Arthritis
Conditions
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.
Interventions
Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
A. Males or females, at least 21 years of age, inclusive, and skeletally mature. B. 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. C. The subject or his/her legal guardian was willing to consent to participate in the study by signing and dating the approved consent form; D. The subject was available for clinical follow-up through at least ten years postoperative; E. The patient met none of the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with Revision by 10 Years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS): Overall Score | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | 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). |
| Harris Hip Score (HHS): Pain Score | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | 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). |
| Harris Hip Score (HHS): Function Score | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | 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). |
| Harris Hip Score (HHS): Absence of Deformity Score | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | 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). |
| Harris Hip Score (HHS): Range of Motion Score | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | 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). |
| Radiographic Assessment: Any Radiographic Findings | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | 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. |
| Radiographic Assessment: Radiographic Findings for Acetabular Radiolucent Lines | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | Independent radiographic assessment to determine radiographic findings for presence of any acetabular radiolucent lines (Yes/No). |
| Radiographic Assessment: Radiographic Findings for Acetabular Migration | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | Independent radiographic assessment to determine radiographic findings for any acetabular migration (Yes/No). |
| Radiographic Assessment: Radiographic Findings for Acetabular Osteolysis Lines | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | Independent radiographic assessment to determine radiographic findings for presence of any acetabular osteolysis lines (Yes/No). |
| Radiographic Assessment: Radiographic Findings for Acetabular Stress Shielding | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | Independent radiographic assessment to determine radiographic findings for any acetabular stress shielding (Yes/No). |
| Radiographic Assessment: Radiographic Findings for Femoral Radiolucent Lines | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | Independent radiographic assessment to determine radiographic findings for presence of any femoral radiolucent lines (Yes/No). |
| Radiographic Assessment: Radiographic Findings for Femoral Migration | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | Independent radiographic assessment to determine radiographic findings for any femoral migration (Yes/No). |
| Radiographic Assessment: Radiographic Findings for Femoral Osteolysis Lines | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | Independent radiographic assessment to determine radiographic findings for presence of any femoral osteolysis lines (Yes/No). |
| Radiographic Assessment: Radiographic Findings for Femoral Stress Shielding | Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | Independent radiographic assessment to determine radiographic findings for any femoral stress shielding (Yes/No). |
| Radiographic Assessment: Heterotopic Ossification | 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years | 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 |
| Cumulative Number of Revisions | 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndy Engh, MD
Anderson Orthopaedic Clinic
PRINCIPAL_INVESTIGATORLawrence Housman, MD
Tucson Orthopaedic Institute
PRINCIPAL_INVESTIGATORJohn Masonis, MD
OrthoCarolina Research Institute, Inc.
PRINCIPAL_INVESTIGATOREdwin Su, MD
Hospital for Special Surgery, New York
PRINCIPAL_INVESTIGATORJohn Noble, Jr., MD
Center for Orthopaedics
PRINCIPAL_INVESTIGATORMichael Anderson, MD
Aurora Medical Center
PRINCIPAL_INVESTIGATORChristopher Drinkwater, MD
University of Rochester
Outcome results
None listed