Clinical trial NCT00611585: A Safety and Efficacy Study of the Birmingham Hip Resurfacing System
Official title: Birmingham Hip Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 360
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score
timeFrame: 3 months, 1-10 years
Secondary outcomes:
measure: Adverse events
timeFrame: post op through 10 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Lake Charles
country: United States
facility: Center for Orthopaedics
state: Louisiana
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Alexandria
country: United States
facility: Anderson Orthopaedic Clinic
state: Virginia
city: Grafton
country: United States
facility: Aurora Medical Center
state: Wisconsin
Study officials:
affiliation: Anderson Orthopaedic Clinic
name: Andy Engh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tucson Orthopaedic Institute
name: Lawrence Housman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OrthoCarolina Research Institute, Inc.
name: John Masonis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Edwin Su, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Orthopaedics
name: John Noble, Jr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aurora Medical Center
name: Michael Anderson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Christopher Drinkwater, MD
role: PRINCIPAL_INVESTIGATOR
References: