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 |
| Secondary identifying numbers | 2; NTR483 |
- 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
Scientific
Erasmus University Medical Centre
Department of Orthopaedic Surgery
P.O. Box 2040
Rotterdam
3000 CB
Netherlands
Study information
| Study design | Randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/08/2004 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
3000 CB
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Dr. Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/content/englishindex.htm |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
