Total Hip Replacement Clinical Trial
Official title:
Evaluation of X-ray, Acetabular Guides and CT in THR
Total hip replacement is one of the most successful surgical procedures of modern times, with
over 80,000 performed each year in the UK. However, up to 5% of all primary hip replacements
need to be revised within the first 10 years, and in many cases malposition of the acetabular
(hip socket) component is implicated in the early failure.
The standard method of positioning the acetabular component is for the surgeon to be guided
by a combination of the visible anatomical landmarks within the surgical field, and the wider
environment of the operating theatre. The advent of 3D printing has led to the development of
custom-made surgical guides which can be used during surgery, in order to assist the surgeon
in the positioning of instruments and devices. These surgical guides are manufactured based
on CT or MRI imaging, and are designed to clearly indicate to the surgeon the desired
location and orientation of bony cuts and implant positions.
This study will test the hypothesis that an acetabular alignment guide combined with
three-dimensional CT-based planning using the Corin OPS™ (Optimised Positioning System),
provides more accurate component alignment following primary total hip replacement compared
with the current standard treatment, with the aim of improving patient outcomes and reducing
the risk of complications of total hip replacement.
Total hip replacement is one of the most successful surgical procedures of modern times, with
over 80,000 performed each year in the UK. The vast majority of patients experience dramatic
pain relief and improvement in function for many years. Despite this, however, there remains
a significant risk of complications, including dislocation, leg length discrepancy,
squeaking, and premature wear and failure of the implant. It is known that such complications
are more likely to occur if the acetabular component is incorrectly positioned during the
surgery. Up to 5% of all primary hip replacements need to be revised within the first 10
years, and in many cases malposition of the acetabular (hip socket) component is implicated
in the early failure.
The Corin OPS™ offers such a custom-made acetabular alignment guide. Prior to the patient's
surgery, a CT scan of the patient's pelvis & legs is performed, and the images are used to
produce a 3D computer model of the patient as they stand with a "virtual" hip replacement in
place. Four additional X-rays of the pelvis and lumbar spine are also taken, with the patient
adopting various predetermined "functional" positions (e.g. sitting in a chair, about to
stand up). From these X-rays, the changes in the pelvic and femoral orientations can be
measured for these functional positions. This data is then used to drive a simulation of the
movement of the 3D computer model. The orientation of the components of the virtual hip
replacement are then adjusted to optimise the biomechanical function of the joint. Once the
proposed implant positions have been reviewed and approved by the surgeon, a custom-made
acetabular orientation guide is 3-D printed and sterilised. During the surgery, this guide is
fitted into the patient's acetabulum prior to implanting the components. Using a simple
system of two sterile laser pointers, the orientation indicated by the guide can then be
reproduced when the definitive acetabular component is implanted. There is no published data,
however, on the accuracy of acetabular component positioning using this particular method.
The standard of care in the UK for acetabular component positioning is the "freehand
technique", where the surgeon is to be guided by a combination of the visible anatomical
landmarks within the surgical field, and the wider environment of the operating theatre. It
is important that the impact of this acetabular guide on acetabular component positioning be
assessed in order to determine whether this intervention is likely to improve patient
outcomes and reduce the risk of complications of total hip replacement.
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