ArthritisBHRNCT00611585
A Safety and Efficacy Study of the Birmingham Hip Resurfacing System
An observational study of Arthritis, run by Smith & Nephew, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Birmingham Hip Resurfacing
- Type of treatment
- Medical device
- How many people
- 329 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Oct 2006to 12 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to: * Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or * Inflammatory arthritis such as rheumatoid arthritis. BHR System is intended for patients who, due to relatively younger age or increase activity level, may not be suitable for traditional total hip arthroplasty due to an increase possibility of requiring future ipsilateral hip joint revision.
Who may be able to join
- Males or females, at least 21 years of age, inclusive, and skeletally mature.
- The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to:
- non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
- inflammatory arthritis such as rheumatoid arthritis.
- The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.
- The subject or his/her legal guardian was willing to consent to participate in the study by signing and dating the approved consent form;
- The subject was available for clinical follow-up through at least ten years postoperative;
- The patient met none of the exclusion criteria.
Who cannot join
- 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 due to unknown effect on the fetus of medal ion release.
- Subjects with bone stock inadequate to support the device including:
- Subjects with severe osteopenia should not receive a BHR procedure. Patients with a family history of severe osteoporosis or sever osteopenia.
- Subjects with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade) should not receive a BHR.
Show all 11Show fewer
- Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
- Subjects with known moderate to severe renal insufficiency. Subjects on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in system medal ion concentration. Preoperative and postoperative monitoring of renal function 9such creatinine, GFR, BUN) at 6wk/3month, 6 month (optional visit), 1-, 2-, 3-, 4,-, 5-, and 10-year time points was necessary.
- Patients who were immunosuppressed with disease such as AIDS or persons receiving high dose of corticosteroids.
- Patients with psychological or neurological conditions which would pre-empt their ability or unwillingness to participate in the study.
- Patients who were severely overweight.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Anderson Orthopaedic Clinic
Alexandria, Virginia, 22306
OrthoCarolina
Charlotte, North Carolina, 28207
Aurora Medical Center
Grafton, Wisconsin, 53024
Center for Orthopaedics
Lake Charles, Louisiana, 70601
Hospital for Special Surgery
New York, New York, 10021
University of Rochester Medical Center
Rochester, New York, 14672
Tucson Orthopaedic Institute
Tucson, Arizona, 85713
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthritis
- Being tested
- Birmingham Hip Resurfacing
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birmingham Hip ResurfacingDevice
Also called BHR
Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Hip Resurfacing | Birmingham Hip Resurfacing Receives: Device: Birmingham Hip Resurfacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Revision by 10 Years
Proportion of participants with revision by 10 years. A revision was defined as removal with or without replacement of the components (device revision may have been partial or total).
Measured: 10 years
Secondary outcomes (16)
Harris Hip Score (HHS): Overall Score
The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and hip Range of Motion (2 items, 0-5 points). Total scores range from 0 to 100 with a higher overall score reflecting improved clinical outcomes (i.e., a higher score was a better outcome).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Pain Score
The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and Range of Motion (2 items, 0-5 points).
The Pain domain assesses the severity of hip pain and its interference with daily activities. The score ranges from 0 to 44, with higher scores representing less pain (i.e., a higher score was a better outcome).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Function Score
The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and Range of Motion (2 items, 0-5 points).
The Function domain evaluates the patient's ability to perform daily activities and gait-related tasks. The Function score ranges from 0 to 47, with higher scores indicating better functional performance and mobility (i.e., a higher score was a better outcome).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Absence of Deformity Score
The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and Range of Motion (2 items, 0-5 points).
The Absence of Deformity domain assesses structural hip alignment and deformity. The Absence of Deformity score ranges from 0 to 4, with higher scores indicating fewer hip deformities (i.e., a higher score was a better outcome).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Range of Motion Score
The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and Range of Motion (2 items, 0-5 points).
The Range of Motion domain assesses structural hip alignment and deformity. The Range of Motion score ranges from 0 to 5, with higher scores indicating greater hip mobility and improved joint function (i.e., a higher score was a better outcome).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Any Radiographic Findings
Independent radiographic assessment to determine radiographic findings (Yes/No). A 'Yes' response for radiographic findings were due to either radiolucencies, migration, osteolysis, stress shielding, or heterotopic ossification.
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Radiolucent Lines
Independent radiographic assessment to determine radiographic findings for presence of any acetabular radiolucent lines (Yes/No).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Migration
Independent radiographic assessment to determine radiographic findings for any acetabular migration (Yes/No).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Osteolysis Lines
Independent radiographic assessment to determine radiographic findings for presence of any acetabular osteolysis lines (Yes/No).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Stress Shielding
Independent radiographic assessment to determine radiographic findings for any acetabular stress shielding (Yes/No).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Radiolucent Lines
Independent radiographic assessment to determine radiographic findings for presence of any femoral radiolucent lines (Yes/No).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Migration
Independent radiographic assessment to determine radiographic findings for any femoral migration (Yes/No).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Osteolysis Lines
Independent radiographic assessment to determine radiographic findings for presence of any femoral osteolysis lines (Yes/No).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Stress Shielding
Independent radiographic assessment to determine radiographic findings for any femoral stress shielding (Yes/No).
Measured: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Heterotopic Ossification
Independent radiographic assessment to determine heterotopic ossification was measured using the Brooker Scale grading. Participants with Heterotopic Ossification were classified by one of the following grade categories:
- I (Islands of bone)
- II (Bone spurs having at least 1 centimeter)
- III (Bone spurs reducing the space to less than 1 centimeter)
- IV (Apparent bony ankylosis of the hip)
- None
Measured: 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Cumulative Number of Revisions
Cumulative number of participants with hip revisions. A revision was defined as removal with or without replacement of the components (device revision may have been partial or total).
Measured: 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study start6 Oct 2006
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andy Engh, MD, Principal investigator, Anderson Orthopaedic ClinicLawrence Housman, MD, Principal investigator, Tucson Orthopaedic InstituteJohn Masonis, MD, Principal investigator, OrthoCarolina Research Institute, Inc.Edwin Su, MD, Principal investigator, Hospital for Special Surgery, New YorkJohn Noble, Jr., MD, Principal investigator, Center for OrthopaedicsMichael Anderson, MD, Principal investigator, Aurora Medical CenterChristopher Drinkwater, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611585
- Sponsor's protocol ID
- BHR.PAS.2006.01
- Acronym
- BHR
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2008
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birmingham Hip Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System
- ClinicalTrials.gov ID
- NCT00611585
- Acronym / sponsor ID
- BHR / BHR.PAS.2006.01
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2006 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip Resurfacing | – | Device: Birmingham Hip ResurfacingBirmingham Hip Resurfacing |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to: * Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or * Inflammatory arthritis such as rheumatoid arthritis. BHR System is intended for patients who, due to relatively younger age or increase activity level, may not be suitable for traditional total hip arthroplasty due to an increase possibility of requiring future ipsilateral hip joint revision.
Key inclusion criteria (8 listed)
- Males or females, at least 21 years of age, inclusive, and skeletally mature.
- The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to:
- non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
- inflammatory arthritis such as rheumatoid arthritis.
- The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.
Key exclusion criteria (11 listed)
- 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 due to unknown effect on the fetus of medal ion release.
- Subjects with bone stock inadequate to support the device including:
- Subjects with severe osteopenia should not receive a BHR procedure. Patients with a family history of severe osteoporosis or sever osteopenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Birmingham Hip ResurfacingAlso: BHRHip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty | Device | Hip Resurfacing |
Primary outcome
Proportion of Participants with Revision by 10 Years
Time frame: 10 years
Proportion of participants with revision by 10 years. A revision was defined as removal with or without replacement of the components (device revision may have been partial or total).
16 secondary outcomes
Harris Hip Score (HHS): Overall Score
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Pain Score
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Function Score
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Absence of Deformity Score
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Range of Motion Score
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Any Radiographic Findings
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Radiolucent Lines
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Migration
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Osteolysis Lines
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Stress Shielding
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Radiolucent Lines
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Migration
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Osteolysis Lines
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Stress Shielding
Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Heterotopic Ossification
Time frame: 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Cumulative Number of Revisions
Time frame: 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Related trials for Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Engh, MD principal investigator
Anderson Orthopaedic Clinic
Lawrence Housman, MD principal investigator
Tucson Orthopaedic Institute
John Masonis, MD principal investigator
OrthoCarolina Research Institute, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Smith & Nephew, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Revision by 10 Years (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.