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Feasibility study of an orthosis for treatment of a Clubfoot

Feasibility study of an orthosis for treatment of a Clubfoot - Orthosis for treatment of a clubfoot

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52544
Enrollment
10
Registered
2019-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

clubfoot

Interventions

A brace was realized that can treat a clubfoot and can be removed temporarily for diaper change or a bath. The force applied on the foot by the brace should be enough to correct the deformations of

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • A moderate to severe clubfoot deformity according to the Dimeglio scoring system (grade II or III) • Start of the Ponseti treatment within 2 weeks after birth • No other deformities of the foot or leg • Written informed consent

Exclusion criteria

Exclusion criteria: • previously treated by the Ponseti method • characterised by grade IV according to the Dimeglio scoring system • have other health complications, because they could interfere with the results of the brace

Design outcomes

Primary

MeasureTime frame
The primary outcomes are amount of correction defined by the Dimeglio and Pirani score, time needed for treatment and malfunctioning of the brace.

Secondary

MeasureTime frame
The secondary outcome measure is physical complications of the treatment, caused by the brace.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)