Open Reduction and Internal Fixation versus Casting for Highly comminuted and Intraarticular Fractures of the Distal Radius - ORCHID

niversitätsklinikum Ulm0 个研究点目标入组 183 人开始时间: 2008年11月26日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Men and women >65 years with radiologically confirmed, isolated, closed, comminuted intraarticular distal radial fractures (AO/ASIF 23 C1, C2, C3) (according to surgeon?s judgment)

•Patients with an obvious need for surgical treatment, i.e., open fractures, severe soft tissue damage (>G1 according to Oestern and Tscherne), and a pathological fracture because of malignant disease will be excluded from this trial.
•Written informed consent by patients is mandatory, and any lack of consent will exclude subjects from trial participation. Subjects suffering from progressive dementia or other psychiatric diseases, or those who are unwilling to cooperate and thus jeopardize the success of follow-up will be excluded as well. If providers foresee a patient is inability to attend the 12-months follow-up evaluation because of severe frailty or other reasons, the subject will not be offered trial participation.
•Both in- and exclusion criteria define a typical target population with i. a high incidence of wrist fractures, ii. therapeutic uncertainty (equipoise) about the benefit-risk-ratio of operative and non-operative fracture management, and iii. a considerable likelihood of sustaining long-term sequelae from inappropriate treatment.

发起方

niversitätsklinikum Ulm