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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)

Primary Purpose

Hip Osteoarthritis

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

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

DePuy Corail® femoral stem + Deltamotion® acetabular component

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nuffield Orthopaedic CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

DePuy Tri-Lock®

DePuy Corail®

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dynamically Inducible Micromotion (DIMM) of DePuy Corail®, Tri-Lock® and Deltamotion® components (mm/yr).

Radio Stereometric Analysis (RSA) measured migration of DePuy Deltamotion® acetabular component

Change in Oxford Hip Score (OHS) at three years.

Change in bone density using Dual Energy X-Ray Absorptiometry (DEXA) scan at 12 months.

Full Information

NCT ID

NCT02696395

First Posted

November 16, 2015

Last Updated

February 25, 2016

Sponsor

University of Oxford

Collaborators

DePuy International

1. Study Identification

Unique Protocol Identification Number

NCT02696395

Brief Title

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

Acronym

DePuy RSA RCT

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 Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

Collaborators

DePuy International

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DePuy Tri-Lock®

Arm Type

Active Comparator

Arm Description

Arm Title

DePuy Corail®

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

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

Intervention Type

Device

Intervention Name(s)

DePuy Corail® femoral stem + Deltamotion® acetabular component

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Dynamically Inducible Micromotion (DIMM) of DePuy Corail®, Tri-Lock® and Deltamotion® components (mm/yr).

Time Frame

3 years

Title

Radio Stereometric Analysis (RSA) measured migration of DePuy Deltamotion® acetabular component

Time Frame

3 years

Title

Change in Oxford Hip Score (OHS) at three years.

Time Frame

3 years

Title

Change in bone density using Dual Energy X-Ray Absorptiometry (DEXA) scan at 12 months.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Nuffield Orthopaedic Centre

City

Oxford

ZIP/Postal Code

OX3 7HE

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact: