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Functional outcome of clubfeet using a new type of brace.

To Advance is to Move; Functional outcome of conservative treated clubfeet using a fully dynamic brace (Dynko brace).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20366
Enrollment
30
Registered
2009-09-24
Start date
2009-01-06
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

clubfeet, clubfoot, dynamic brace, Ponseti. klompvoeten, dynamische brace

Interventions

All clubfeet are treated with serial casting according to Ponseti. After correction of the foot, this correction is maintained using a fully dynamic brace (Dynko-brace). At day 1-10 after birth clubfe

Sponsors

AGP van Ruiten/ dr. R.H.G.P. van Erve
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with clubfeet born in the referral area of the Deventer Ziekenhuis are selected for this study. There is a intention to treat. That means all patients will undergo at start the same treatment. That is, if conservative treatment is possible.

Exclusion criteria

Exclusion criteria: As mentioned above, all patients with clubfeet will be included. However, patients who do not respond to conservative treatment with manipulation and plaster correction, and therefore need surgery will be identified. Also, a subgroup will be made with patients with a neuromuscular condition or a syndrome. Patients where treatment is not started within 10 days after birth will be excluded. Patients who will not take part of this study will also be grouped and followed throughout this study.

Design outcomes

Secondary

MeasureTime frame
Secondary endpoint is failure of maintaining correction using the Dynko brace. Non-compliance will also be a secondary endpoint.

Primary

MeasureTime frame
The main study endpoint is at age 4 years. This will be the follow-up for this research.

Contacts

Public ContactA.G.P. Ruiten, van

Papingastins 5

spockje@hotmail.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)