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
- Conditions
- Recurrent dislocation, ankle, foot and toesM24.47
- Registration Number
- DRKS00018817
- Lead Sponsor
- Julius Zorn GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 69
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of the frequency of OSG distortions in training and competitions for competitive athletes after 9 months
- Secondary Outcome Measures
Name Time Method -Reduction of the frequency and severity of OSG distortions in comparison with a FU period of 3 and 12 months<br><br>- Reduction of the severity of OSG distortions compared to the time period of<br>one year<br><br>- Missing disturbances during sports activities / training<br><br>- improved player behavior / improved performance <br><br>- Support in the training of proprioceptors<br><br>- Compliance and comfort for regular workouts and competitions satisfactory<br><br>- Satisfactory benefit/risk analysis