12 month study to evaluate the safety and performance of the iBalance Axial Knee Realignment System in patients with symptomatic knee pain, displaying medial compartment osteoarthritis with varus malalignment

iBalance Medical Inc.0 个研究点目标入组 25 人开始时间: 2007年8月21日最近更新: 2020年1月13日

试验速览

暂无简介。

•Require 3-12 degrees of varus correction
•Localized pain in posterior-medial quadrant of knee
•Grades II, III, and IV medial compartment knee osteoarthritis (Kellgren-Lawrence Scale)

•1) Diabetes (any type or status) or any metabolic disorder or other condition which may impair bone formation (e.g. osteoporosis)
•2) Inflammatory joint disease
•3) Patients who, in the opinion of the investigator, have a medical condition that would preclude this patient from completing the study (e.g. concurrent chronic illness such as neuropathy, HIV, cancer or other terminal illness)
•4) Previous reconstructive surgery that would prohibit use of the AKRFX system or compromise the AKRFX surgical technique
•5) Previous lateral meniscectomy greater than 30%
•6) Previous knee osteotomies in the study knee
•7) Previous patellectomy
•8) Gross tibial tubercle deformity
•9) Cruciate ligament instability with Lachman Test, Grade 2 or higher
•10) Posterior Draw Test, Grade 2 or higher
•11) Evidence of Grade 3 or higher lateral compartment osteoarthritis (Kellgren Lawrence Scale)
•12) Evidence of Grade 3 or higher patella osteoarthritis (Kellgren Lawrence Scale)
•13) Proximal tibial width < 64 mm or > 88 mm
•14) Current smoker or quit smoking less than one year ago
•15) Body Mass Index over 35

发起方

iBalance Medical Inc.