Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement

Rheumatoid Arthritis Clinical Trial

Official title:

Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of a Large Metal-on-Metal (MoM) Bearing Comprising a DePuy ASR™ Cup in Conjunction With Either a DePuy ASR™ Hip Resurfacing Femoral Component or a DePuy ASR™ XL Head in Subjects With Indications Suitable for Either a Primary Resurfacing Arthroplasty or Primary Total Hip Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00872547
• Other study ID #: CT05/18
• Status: Terminated
• Phase: Phase 4
• First received: March 30, 2009
• Last updated: August 3, 2016
• Start date: September 2006
• Est. completion date: November 2011

Study information

• Verified date: July 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to monitor the performance of a large metal-on-metal bearing from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery or a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

The Study was terminated with effect from 30th November 2011 following the completion of 2 year follow up assessments for those patients remaining in the study.

Please note that prior to this decision DePuy voluntarily recalled the ASR products on 24 August 2010. Additional information regarding this voluntary recall and the follow-up of patients affected by the recall can be found at the following links http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON155761 and http://www.depuy.com/countries_list.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 329
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

General Inclusion Criteria:

i) Male or female subjects, aged between 18 and 65 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects, who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

Inclusion Criteria for DePuy ASR™ Resurfacing system:

i) Subjects with primary osteoarthritis indicated for standard MoM hip resurfacing arthroplasty with cementless fixation in the acetabulum.

Inclusion Criteria for ASR™ XL Head system:

i) Subjects whose bone morphology and bone quality mean that standard MoM hip resurfacing arthroplasty is not indicated, but for whom cementless fixation in the acetabulum and receipt of a large MoM bearing are still possible.

General Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects with compromised renal function defined as those whose measured values lie outside the normal range for a particular investigational site.

iii) Subjects with proven metal sensitivity.

iv) Subjects with infectious, highly communicable diseases, which may limit follow-up i.e. Active tuberculosis, hepatitis, immuno-compromised conditions, etc.

v) Women who are pregnant or who intend to become pregnant within 2 years of surgery.

vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

vii) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

viii) Subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.

ix) Subjects who are currently involved in any injury litigation claims.

x) Subjects who are undergoing corticosteroid treatment.

xi) Subjects with active or recent joint sepsis.

Additional Exclusion Criteria for DePuy ASR™:

i) Subjects with proven significant osteoporosis and poor bone quality.

ii) Subjects with marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable.

iii) Subjects whose anatomical CCD angle is below 120°.

iv) Subjects who have undergone irradiation of the affected hip.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Collagen Diseases
• Collagen Disorders
• Congenital Hip Dysplasia
• Femoral Fractures
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Nonunion of Femoral Fractures
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Slipped Capital Femoral Epiphyses
• Slipped Capital Femoral Epiphysis

Intervention

Device:
• DePuy ASR™ Hip System
Resurfacing system
• DePuy ASR™ XL Head / ASR™ Acetabular Cup System
Large Metal-on-Metal Total Hip Replacement

Locations

Country	Name	City	State
Austria	University Clinic for Orthopaedics and Orthopaedic Surgery - LKH	Graz
Czech Republic	Znojmo Hospital	Znojmo
Finland	Coxa, Hospital for Joint Replacement	Tampere
Germany	Klinikum der Universität zu	Köln
Norway	Elverum Hospital	Elverum
Portugal	Hospital Curry Cabral	Lisboa	Curry Cabral
Switzerland	Kant. Spital Sursee-Wolhusen	Wolhusen
United Kingdom	Royal Berkshire Hospital, UK	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

Austria,  Czech Republic,  Finland,  Germany,  Norway,  Portugal,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier survivorship calculated at the five-year time-point		5yrs	Yes
Secondary	Annual Kaplan-Meier survivorship calculations		Annually	Yes
Secondary	Harris Hip Score		3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery	No
Secondary	Radiographic analysis		3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery	No
Secondary	Oxford Hip Score		3mths, 6mths and annually post-surgery	No
Secondary	UCLA Activity Score		3mths, 6mths and annually post-surgery	No
Secondary	Hip Outcome Score		3mths, 6mths and annually post-surgery	No
Secondary	EuroQol EQ-5D		3mths, 6mths and annually post-surgery	No