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

Hip Osteoarthritis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02696395
• Other study ID #: DePuy RSA RCT
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2015
• Last updated: February 25, 2016
• Start date: July 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2016
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: NHS Health research AuthorityUnited Kingdom: Oxford University Hospitals NHS Foundation TrustUnited Kingdom: University of Oxford
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component

• DePuy Corail® femoral stem + Deltamotion® acetabular component

Locations

Country	Name	City	State
United Kingdom	Nuffield Orthopaedic Centre	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	DePuy International

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean total Radio Stereometric Analysis (RSA) measured migration of DePuy Tri-Lock® femoral stem vs DePuy Corail® femoral stem (mm/yr).		3 years	No
Secondary	Dynamically Inducible Micromotion (DIMM) of DePuy Corail®, Tri-Lock® and Deltamotion® components (mm/yr).		3 years	No
Secondary	Radio Stereometric Analysis (RSA) measured migration of DePuy Deltamotion® acetabular component		3 years	No
Secondary	Change in Oxford Hip Score (OHS) at three years.		3 years	No
Secondary	Change in bone density using Dual Energy X-Ray Absorptiometry (DEXA) scan at 12 months.		1 year	No