Massachusetts General Hospital Evaluation of DePuy ASR Hip System

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01611233

Collaborator

Depuy, Inc. (Industry)

1,950

Enrollment

Locations

123

Anticipated Duration (Months)

150

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis

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 Design

Study Type:

Observational

Actual Enrollment :

1950 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Follow-up of ASR Patients Post-Recall

Actual Study Start Date :

Sep 1, 2012

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
DePuy ASR THA Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall.

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Any patient with on-label use of the ASR-XL or ASR component system currently implanted.
Able to provide informed consent previously approved by institution's Institutional Review board (IRB) or ethics committee (EC).
Able to return for follow-up.
Able to complete the required patient reported outcome measures.

Exclusion Criteria

Any patient with off-label use indications for the ASR-XL or ASR component system.
Any patient who received the ASR-XL implant as a result of a hip resurfacing conversion or a revision THA.
Subjects with difficulty in comprehending the Informed Consent Form for any reason.
The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, or the medical office staff.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northshore University HealthSystem, Glenbrook Hospital	Glenview	Illinois	United States	60201
2	Summit Orthopedics	Woodbury	Minnesota	United States	55125
3	Syracuse Orthopedic Specialists	Syracuse	New York	United States	13214
4	Duke University Medical Center	Durham	North Carolina	United States	27710
5	Texas Hip and Knee Center	Fort Worth	Texas	United States	76104
6	Sportsmed Sa	Stepney	South Australia	Australia	5069
7	Istituti Ospedalieri Bresciani S.p.A.	Brescia		Italy	25127
8	Morningside Medi-Clinic	Bryanston		South Africa	2021
9	Cape Hip and Knee Practice	Cape Town		South Africa	7708
10	Westville Hospital	Durban		South Africa	3629
11	Royal Berkshire Hospital	Reading	Berkshire	United Kingdom	RG1 5AN
12	Rotherham NHS Foundation Trust, Rotherham Hospital	Rotherham		United Kingdom	S60 2UD
13	Sheffield Teaching Hospitals Foundation Trust	Sheffield		United Kingdom	S10 2SE