Proper plate configuration after open wedge high tibial osteotomy
| ISRCTN | ISRCTN97792440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97792440 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/05/2016
- Registration date
- 02/06/2016
- Last edited
- 30/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis (OA) is the most common type of arthritis and affects millions of people worldwide. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, causing stiffness, pain and a reduction in the range of movement. The knee is the most common joint to be affected by OA and in many sufferers, the pain prevents people from moving around leading to muscle weakness and disability. An open wedge high tibial osteotomy (OWHTO) is a type of procedure in which the proximal tibia (end of the shin bone) is cut and reshaped in order to relieve pressure on the knee joint. During this procedure, a wedge of bone is removed from the outside of the tibia, under the healthy side of the knee. When the surgeon closes the wedge it straightens the leg bringing the bones on the healthy side closer together, creating more space between the bones on the damaged side. This is then held in place with an artificial plate and screws. The aim of this study is to develop a new place that better fits the shape of the tibia after the procedure.
Who can participate?
Adult patients who have had an OWHTO to treat knee OA.
What does the study involve?
During this study, CT scans taken after the OWHTO procedure are used to create a 3D model of the proximal tibia and locking plate used. This is then reviewed in order to measure the different parts of the tibia in order to find out what the best shape for the locking plate would be.
What are the possible benefits and risks of participating?
There are no benefits or risks for participants in this study.
Where is the study run from?
Seoul National University Bundang Hospital (South Korea)
When is the study starting and how long is it expected to run for?
March 2014 to May 2015
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Youn Seuk Lee
Contact information
Scientific
Department of Orthopaedic Surgery
Seoul National University College of Medicine
Bundang Hospital, 166 Gumi-ro
Bundang-gu
Seongnam
463-707
Korea, South
Study information
| Study design | Retrospective observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| 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 | Morphologic analysis of the proximal tibia after open wedge high tibial osteotomy for proper plate configuration |
| Study objectives | The purpose of this study is to devise a new plate that best fit the post-contoured anatomy of the tibia by evaluating the surface geometry of the plate positioning site after an open wedge high tibial osteotomy (OWHTO). |
| Ethics approval(s) | Seoul National University Bundang Hospital IRB, 23/02/2015, ref: B-1502/286-104 |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | This study involved the retrospective evaluation postoperative CT scans taken for patients who underwent OWHTO using a locking plate were used for the reconstruction of the 3D model with Mimics v.16.0 (Materialise, Leuven, Belgium) of the proximal tibia and locking plate. Morphologic analysis of the proximal tibia was performed using the following parameters: 1. The radii in the axial plane were measured at the head and neck positions. The radii of the head were measured at 3 positions (Head_Top, Head_Mid, and Head_Bot) and those of the radii of the neck, at 2 positions (Neck_Top and Neck_Bot). The radii of the coronal plane were measured at 2 positions. 2. Two angles were measured at block insertion in the coronal plane: θ-1 was the angle between the contour line of the proximal fragment and the line connecting the end point of the proximal fragment and the end point of the distal fragment, and θ-2 was the angle between the contour line of the distal fragment and the line connecting the end point of the proximal fragment and the end point of the distal fragment. 3. Horizontal distance (Distance X) was measured between the end point of the proximal fragment and the end point of the distal fragment. The parameters were measured at 3 borders because the contours were underwent changes in the proximal fragment (head), gap (neck), and distal fragment (shaft). |
| Intervention type | Other |
| Primary outcome measure | Post-correction bone geometry is measured through a morphologic analysis of the proximal tibia. |
| Secondary outcome measures | No secondary outcome measures. |
| Overall study start date | 01/03/2014 |
| Completion date | 23/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | From March 2012 to June 2014, 31 uni-planar and 38 bi-planar osteotomies were evaluated |
| Total final enrolment | 69 |
| Key inclusion criteria | All patients who underwent an open wedge high tibial osteotomy (OWHTO) for the treatment of medial uni-compartmental osteoarthritis with a varus deformity. |
| Key exclusion criteria | 1. Two or three compartmental osteoarthritis 2. Rheumatoid arthritis |
| Date of first enrolment | 01/08/2014 |
| Date of final enrolment | 01/01/2015 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Bundang-gu
Seongnam-si
Gyeonggi-do
463-707
Korea, South
Sponsor information
Hospital/treatment centre
Department of Orthopaedic Surgery
Seoul National University College of Medicine
Bundang Hospital, 166 Gumi-ro
Bundang-gu
Seongnam
463-707
Korea, South
| Phone | +82 31 787 7199 |
|---|---|
| smcos1@hanmail.net | |
"ROR" |
https://ror.org/00cb3km46 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/05/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/10/2016 | 30/11/2020 | Yes | No |
Editorial Notes
30/11/2020: Publication reference and total final enrolment added.
11/08/2017: Internal review.
