A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

Smith & Nephew, Inc.329 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

329

Conditions

Arthritis

Interventions

Birmingham Hip ResurfacingDEVICE

Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: A. Subjects with infection or sepsis, B. Subjects with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery, C. Female subjects of child-bearing age due to unknown effect on the fetus of medal ion release. D. 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. * Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock. E. 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. F. Patients who were immunosuppressed with disease such as AIDS or persons receiving high dose of corticosteroids. G. Patients with psychological or neurological conditions which would pre-empt their ability or unwillingness to participate in the study. H. Patients who were severely overweight.

Locations (7)

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Center for Orthopaedics

Lake Charles, Louisiana, United States

Hospital for Special Surgery

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

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).

Time frame: 10 years

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

Data from ClinicalTrials.gov

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