Massachusetts General Hospital Evaluation of DePuy ASR Hip System

• Conditions: Osteoarthritis

• Registration Number: NCT01611233
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a higher than expected revision rate reported in the England/Wales and Australian national joint registries. There are two types of ASR hip implants used for total hip replacement surgery:

* ASR XL Hip System

* ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the study sponsor. MGH is conducting this study with the help of funding from DePuy Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects around the world. The countries include the United States of America, Australia, South Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH will analyze the data annually for 6 years.

The purpose of this study is to follow patients who have the ASR hip system for the next 6 years. The findings of this study may help surgeons to make better informed decisions about monitoring and treatment of patients with ASR hip systems.

Detailed Description

Description of the Subject Population:

* Adults who have previously undergone a surgery implanting the DePuy ASR XL Acetabular Hip System or ASR Hip Resurfacing System;

* ASR patients who are already being followed-up by their surgeon at least once a year. This routine follow-up care consists of a clinic visit, blood tests, X-rays and possibly an MRI, Ultrasound or CT scan.

Study Timeline

• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Study Start: 2012-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-07
• Primary Completion: 2022-04
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1950

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants	From the date of primary hip replacement surgery to the end of the study (up to 6 (+/- 0.5) years after enrollment) or to the date of revision surgery, whichever event occurs first.	To quantify implant failure rates following voluntary recall of the ASR implant

Secondary Outcome Measures

Name	Time	Method
Plain radiographic, ultrasound and/or MRI evaluation	Within 24 months before enrollment, each annual follow-up visit and within 6 months before revision surgery (last images results <= 6.5 years after enrollment date)	To measure component positioning and implant stability in patients with the ASR metal-on-metal implant
Patient reported outcome scores: UCLA, Harris Hip, Case Mix Indicator and EQ-5D	At enrollment and each of the 5 annual follow-up visits ((last surveys <= 6.5 years after enrollment date, unless there is revision surgery, then at the last annual follow-up visit)	To quantify patient reported variables such as pain, activity, and function using validated questionnaires
Incidence of adverse local tissue reaction	On the date of revision surgery, not later than the last, 5 year study follow-up visit (<= 6.5 years after enrollment)	To quantify incidence of adverse local tissue reaction due to metal debris released from the metal-on-metal ASR implant
Cobalt and Chromium ion levels in serum	Within 24 months before enrollment, at each annual follow-up visit; within 6 months before and then within 6 months after revision surgery (last test results <= 7 years after enrollment date)	To quantify the levels of cobalt and chromium ions in blood serum for patients with the ASR metal-on-metal implant

Trial Locations

Locations (13)

Texas Hip and Knee Center; 🇺🇸 Fort Worth, Texas, United States

Sportsmed Sa; 🇦🇺 Stepney, South Australia, Australia

Morningside Medi-Clinic; 🇿🇦 Bryanston, South Africa

Royal Berkshire Hospital; 🇬🇧 Reading, Berkshire, United Kingdom

Sheffield Teaching Hospitals Foundation Trust; 🇬🇧 Sheffield, United Kingdom

Rotherham NHS Foundation Trust, Rotherham Hospital; 🇬🇧 Rotherham, United Kingdom

Istituti Ospedalieri Bresciani S.p.A.; 🇮🇹 Brescia, Italy

Cape Hip and Knee Practice; 🇿🇦 Cape Town, South Africa

Northshore University HealthSystem, Glenbrook Hospital; 🇺🇸 Glenview, Illinois, United States

Summit Orthopedics; 🇺🇸 Woodbury, Minnesota, United States

Syracuse Orthopedic Specialists; 🇺🇸 Syracuse, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Westville Hospital; 🇿🇦 Durban, South Africa