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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Smith & Nephew, Inc.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT00611585
First received: January 28, 2008
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Arthritis
Device: Birmingham Hip Resurfacing

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Birmingham Hip Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System

Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: post op through 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: September 2006
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hip Resurfacing
Birmingham Hip Resurfacing
Device: Birmingham Hip Resurfacing
Other Names:
  • Birmingham Hip Resurfacing
  • BHR

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611585

Contacts
Contact: Colleen Smith 978.749.1371 colleen.smith@smith-nephew.com
Contact: Cathy Newbill 901-399-6422 cathy.newbill@smithnephew.com

Locations
United States, Arizona
Tucson Orthopaedic Institute Active, not recruiting
Tucson, Arizona, United States, 85713
United States, Florida
Orthopaedic Center of Vero Beach Active, not recruiting
Vero Beach, Florida, United States, 32960
United States, Louisiana
Center for Orthopaedics Active, not recruiting
Lake Charles, Louisiana, United States, 70601
United States, New York
Hospital for Special Surgery Active, not recruiting
New York, New York, United States, 10021
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14672
Contact: Amy Battisti    585-341-0556    amy.battisti@urmc.rochester.edu   
Contact: Allison McIntyre, MPH    585.341.9304    AllisonW_Mcintyre@urmc.rochester.edu   
Principal Investigator: Christopher Drinkwater, MD         
United States, North Carolina
OrthoCarolina Active, not recruiting
Charlotte, North Carolina, United States, 28207
United States, Virginia
Anderson Orthopaedic Clinic Active, not recruiting
Alexandria, Virginia, United States, 22306
United States, Wisconsin
Aurora Medical Center Recruiting
Grafton, Wisconsin, United States, 53024
Contact: Sue Truchan, MD    262-329-8086    sue.truchan@aurora.org   
Contact: , RN         
Principal Investigator: Michale Anderson, MD         
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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
Principal Investigator: Michael Anderson, MD Aurora Medical Center
Principal Investigator: Christopher Drinkwater, MD University of Rochester
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT00611585     History of Changes
Other Study ID Numbers: BHR
Study First Received: January 28, 2008
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 01, 2014