A prospective and observational clinical investigation evaluating the clinical outcomes of unstable distal radius fractures treated by the dynamic external fixator Galaxy Wrist - OCI 1401

Orthofix Srl, , Bussolengo (Verona), Italy0 个研究点目标入组 120 人开始时间: 2014年9月25日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•INCLUSION CRITERIA
•Patient will be eligible for inclusion in the investigation if he/she:
•- is at least 18 years old at time of ICF signature;
•- compliant to sign ICF;
•- has a fresh (= 14 days since the time of the injury), intra- or extra-articular, unstable Distal Radius Fracture(s) (DRF(s)) with or without soft tissue damage requiring a surgical management;
•- has a regular indication for surgical intervention with Galaxy Wrist, in the bridging configuration, up to the surgeon decision.

•EXCLUSION CRITERIA
•Patient will be excluded from participation in the investigation if he/she:
•- has bilateral DRFs;
•- has carpal combined injuries/fractures;
•- has rheumatoid arthritis;
•- has previous DRF/arthrodesis;
•- has a medical condition that is a contraindication according to the manufacturer instruction for use;
•- has suspected foreign body sensitivity or declared allergy to the device components which contact the patient;
•- has any conditions which in the Investigator’s opinion may interfere with the study execution or due to which the patient should not participate for safety reasons;
•- is unwilling or incapable of following postoperative care instructions due to mental or physiological condition;
•- is assuming a not permitted concomitant medication which cannot be safely stopped;
•- is having a concomitant treatment with a not permitted devices which cannot be safely removed;
•- is participating other clinical trials or took part to a clinical study in the last 3 months;
•- is likely to be lost to follow up.

发起方

Orthofix Srl, , Bussolengo (Verona), Italy