Assessing the safety and performance of a hip resurfacing prosthesis compared with a conventional total hip prosthesis in relatively young males with primary arthritis; a prospective, controlled clinical study. - BHR2014 study

Kliniek Orthopedium0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1.Male patients between 18 and 60 years of age
•2.Patients requiring primary hip replacement
•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