A Prospective, Multi-Center, Post-Market Clinical Two Year Follow-Up Study that Hydroxyapatite coated stem shows Osseointegration New Evidence using DEXA and Tomosynthesis (HONE study) - A Prospective, Multi-Center, Post-Market Clinical Two Year Follow-Up Study that Hydroxyapatite coated stem shows Osseointegration New Evidence using DEXA and Tomosynthesis (HONE study)

Jilei University Hospital0 个研究点目标入组 152 人开始时间: 2021年1月21日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•1Acute or chronic infection, local or systemic 2Severe muscle, nerve, or vascular diseases that endanger the extremity 3Has previously received THA in the index joint 4Any of the following conditions in the contralateral joint: Has received THA as a revision for a failed procedure Has received THA that is not fully healed and well-functioning in the opinion of the Investigators 5Current diagnosis of immunosuppressive disorder 6History of cancer within 5 years of screening 7Known allergy to any component of the study device 8Conditions known to interfere with THA survival or outcomes including vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal disease, neuromuscular disease 9Current diagnosis of fibromyalgia 10 Mass Index (BMI) over 40 11 Currently enrolled or has participated in a clinical research study (drug, device, or biologic) within 30 days of screening 12Has previously history of femur neck fracture 13Acetabular osteotomy in the index joint

发起方

Jilei University Hospital