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Total Hip ReplacementEXACTNCT03072706

Evaluation of X-ray, Acetabular Guides and CT in THR

A study testing Corin OPS™ and 2D X-ray templating technology in people with Total Hip Replacement, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Total Hip Replacement
What is being tested?
Corin OPS™ and 2D X-ray templating technology
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited Kingdom
Study dates
7 Nov 2017to 26 Jun 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Those patients deemed by the treating clinician as unsuitable for an uncemented primary acetabular implant for reasons such as
  • Low demand patient
  • Osteoporosis
  • 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).
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University Hospitals Coventry and Warwickshire

    Coventry, West Midlands, CV2 2DX

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
Corin OPS™, 2D X-ray templating technology
Keywords
hip replacement, acetabulum, anteversion, position, guide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Corin OPS™Device

    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.

  • 2D X-ray templating technologyOther

    Also called Standard Care

    Standard care where hip replacement is planned using 2D X-ray templating software

Study groups in NCT03072706
Study groupRoleWhat they receive
Standard groupActive comparator2D X-ray templating technology
Receives: Other: 2D X-ray templating technology
Corin OPS™ExperimentalCorin Optimised Positioning System (OPS) Dynamic Hip Analysis
Receives: Device: Corin OPS™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acetabular Cup Anteversion Angle

    The difference between planned and achieved acetabular cup anteversion assessed by post-operative CT scan

    Measured: 6 weeks (+/- 2 weeks) post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2017
  2. Study start7 Nov 2017
  3. Primary completion26 Jun 2020
  4. Study completion26 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-centre, patient-assessor blinded, parallel-group, randomised-controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03072706
Sponsor's protocol ID
RK174116
Acronym
EXACT
Status last verified
Feb 2026
First submitted
2 Mar 2017
Last updated
24 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be made available to other researchers

Questions about this trial

What is this clinical trial studying?

A study testing Corin OPS™ and 2D X-ray templating technology in people with Total Hip Replacement, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acetabular Cup Anteversion Angle (time frame: 6 weeks (+/- 2 weeks) post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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