S-guided Percutaneous needle tenotomy in Patients with Lateral Elbow Tendinopathy: A multicenter Randomized Controlled Trial - PUNT

Sint Maartenskliniek0 个研究点目标入组 114 人开始时间: 2018年8月9日最近更新: 2018年10月1日

适应症

试验速览

暂无简介。

•Age between 18 and 65 years
•Pain in the elbow present for more than 12 months, unresponsive to conservative treatment
•Sonographically proven tendinopathy (hypervascularisation, deep tendon calcifications, hypoechogenic tendon, erosive cortex)
•Concordant pain during compression with a US Probe in the region of the extensor tendons
•Is able to give informed consent
•Is instructable to follow the exercises
•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 114
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Surgery related to the lateral elbow tendinopathy, including Needle Aspiration of Calcific Deposits (NACD)
•Systemic joint disease such as rheumatoid arthritis etc.
•Rupture or clefts >1cm of the extensor tendons
•Detachment of extensor tendons or tears in collateral ligament
•Contraindication for lidocaïne in accordance to the SPC
•Pregnancy
•Use of anti-inflammatory drugs, such as NSAIDs, steroids, methotrexate, anti-TNF, azathioprine
•Use of anticoagulant drugs which is bridged with acetylsalicylate acid
•Physical, emotional or neurological conditions that would compromise the patient’s compliance with postoperative rehabilitation protocol follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple Sclerosis, etc.)

发起方