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Research on the difference in effectiveness between the treatment with piaster versus pressure bandage after hallux valgus correction.


- candidate number14542
- NTR NumberNTR3909
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mrt-2013
- Secondary IDsM012-012 METC
- Public TitleResearch on the difference in effectiveness between the treatment with piaster versus pressure bandage after hallux valgus correction.
- Scientific TitleResearch on the difference in effectiveness between the treatment with piaster versus pressure bandage after hallux valgus correction.
- ACRONYMHV Study
- hypothesisThe hypothesis: We expect no differences in primary and secondary outcome measures between the treatment with 2 weeks of piaster versus 2 weeks of pressure bandage after a hallux valgus correction, both followed by 4 weeks of a toe spica with a Post-op shoe.
- Healt Condition(s) or Problem(s) studiedHallux valgus, Post operative
- Inclusion criteria1. Age 18 and over who underdog a primary hallux valgus correction in the form of: scarf osteotomy, chervron osteotomy or Akin. Based on the most performed hallux valgus corrections in the Spaarne Hospital;
2. Signed informed consent;
3. Subject must be able to speak, read en write the Dutch language.
- Exclusion criteria1. Subjects that undergo a hallux valgus correction in combination with a hammertoe correctie with a k-wire;
2. Subjects without signed informed consent;
3. Inability to mobilize with 2 crutches.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate31-dec-2013
- Target number of participants118
- Interventions2 groups:
Group 1: Post-operative 2 weeks a plaster with a post-op shoe.
Group 2: Post-operative 2 weeks a pressure bandage with a post-op shoe.
Subjects from both groups will get a toe spica with a post-op shoe after the first 2 weeks for another 4 weeks.
12 weeks post-operative and 1 year post-operative the function of MTP1 will be tested. And 1 year post-operative the AOFAS hallux score will be measured as well.
- Primary outcomeThe primary endpoint is the VAS satisfaction score.
- Secondary outcomeSecondary endpoints are: VAS pain score, the correction and recurrence, position of the sesamoidea, wound healing/problems (redness, infection, blisters), function MTP1 joint, AOFAS hallux score and complications.
- TimepointsFirst visit is on the out-patient clinic, second visit is the day of operation. All subject will stay in the hospital for 1 night.
Group 1: Post-operative 2 weeks a plaster with a post-op shoe.
Group 2: Post-operative 2 weeks a pressure bandage with a post-op shoe.
Subjects from both groups will get a toe spica with a post-op shoe after the first 2 weeks on the out patient plaster clinic for another 4 weeks.
12 weeks post-operative and 1 year post-operative the function of MTP1 will be tested. And 1 year post-operative the AOFAS hallux score will be measured as well.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Famke J.M. Scheerder
- CONTACT for SCIENTIFIC QUERIES Famke J.M. Scheerder
- Sponsor/Initiator Spaarne Hospital
- Funding
(Source(s) of Monetary or Material Support)
Spaarne Hospital
- PublicationsN/A
- Brief summaryThere is no consensus about the best post-operative treatment after a hallux valgus correction. We started a research on the difference in effectiveness between the treatment with piaster versus pressure bandage after hallux valgus correction with the hypothesis that there is no difference. We want to prove that on the basis of primary and secondary endpoints: VAS satisfaction score,VAS pain score, the correction and recurrence, position of the sesamoidea, wound healing/problems (redness, infection, blisters), function MTP1 joint, AOFAS hallux score and complications.
- Main changes (audit trail)
- RECORD18-mrt-2013 - 26-mrt-2013


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