Evaluation of X-ray, Acetabular Guides and CT in THR (EXACT)
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|ClinicalTrials.gov Identifier: NCT03072706|
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : November 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Total Hip Replacement||Device: Corin OPS™ Other: 2D X-ray templating technology||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-centre, patient-assessor blinded, parallel-group, randomised-controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The patient assessor will be blinded to the patients' group allocation|
|Primary Purpose:||Device Feasibility|
|Official Title:||Evaluation of X-ray, Acetabular Guides and CT in THR|
|Actual Study Start Date :||November 7, 2017|
|Estimated Primary Completion Date :||October 3, 2018|
|Estimated Study Completion Date :||October 3, 2019|
Active Comparator: Standard group
2D X-ray templating technology
Other: 2D X-ray templating technology
Standard care where hip replacement is planned using 2D X-ray templating software
Other Name: Standard Care
Experimental: Corin OPS™
Corin Optimised Positioning System (OPS) Dynamic Hip Analysis
Device: Corin OPS™
The OPS Dynamic Hip Analysis is a computer software package used to generate simulations of a total joint replacement from patient imaging. The dynamic simulation is used for operative planning, including implant selection, sizing and placement; and to create custom instruments or delivery specifications referencing the patient's anatomy and bio-mechanics. The simulation can also be used for the post-operative evaluation of joint performance.
- Acetabular cup anteversion angle [ Time Frame: 6 weeks (+/- 2 weeks) post-surgery ]The difference between planned and achieved acetabular cup anteversion assessed by post-operative CT scan
- Hip Disability & Osteoarthritis Outcome Score (HOOS) [ Time Frame: 6-weeks, 4- and 12-months post-surgery ]Hip Disability & Osteoarthritis Outcome Score (HOOS): a validated, patient-reported measure of hip function.
- Oxford Hip Score [ Time Frame: 6-weeks, 4- and 12-months post-surgery ]Oxford Hip Score: a validated, patient-reported measure of hip function
- EQ-5D [ Time Frame: 6-weeks, 4- and 12-months post-surgery ]EQ-5D: a standardised measure of health and economic outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072706
|Contact: Richard King, MBChB||02476 email@example.com|
|University Hospitals Coventry and Warwickshire||Recruiting|
|Coventry, West Midlands, United Kingdom, CV2 2DX|
|Contact: Richard King, MBChB 02476 965065 firstname.lastname@example.org|
|Principal Investigator:||Richard King, MBChB||University Hospitals Coventry and Warwickshire NHS Trust|