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

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ClinicalTrials.gov Identifier: NCT02696395
Recruitment Status : Recruiting
First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Sponsor:
Collaborator:
DePuy International
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Device: DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component Device: DePuy Corail® femoral stem + Deltamotion® acetabular component Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-lock, Corail and Deltamotion Hip Replacement Components: a Single-blinded Randomised Control Trial
Study Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

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



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

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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696395


Locations
United Kingdom
Nuffield Orthopaedic Centre Recruiting
Oxford, United Kingdom, OX3 7HE
Contact: Sion Glyn-Jones, MA, DPhil, FRCS    +441865737839    sion.glyn-jones@ndorms.ox.ac.uk   
Contact: John Broomfield, MBChB, MSc, MRCS    +441865223422    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         
Sponsors and Collaborators
University of Oxford
DePuy International

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02696395     History of Changes
Other Study ID Numbers: DePuy RSA RCT
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases