Dynamic splinting for hallux valgus – a prospective randomized study

Phase 4

• Conditions: M20.1; Hallux valgus (acquired)

• Registration Number: DRKS00013920
• Lead Sponsor: Orthopädische Klinik der MHH am DIAKOVERE Annastift

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-12-05
• Study Start: 2018-01-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

symptomatic hallux valgus
wear time of the splint for at least 3 months

Exclusion Criteria

hindfoot deformities,
degenerative changes of the MTP 1,
preoperated hallux valgus,
hereditary soft-tissue disease,
inflammatoric skin disease,
circulatory disorder,
polyneuropathy and
BMI > 40

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
After a treatment of at least 3 months with the halluxsan Hallux valgus splint the on a a.p. foot x-ray measured Hallux valgus angle shows a reduction.

Secondary Outcome Measures

Name	Time	Method
After a treatment period of at least 3 months there is a pain reduction, measured on a NRS (Numeric Rating Scale), compared to the preintervention state.