Knee osteoarthritis Injection Therapy (KNiT) trial - KNiT

Beacon Hospital0 个研究点目标入组 135 人开始时间: 2021年2月5日最近更新: 2021年6月7日

适应症

试验速览

暂无简介。

•To be eligible for inclusion, each subject must meet each of the following criteria at Screening (Visit 1) and must continue to fulfil these criteria at Baseline (Visit 2):
•-Age over 30 years
•-Mean VAS pain score of >40 of 100 (worst possible pain) over the course of 7 days during the previous month
•-OA diagnosed by the American College of Rheumatology criteria
•-Grade 1-3 radiographic OA as defined by the Kellgren-Lawrence classification
•-Unilateral symptoms
•-Patient is able to complete trial procedures and complete informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 135
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Knee instability during physical examination (grade II or III)
•-Pre-treatment VAS pain score of <40 of 100
•-Major axial deviation (>10 degrees of valgus or varus deviation)
•-Bilateral symptomatic lesions
•-Current use of anticoagulant medications or NSAIDs used in the 5 days before blood donation
•-Recent intra-articular injection of corticosteroids and prior treatment with HA or PRP in the past 6 months
•-Symptomatic osteoarthritis in the contralateral knee
•-Allergy/sensitivity to study medications or their ingredients
•-Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the initial treatment period
•-Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
•-Known history of, or documented positive hepatitis B or C or HIV infection

发起方

Beacon Hospital