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

Not Applicable

• Conditions: Hip Osteoarthritis
• Interventions: Device: DePuy Corail® femoral stem + Deltamotion® acetabular component; Device: DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component

• Registration Number: NCT02696395
• Lead Sponsor: University of Oxford

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-11-16
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-25
• Last Update Submitted: 2016-02-25
• Study First Posted: 2016-03-02
• Last Update Posted: 2016-03-02
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DePuy Corail®	DePuy Corail® femoral stem + Deltamotion® acetabular component	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.
DePuy Tri-Lock®	DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Nuffield Orthopaedic Centre; 🇬🇧 Oxford, United Kingdom