Prospective, open, controlled, single-blind, multicenter study to demonstrate the effectiveness of the innovative ankle support FastProtect Malleo for secondary prevention after distortion of the upper ankle in competitive athletes - AWB-FPM-I.1

Julius Zorn GmbH0 个研究点目标入组 69 人开始时间: 2019年12月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Competitive athletes aged 18 and over, male or female
•- Repeated OSG distortions on one page in the last 2 years
•- Subjectively perceived instability or twisted events (giving way) or fear of giving way
•- evidence of a mechanical capsule band instability of the OSG within the framework of a
•clinical examination (talus advancement and talus tilting);
•- Rehabilitation or training for OSG instability in the last 3 months;
•- Ability to consent;
•- Signed declaration of consent after clarification

•Use of tibia protectors with hard covering of the tibia including the external ankle
•painful gait or restricted movement
•Surgical intervention on the lower extremities in the last 12 months
•Acute OSG distortion in the last 3 months
•Fractures or traumatic injuries of the lower extremities in the anamnesis
•Symptomatic damage to adjacent joints (knee and hip)
•Neurological disorders of the lower extremities
•vestibular or other balance disorder
•Rheumatic disease
•Skin diseases or skin irritations in the supplied area
•Skin irritations in the supplied area
•open injury, vascular or nerve injury
•syndesmosis rupture
•Arterial or venous circulatory disorders of the affected extremity
•Postthrombotic conditions
•lymph drainage disorders
•Congenital deformities of the foot
•Active Infectious Disease
•systemic diseases, autoimmune, rheumatic or tumor diseases, diabetes mellitus
•Acute and degenerative lumbar diseases
•Generalized hypermobility
•Pregnancy or breastfeeding mothers
•Poor compliance or mental disorders
•incapacity to consent
•Participation in another clinical examination

发起方

Julius Zorn GmbH