RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-Lock, Corail and Deltamotion Hip Replacement Components (DePuy RSA RCT)

RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-lock, Corail and Deltamotion Hip Replacement Components: a Single-blinded Randomised Control Trial

Hip replacements are being performed on an increasingly active population, who are likely to wear their implants out prematurely. New hip replacements have been devised to minimise the risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the performance of two established types of hip replacements using Corail and Tri-Lock stems along with Deltamotion acetabular component. The primary objective of the trial is to compare the long term stability of these two devices.To do this, the study will use an advanced 3D Xray technique to detect migration of the components at 3 years. The study will also measure micromotion of Corail, Tri-Lock and Deltamotion components, patient reported outcome measures and change in bone density.This study is being conducted at a single site, at the Nuffield Orthopaedic Centre, Oxford.

Study Overview

• Status: Unknown
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component; Device: DePuy Corail® femoral stem + Deltamotion® acetabular component

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 7HE
    • Recruiting
    • Nuffield Orthopaedic Centre
    • Contact: Sion Glyn-Jones, MA, DPhil, FRCS; Phone Number: +441865737839; Email: sion.glyn-jones@ndorms.ox.ac.uk
    • Contact: John Broomfield, MBChB, MSc, MRCS; Phone Number: +441865223422; Email: john.broomfield@ndorms.ox.ac.uk
    • Principal Investigator: Sion Glyn-Jones, MA, DPhil, FRCS
    • Sub-Investigator: Adrian Taylor
    • Sub-Investigator: David Beard
    • Sub-Investigator: Duncan Whitwell
    • Sub-Investigator: Ramy Mansour
    • Sub-Investigator: Ben Kendrick
    • Sub-Investigator: John Broomfield

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Women aged between 18 and 65 years and men aged between 18 and 70 years.

  • Participant is willing and able to give informed consent for participation in the study.
  • Diagnosed with hip osteoarthritis.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

• Any patients with an inflammatory arthropathy, osteoporosis or deformities of the proximal femur.

  • Patients who have significant co-morbidities that would make follow-up difficult or uncomfortable.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DePuy Tri-Lock®; Total hip replacement with DePuy Tri-Lock® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care.	Device: DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component
Active Comparator: DePuy Corail®; Total hip replacement with DePuy Corail® femoral stem and Deltamotion® acetabular component. The surgery will be conducted using a postero-lateral approach followed by post operative rehabilitation as per standard care.	Device: DePuy Corail® femoral stem + Deltamotion® acetabular component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-Lock® femoral stem vs DePuy Corail® femoral stem (mm/yr).	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Dynamically Inducible Micromotion (DIMM) of DePuy Corail®, Tri-Lock® and Deltamotion® components (mm/yr).	3 years
Radio Stereometric Analysis (RSA) measured migration of DePuy Deltamotion® acetabular component	3 years
Change in Oxford Hip Score (OHS) at three years.	3 years
Change in bone density using Dual Energy X-Ray Absorptiometry (DEXA) scan at 12 months.	1 year

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: DePuy International

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Estimate): March 2, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: DePuy RSA RCT