Prospective follow-up of clinical efficacy of knee distraction as treatment for knee osteoarthritis by use of ‘ArthroSave’s Knee-Reviver’

MC Utrecht0 个研究点目标入组 75 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria
•-adults =65 years of age (at higher ages cost-benefit is becoming less; 15)
•-BMI < 35 kg/m2 (mechanical safety limit of device) (with max 110 kg body weight)
•-Normal-good physical condition (arbitrary defined by orthopaedic surgeons)
•-Sufficient knee joint stability (arbitrary defined by orthopaedic surgeons)
•-Sufficient range of motion (arbitrary defined by orthopaedic surgeons)
•-Radiographic signs of joint damage (KL grade 2-4)
•-VAS (visual analogue scale) pain >40/100 (conservative treatment resistant)

•General: Patients that would not be considered for arthroplasty or osteotomy because of psychosocial condition; or who meet any of the following criteria will be excluded from participation in this study:
•-Comorbidities that would compromise the efficacy of knee joint distraction (arbitrary defined by orthopaedic surgeons)
•-History of inflammatory or septic arthritis
•-Knee mal-alignment of more than 10 degrees
•-Previous surgical interventions of the index knee < 6 months ago
•-Absence of any joint space width on both sides (medial and lateral) of X-ray
•-presence of an endo-prostheses elsewhere

发起方

MC Utrecht