Condition category
Musculoskeletal Diseases
Date applied
18/05/2016
Date assigned
02/06/2016
Last edited
02/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Yong Seuk Lee

ORCID ID

Contact details

Department of Orthopaedic Surgery
Seoul National University College of Medicine
Bundang Hospital
166 Gumi-ro
Bundang-gu
Seongnam
463-707
Korea
South

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 measures

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

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

Not Specified

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes