A prospective, single arm, open label study assessing the performance and safety of the Birmingham Hip Resurfacing system in relatively young males with primary arthritis of the hip requiring hip replacement. - BHR studie

Kliniek Orthopedium0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•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)

•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

发起方

Kliniek Orthopedium