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A Safety and Efficacy Study of the Birmingham Hip Resurfacing System (BHR)

This study is currently recruiting participants.
Verified May 2013 by Smith & Nephew, Inc.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT00611585
First received: January 28, 2008
Last updated: May 1, 2013
Last verified: May 2013
History of Changes

January 28, 2008
May 1, 2013
September 2006
December 2026   (final data collection date for primary outcome measure)
Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score [ Time Frame: 3 months, 1-10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00611585 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: post op through 10 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study of the Birmingham Hip Resurfacing System
Birmingham Hip Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System

The purpose of this study is to meet a PMA condition of approval of the BHR System. The study will evaluate the long term safety and effectiveness of the BHR system in patients with non-inflammatory and inflammatory arthritis.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthritis
Device: Birmingham Hip Resurfacing
Other Names:
  • Birmingham Hip Resurfacing
  • BHR
Hip Resurfacing
Birmingham Hip Resurfacing
Intervention: Device: Birmingham Hip Resurfacing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2026
December 2026   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 21 years of age and skeletally mature
  • Patients requiring primary hip resurfacing due to:
  • Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH
  • Inflammatory arthritis such as rheumatoid arthritis
  • Subject or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form
  • Subject is available for clinical follow-up through at least ten years
  • Subject meets none of the exclusion criteria

Exclusion Criteria:

  • Subjects with infection or sepsis
  • Subjects with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery
  • Female subjects of child-bearing age
  • Subjects with bone stock inadequate to support the device
  • Subjects with known moderate to severe renal insufficiency
  • Subjects with known or suspected metal sensitivity (e.g. jewelry)
  • Subjects who are immunosuppressed with diseases such as AIDS or persons receiving high doses of corticosteroids
  • Subjects with psychological or neurological conditions which would pre-empt their ability or unwillingness to participate in the study
  • Subjects who are severely overweight
Both
20 Years to 75 Years
No
Contact: Tunja Carter 901-399-5356 ext 5356 tunja.carter@smithnephew.com
Contact: Cathy Newbill 901-399-6422 cathy.newbill@smithnephew.com
United States
 
NCT00611585
BHR
No
Smith & Nephew, Inc.
Smith & Nephew, Inc.
Not Provided
Principal Investigator: Andy Engh, MD Anderson Orthopaedic Clinic
Principal Investigator: Lawrence Housman, MD Tucson Orthopaedic Institute
Principal Investigator: John Masonis, MD OrthoCarolina Research Institute, Inc.
Principal Investigator: Edwin Su, MD Hospital for Special Surgery, New York
Principal Investigator: John Noble, Jr., MD Center for Orthopaedics
Principal Investigator: Richard Steinfeld, MD Orthopaedic Center of Vero Beach
Smith & Nephew, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP