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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
Sponsor:
Information provided by (Responsible Party):
University Hospitals Coventry and Warwickshire NHS Trust

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Oxford Hip Score [ Time Frame: 6-weeks, 4- and 12-months post-surgery ]
    Oxford Hip Score: a validated, patient-reported measure of hip function

  3. EQ-5D [ Time Frame: 6-weeks, 4- and 12-months post-surgery ]
    EQ-5D: a standardised measure of health and economic outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing an elective primary unilateral total hip replacement (THR) under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS Trust
  • Provision of written informed consent.
  • Male or Female aged 18-70 years.
  • Able and willing to comply with all study requirements.

Exclusion Criteria:

  • Those patients deemed by the treating clinician as unsuitable for an uncemented primary acetabular implant for reasons such as

    1. Low demand patient
    2. Osteoporosis
    3. Significant acetabular bone loss
  • Patients with significant orthopaedic deformities (eg fused knee, hip or ankle).
  • Unable to undergo planning imaging (unable to stand or sit for X-rays, or to lie in a CT scanner).
  • Patients currently receiving ionising radiation treatment or scans for other medical conditions.
  • Previous entry in this trial (contralateral THR).
  • Participation in a clinical trial of an investigational medicinal product in the last 90 days.

Information from the National Library of Medicine

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


Contacts
Contact: Richard King, MBChB 02476 965065 richard.king@uhcw.nhs.uk

Locations
United Kingdom
University Hospitals Coventry and Warwickshire Recruiting
Coventry, West Midlands, United Kingdom, CV2 2DX
Contact: Richard King, MBChB    02476 965065    richard.king@uhcw.nhs.uk   
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Investigators
Principal Investigator: Richard King, MBChB University Hospitals Coventry and Warwickshire NHS Trust

Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT03072706     History of Changes
Other Study ID Numbers: RK174116
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
hip replacement
acetabulum
anteversion
position
guide