Arthritis of the hip coxarthrosis osteoarthitis
Conditions
Interventions
The selected patient group in this study is already qualfied for a hip
replacement. The intervention in this trail is the implantation of the BHR
resrurfacing implant instead of the standard total h
Sponsors
Kliniek Orthopedium
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Male patients between 18 and 60 years of age 2.Patients requiring hip replacement, suitable for the use of the BHR system 3.Patients with an endstage of primary arthritis of the hip 4.Patients with a femoral head * 50 mm (as measured by calibrated X-ray imaging)
Exclusion criteria
Exclusion criteria: 1.Patients with a BMI >35 2.Patients with infection or sepsis 3.Patients with bone stock inadequate to support the device including: a.Patients with severe osteopenia or with a family history of severe osteoporosis or severe osteopenia b.Patients with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT grade) c.Patients with multiple cysts of the femoral head (> 1cm) 4.Patients with known moderate to severe renal insufficiency 5.Patients who are immunologically suppressed with diseases such as AIDS, or patients who are receiving corticosteroids in high doses 6.Patients with known or suspected metal sensitivity 7.Patients who are skeletally immature 8.Patients with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery 9. Patients suffering from diabetes type I or II
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure for efficacy in this study is the Oxfrd Hip Score. This is a common outcome measure for this type of studies as shown in literature. The safety outcome is defined as the incidence of device related adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Evaluation of overall survival of the BHR * Evaluation of quality of life, as assessed by the EQ-5D score, the Harris Hip Score (HHS) and the Hip disability and Osteoarthritis Outcome Score (HOOS) over time * Evaluation of cobalt blood concentrations over time * Evaluation of the acetabular component positioning by X-ray | — |
Countries
Netherlands
Outcome results
None listed