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

NCT03072706 | Completed Results DMC

• 1 other identifier: RK174116
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacement

Keywords

hip replacement; acetabulum; anteversion; position; guide

Outcome Measures

Primary Outcomes (1)

• Acetabular Cup Anteversion Angle

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

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

Study Arms (2)

Standard group

ACTIVE COMPARATOR

2D X-ray templating technology

Other: 2D X-ray templating technology

Corin OPS™

EXPERIMENTAL

Corin Optimised Positioning System (OPS) Dynamic Hip Analysis

Device: Corin OPS™

Interventions

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.

Corin OPS™

2D X-ray templating technology OTHER

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

Also known as: Standard Care

Standard group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

University Hospitals Coventry and Warwickshire

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Professor Richard King
• Organization: University Hospitals Coventry and Warwickshire NHS Trust

richard.king@uhcw.nhs.uk

02476 965065

Study Officials

• Richard King, MBChB

  University Hospitals Coventry and Warwickshire NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patient assessor will be blinded to the patients' group allocation
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre, patient-assessor blinded, parallel-group, randomised-controlled trial

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 7, 2017
• Study Start: November 7, 2017
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)