The Hip Arthroplasty Positioning Improvement Study (HAPI)

Does the Corin Optimised Positioning System Improve Clinical Outcome in Total Hip Arthroplasty? A Multi-centre, Two-arm Randomised Control Trial

The primary objective of this study is to determine whether the Corin Optimised Positioning System (Corin, U.K.) reduces the rate of hip dislocation at one-year post-operatively compared with standard templating in patients undergoing total hip replacement.

The secondary objectives of this study are to determine whether the Corin Optimised Positioning System (Corin, U.K.) improves functional outcomes, reduces length of hospital stay, and reduces leg length discrepancy compared with standard templating in patients undergoing total hip replacement.

Study Overview

• Status: Unknown
• Conditions: Arthritis; Osteoarthritis; Osteoarthritis, Hip; Musculoskeletal Diseases or Conditions
• Intervention / Treatment: Procedure: Corin Optimised Positioning System; Procedure: Standard templating

Detailed Description

Osteoarthritis (OA) is the most common joint disease worldwide affecting an estimated 10% of males and 18% of females over 60 years of age. The resultant pain and loss of function can be debilitating and in developed countries represents a large socioeconomic burden, costing between 1% and 2.5% of gross domestic product, which currently stands at over £1.5 trillion. Total hip replacement (THR) is an effective treatment for end-stage hip arthritis; however, demand for the procedure is growing rapidly, fuelled by an ageing population and the obesity epidemic. In fact, rates of THR are predicted to rise 174% between 2005 and 2030. The current commissioning environment in developed countries means that investment in iterative improvements of existing THR implant designs are unlikely to yield either significant benefits to patients or be supported by health funders. The two principle issues that concern surgeons and patients are the longevity of implants and the ability of new technologies to minimise complications such as dislocation and infection. The James-Lind Priorities Setting Partnership, an internationally recognised patient-driven organisation, has recently identified these pre-operative and intra-operative factors as targets for improving outcome following hip and knee replacement.

One of the largest costs to healthcare providers following THR is dislocation. Although the dislocation rate reported in Joint Registries is between 1 and 3% we know that this significantly underestimates the true problem, as the majority of dislocation events are managed with closed reduction and do not result in revision surgery. It is estimated that dislocation is an order of magnitude more common than reported in Registry data. Literature estimates indicate a true dislocation prevalence of 3 to 15%. The cost of dislocation is significant as the problem is often recurrent, resulting in multiple hospital admissions. The resulting average cost for each patient who suffers a THR dislocation is around £30,000.

The factors that influence dislocation are poorly understood. Conventional surgical wisdom dictates that placing a cup in the Lewinneck 'safe zone' reduces both instability and wear. A recent study of 9784 primary THRs, however, demonstrated that 58% of patients who suffered a dislocation had implants judged to be in a safe position. This has led to suggestions that the idea of one generic 'safe zone' may be misleading; instead, there is a unique optimum position to place a cup in each patient undergoing THR, based on the unique and complex interaction of the spine and pelvis of the individual. Thus, in some patients, whilst the acetabular cup appears well positioned by conventional measures, pelvic tilt and spinal position mean that the cup is placed in a position of instability during some activities.

The Corin Optimised Positioning System (OPS) is a novel platform, designed to enable delivery of the prosthetic acetabular cup into an optimised position for every patient undergoing THR. It comprises two stages: pre-operative planning and intra-operative guidance. Pre-operatively, patients undergo dynamic imaging (computed tomography scanning and X-ray films). The information gained about the relative movements of a patient's spine, pelvis and hips are used to create a personalized physiological profile. This enables calculation of the optimized acetabular cup orientation for each individual. A unique physical guide (which falls under the definition of a custom-made device in the Medical Device Directive) is then created for each patient to fit precisely into the acetabular fossa, for use intra-operatively. Intra-operatively, the Corin OPS uses laser alignment to aid the surgeon in aligning the acetabular cup in the calculated optimised orientation. One laser is affixed to an immovable pelvic screw; the other is attached to the reverse of the acetabular cup. The target orientation of the cup is achieved when the two lasers are aligned.

The aim of this trial is to assess the efficacy of the use of the Corin Optimised Positioning System in reducing post-operative hip dislocation in patients undergoing total hip arthroplasty by comparing it with current standard templating in total hip arthroplasty. All total hip implants/components used in the study will be produced by Corin for uniformity and have the required approvals. There is currently no evidence that this novel approach to templating has an effect on dislocation rate. This project aims to provide evidence that this new technique can improve outcomes for patients and have the potential to reduce the need for complex, expensive revision surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marian Montgomery; Phone Number: +44 1865 737262; Email: hapi@ndorms.ox.ac.uk
• Study Contact Backup: Name: Pam Lovegrove; Phone Number: +44 1865 227803; Email: pam.lovegrove@ndorms.ox.ac.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 7LD
    • Recruiting
    • Nuffield Orthopaedic Centre, Oxford University Hospitals Trust
    • Contact: Marian Montgomery; Phone Number: +44 1865 737262; Email: hapi@ndorms.ox.ac.uk
    • Contact: Pam Lovegrove; Phone Number: +44 1865 227803; Email: pam.lovegrove@ndorms.ox.ac.uk
    • Principal Investigator: Sion Glyn-Jones, FRCS DPhil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the trial
• Diagnosed with hip OA, post-traumatic OA, inflammatory arthropathy, avascular necrosis, or congenital or developmental hip disease, avascular necrosis of the hip
• Listed for total hip arthroplasty at one of participating centres
• Participant is fit to undergo total hip arthroplasty based on consultant anaesthetist review
• In the Investigator's opinion, is able and willing to comply with all trial requirements
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial
• Female participants of child bearing potential must be willing to ensure that they use effective contraception during the trial

Exclusion Criteria:

• Inability to provide informed consent
• Previous surgery to the ipsilateral hip
• Significant co-morbidities that would make follow up difficult or uncomfortable
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corin OPS arm; Total hip replacement with use of Corin Optimised Positioning System to guide implant positioning	Procedure: Corin Optimised Positioning System; Total hip replacement with implant positioning guided by Corin Optimised Positioning System. The experimental and active comparator arms will use the same implants for total hip replacements. The Corin Trinity shell system will be used for the acetabular system. The Corin MiniHip, TriFit, MetaFix and TaperFit implants will be used for the femoral stem implant. Surgeons will select the implant most appropriate for each patient.; Other Names: K171847
Active Comparator: Standard care arm; Total hip replacement with standard templating to guide implant positioning	Procedure: Standard templating; Total hip replacement with implant positioning guided by standard templating. The experimental and active comparator arms will use the same implants for total hip replacements. The Corin Trinity shell system will be used for the acetabular system. The Corin MiniHip, TriFit, MetaFix and TaperFit implants will be used for the femoral stem implant. Surgeons will select the implant most appropriate for each patient.; Other Names: Anteroposterior and lateral hip radiographs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dislocation rate	Incidence of hip dislocation within 12 months post-operatively	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Harris Hip Score	A clinician recorded outcome score to assess functional improvement.	Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Change in Oxford Hip Score	A patient reported outcome measure (PROM) to assess patient benefit	Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Change in Hip and Groin Outcome Score	A PROM to assess patient benefit	Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Change in International Hip Outcome Tool 33 (iHOT33) Score	A PROM to assess patient benefit	Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Change in EuroQol 5 dimension (EQ5D) Score	A PROM to assess patient benefit	Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Change in University of California, Los Angeles (UCLA) Activity Score	A PROM to assess patient benefit	Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Change in Forgotten Joint Score	A PROM to assess patient benefit	Measured pre-operatively (baseline) and at 3, 6 and 12 months post-operatively
Length of hospital stay	Measurement of the length of the hospital admission for the total hip replacement. Measured in days.	Through study completion, an average of 1 year
Operation duration	Measurement of the length of time of the total hip replacement operation. Measured in minutes.	Through study completion, an average of 1 year
Discrepancy in leg length	Assessment for correction in discrepancy in true leg length from pre-operative to post-operative. Measured in cm	Measured pre-operatively and at 12 months post-operatively

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Oxford University Hospitals NHS Trust; Corin
• Investigators: Principal Investigator: Sion Glyn-Jones, DPhil FRCS, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: arthroplasty; dislocation; templating
• Additional Relevant MeSH Terms: Joint Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Musculoskeletal Diseases
• Other Study ID Numbers: IRAS 216084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the trial steering committee. Requestors will be required to sign a data access agreement
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No