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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00018817
Enrollment
150
Registered
2019-12-06
Start date
2019-11-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent dislocation, ankle, foot and toes M24.47

Interventions

Group 1: Treatment according to observational study: Proband is provided with 2 ankle supports (FastProtect Malleo) and uses it according to the intended purpose. During the one-year study period, vis
this serves as an intraindividual control. The untreated joint serves as a control in the event that only 1 joint is treated. Here visits and questionnaires are carried out analogous to arm 1.

Sponsors

Julius Zorn GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Reduction of the frequency of OSG distortions in training and competitions for competitive athletes after 9 months

Secondary

MeasureTime frame
-Reduction of the frequency and severity of OSG distortions in comparison with a FU period of 3 and 12 months - Reduction of the severity of OSG distortions compared to the time period of one year - Missing disturbances during sports activities / training - improved player behavior / improved performance - Support in the training of proprioceptors - Compliance and comfort for regular workouts and competitions satisfactory - Satisfactory benefit/risk analysis

Countries

Germany

Contacts

Public ContactCaroline Schmidt-Lucke

Mediacc GmbH

Caroline.Schmidt-Lucke@mediacc.de+49-30-52104480

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026