Clinical trial NCT00872547: Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Osteoarthritis
Post-traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Keywords: Hip
Resurfacing
Metal-on-Metal
Large Heads
XL Head
ASR - osteoarthritis (primary)
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2009-03-31
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Kaplan-Meier survivorship calculated at the five-year time-point
timeFrame: 5yrs
Secondary outcomes:
measure: Annual Kaplan-Meier survivorship calculations
timeFrame: Annually
measure: Harris Hip Score
timeFrame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
measure: Radiographic analysis
timeFrame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
measure: Oxford Hip Score
timeFrame: 3mths, 6mths and annually post-surgery
measure: UCLA Activity Score
timeFrame: 3mths, 6mths and annually post-surgery
measure: Hip Outcome Score
timeFrame: 3mths, 6mths and annually post-surgery
measure: EuroQol EQ-5D
timeFrame: 3mths, 6mths and annually post-surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University Clinic for Orthopaedics and Orthopaedic Surgery - LKH
city: Znojmo
country: Czech Republic
facility: Znojmo Hospital
city: Tampere
country: Finland
facility: Coxa, Hospital for Joint Replacement
city: Köln
country: Germany
facility: Klinikum der Universität zu
city: Elverum
country: Norway
facility: Elverum Hospital
city: Lisboa
country: Portugal
facility: Hospital Curry Cabral
state: Curry Cabral
city: Wolhusen
country: Switzerland
facility: Kant. Spital Sursee-Wolhusen
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital, UK
state: Berkshire
Study officials:
References: