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

NCT00872547 | Terminated Phase 4

• 1 other identifier: CT05/18
• Study Type: interventional
• Target: 329
• Locations: 8 countries
• Sites: 8

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.

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)

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier survivorship calculated at the five-year time-point

  5yrs

Secondary Outcomes (7)

• Annual Kaplan-Meier survivorship calculations

  Annually

• Harris Hip Score

  3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery

• Radiographic analysis

  3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery

• Oxford Hip Score

  3mths, 6mths and annually post-surgery

• UCLA Activity Score

  3mths, 6mths and annually post-surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Resurfacing system

Device: DePuy ASR™ Hip System

2

ACTIVE COMPARATOR

Large Metal-on-Metal Total Hip Replacement

Device: DePuy ASR™ XL Head / ASR™ Acetabular Cup System

Interventions

DePuy ASR™ Hip System DEVICE

Resurfacing system

1

DePuy ASR™ XL Head / ASR™ Acetabular Cup System DEVICE

Large Metal-on-Metal Total Hip Replacement

2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (8)

University Clinic for Orthopaedics and Orthopaedic Surgery - LKH

Graz, Austria

Location

Znojmo Hospital

Znojmo, Czechia

Location

Coxa, Hospital for Joint Replacement

Tampere, Finland

Location

Klinikum der Universität zu

Cologne, Germany

Location

Elverum Hospital

Elverum, Norway

Location

Hospital Curry Cabral

Lisbon, Curry Cabral, Portugal

Location

Kant. Spital Sursee-Wolhusen

Wolhusen, Switzerland

Location

Royal Berkshire Hospital, UK

Reading, Berkshire, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Collagen Diseases; Osteonecrosis; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: September 1, 2006
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 4, 2016

Record last verified: 2016-07

Locations

CZ (1); DE (1); FI (1); PT (1); AU (1); CH (1); GB (1); NO (1)