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

Primary Purpose

Arthritis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Birmingham Hip Resurfacing
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tucson Orthopaedic Institute
  • Center for Orthopaedics
  • Hospital for Special Surgery
  • University of Rochester Medical Center
  • OrthoCarolina
  • Anderson Orthopaedic Clinic
  • Aurora Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hip Resurfacing

Arm Description

Birmingham Hip Resurfacing

Outcomes

Primary Outcome Measures

Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score

Secondary Outcome Measures

Adverse events

Full Information

First Posted
January 28, 2008
Last Updated
November 7, 2022
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00611585
Brief Title
A Safety and Efficacy Study of the Birmingham Hip Resurfacing System
Acronym
BHR
Official Title
Birmingham Hip Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hip Resurfacing
Arm Type
Other
Arm Description
Birmingham Hip Resurfacing
Intervention Type
Device
Intervention Name(s)
Birmingham Hip Resurfacing
Other Intervention Name(s)
BHR
Intervention Description
Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty
Primary Outcome Measure Information:
Title
Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score
Time Frame
3 months, 1-10 years
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
post op through 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Engh, MD
Organizational Affiliation
Anderson Orthopaedic Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Housman, MD
Organizational Affiliation
Tucson Orthopaedic Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Masonis, MD
Organizational Affiliation
OrthoCarolina Research Institute, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edwin Su, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Noble, Jr., MD
Organizational Affiliation
Center for Orthopaedics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Anderson, MD
Organizational Affiliation
Aurora Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Drinkwater, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85713
Country
United States
Facility Name
Center for Orthopaedics
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14672
Country
United States
Facility Name
OrthoCarolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Anderson Orthopaedic Clinic
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22306
Country
United States
Facility Name
Aurora Medical Center
City
Grafton
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

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