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

NCT02696395 | Unknown

• 1 other identifier: DePuy RSA RCT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-Lock® femoral stem vs DePuy Corail® femoral stem (mm/yr).

  3 years

Secondary Outcomes (4)

• 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

Study Arms (2)

DePuy Tri-Lock®

ACTIVE COMPARATOR

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

DePuy Corail®

ACTIVE COMPARATOR

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

Interventions

DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component DEVICE

DePuy Tri-Lock®

DePuy Corail® femoral stem + Deltamotion® acetabular component DEVICE

DePuy Corail®

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• DePuy International: collaborator

Study Sites (1)

Nuffield Orthopaedic Centre

Oxford, OX3 7HE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: March 2, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 2, 2016

Record last verified: 2016-02

Locations

GB (1)