Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Morphologic analysis of the proximal tibia after open wedge high tibial osteotomy for proper plate configuration
Acronym
Study hypothesis
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
Seoul National University Bundang Hospital IRB, 23/02/2015, ref: B-1502/286-104
Study design
Retrospective observational case series
Primary study design
Observational
Secondary study design
Case series
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
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
Phase
Drug names
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 trial start date
01/03/2014
Overall trial end date
23/05/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
From March 2012 to June 2014, 31 uni-planar and 38 bi-planar osteotomies were evaluated
Participant exclusion criteria
1. Two or three compartmental osteoarthritis
2. Rheumatoid arthritis
Recruitment start date
01/08/2014
Recruitment end date
01/01/2015
Locations
Countries of recruitment
Korea, South
Trial participating centre
Seoul National University Bundang Hospital
82 Gumi-ro 173(baekchilsipsam)beo
Bundang-gu
Seongnam-si
Gyeonggi-do
463-707
Korea, South
Sponsor information
Organisation
Seoul National University Bundang Hospital
Sponsor details
Department of Orthopaedic Surgery
Seoul National University College of Medicine
Bundang Hospital
166 Gumi-ro
Bundang-gu
Seongnam
463-707
Korea
South
+82 31 787 7199
smcos1@hanmail.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
31/05/2017
Participant level data
Stored in repository
Basic results (scientific)
Publication list