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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00611585
Recruitment Status : Active, not recruiting
First Posted : February 11, 2008
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Arthritis Device: Birmingham Hip Resurfacing

Detailed Description:
This is a post-approval, prospective, non-randomized, longitudinal, unmasked, multi-center, clinical trial designed to evaluate the longer-term safety and effectiveness of the BHR system. The data collected will permit clinical evaluation for the device performance in improving hip pain, function and range of motion through ten years. The study will permit radiographic evaluation of proper component fixation and alignment maintenance through 10 years post-operative. The incidence of revision is an especially important measure in this study. Data collected will allow analysis of the implant survivorship.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 359 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2006
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026
Arms and Interventions

Arm Intervention/treatment
Hip Resurfacing
Birmingham Hip Resurfacing
Device: Birmingham Hip Resurfacing
Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty
Other Name: BHR


Outcome Measures

Primary Outcome Measures :
  1. Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score [ Time Frame: 3 months, 1-10 years ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: post op through 10 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611585


Locations
United States, Arizona
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85713
United States, Florida
Orthopaedic Center of Vero Beach
Vero Beach, Florida, United States, 32960
United States, Louisiana
Center for Orthopaedics
Lake Charles, Louisiana, United States, 70601
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
University of Rochester Medical Center
Rochester, New York, United States, 14672
United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28207
United States, Virginia
Anderson Orthopaedic Clinic
Alexandria, Virginia, United States, 22306
United States, Wisconsin
Aurora Medical Center
Grafton, Wisconsin, United States, 53024
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: Michael Anderson, MD Aurora Medical Center
Principal Investigator: Christopher Drinkwater, MD University of Rochester
More Information

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT00611585     History of Changes
Other Study ID Numbers: BHR
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017