurement:
Conservation of corrected angular limb deformity 1 year after surgery (success rate [%]). (Surgery is successful when the femoral-tibial axis 1 year after osteotomy is corrected accurately two degrees or less compared to the preoperative planned mechanical axis correction.)
Secondary outcome measures
1. Does the functional outcome differ between the two bone defect implants? Measurement:
1.1. Knee range of motion (ROM)
1.2. Pain score (Visual Analogue Scale)
1.3. Hospital for Special Surgery (HHS) Knee Service Rating System
1.4. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
1.5. Health-related quality-of-life score (EuroQol)
1.6. Complication
2. Which surgical technique is most efficient? Measurement: cost efficiency
Overall trial start date
01/08/2004
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients (male and female) with symptomatic medial osteoarthritis of the knee who are not indicated for a knee arthroplasty
2. Above 18 years of age
3. Patient is knowledgeable and able to understand the treatment consequences
4. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
92
Participant exclusion criteria
1. Mechanical axis not through the medial compartment (HipKneeAnkle angle greater than 180 degrees)
2. Rheumatoid arthritis
3. HipKneeAnkle angle less than 169 degrees
4. Range of motion (ROM) less than 100 degrees
5. Extension deficit 15 degrees
6. Collateral ligament insufficiency (instability grade 3)
7. Indication for a supracondylar femur osteotomy
8. Not able to speak or understand Dutch
Recruitment start date
01/08/2004
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus University Medical Centre
Rotterdam
3000 CB
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Dr. Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary