Closing wedge high tibial osteotomy for unicompartmental knee osteoarthritis: staples and cast fixation versus TomoFix plate fixation - a randomised trial

ISRCTN	ISRCTN32133423
DOI	https://doi.org/10.1186/ISRCTN32133423
Protocol serial number	2; NTR483
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Not provided at time of registration

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 13/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr T M van Raaij
Scientific

Erasmus University Medical Centre
Department of Orthopaedic Surgery
P.O. Box 2040
Rotterdam
3000 CB
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	Closing HTO
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Arthritis, osteoarthritis
Intervention	Closing wedge high tibial osteotomy: staples and cast fixation versus TomoFix plate fixation.
Intervention type	Other
Primary outcome measure(s)	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.)
Key secondary outcome measure(s)	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
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	92
Key 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
Key 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
Date of first enrolment	01/08/2004
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus University Medical Centre

Rotterdam
3000 CB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes