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Chevron osteotomy: immobilisation by cast or walking boot?


- candidate number15728
- NTR NumberNTR4251
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-nov-2013
- Secondary IDsRTPO 910 METC
- Public TitleChevron osteotomy: immobilisation by cast or walking boot?
- Scientific TitleChevron osteotomy for the treatment of hallux valgus - Effectiveness of postoperative immobilisation by a plaster cast or walking boot
- ACRONYM
- hypothesisImmobilisation by means of a plaster cast will result in a better correction and retaining of the hallux valgus correction at one year following chevron osteotomy. Additionally, it is hypothesised that immobilisation by means of a plaster cast will also result in a better recovery of plantar pressure during walking, and a better recovery of physical functioning and health-related quality of life.
- Healt Condition(s) or Problem(s) studiedChevron osteotomy, Hallux valgus, Physical functioning
- Inclusion criteria- at least 18 years old
- mild symptomatic hallux valgus: intermetatarsal 1 and 2 angle (IMA) of < 16 degrees, and a hallux valgus angle (HVA) of < 30 degrees
- Exclusion criteria- Diabetes mellitus
- Rheumatoid arthritis
- Prednison use
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2016
- Target number of participants100
- InterventionsTreatment of the study group (Chevron osteotomy with postoperative immobilisation by means of a plaster cast): Postoperative immobilisation following Chevron osteotomy will be performed by means of a (non-removable) plaster cast, for a period of six weeks. Only partial weightbearing is allowed (only the heel). This plaster cast will be created by a master caster.

Treatment of the control group (Chevron osteotomy with postoperative immobilisation by means of a removable walking boot): Postoperative immobilisation following chevron osteotomy will be performed by means of a removable walking boot, for a period of six weeks. Complete weightbearing is allowed. This walking boot will be created by an orthopedic shoemaker.
- Primary outcomeProportion patients with a loss of more than 5 degrees of the correction of the hallux valgus angle (HVA), one year following surgery
- Secondary outcome- Difference in (the course of regression of the) HAV and intermetatarsal 1 and 2 angle (IMA)
- plantar pressure: peak pressure of eight regions in the forefoot
- Physical functioning
- Health-related quality of life
- Timepoints- Preoperatively
- 6 weeks postoperatively
- 3 months postoperatively
- 6 months postoperatively
- 1 year postoperatively
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD T.M. Raaij, van
- CONTACT for SCIENTIFIC QUERIESDr. I.H.F. Reininga
- Sponsor/Initiator Martini Hospital Groningen
- Funding
(Source(s) of Monetary or Material Support)
Martini Hospital, Department of Orthopaedic Surgery
- PublicationsN/A
- Brief summaryDeformity of the big toe is a common orthopedic problem, and 33% of the general Dutch population has a hallux valgus. This deformity of the big toe can ultimately lead to pain and gait deviations. A symptomatic hallux valgus is often treated surgically, to correct the anatomic deformity. The Chevron osteotomy is a much used surgical technique for this. Postoperative immobilisation can be done by means of a plaster cast or a removable walking boot. An advantage of the walking boot is that it is more comfortable compared to a plaster cast. However, it is unknown whether immobilisation by means of the walking boot results in a remained correction of the hallux valgus. The hallus valgus correction might be better preserved by means of a plaster cast, becaus the reefed capsule gets a better change for scarring in the by surgery obtained position. To date, there is a lack of studies in which the effectiveness of the two types of postoperative immobilisation following Chevron osteotomy - a plaster cast or a removable walking boot - has been compared.

Primary aim of the study is to compare the preservation of the correction of hallux valgus angle by means of a Chevron osteotomy with postoperative immobilisation by means of a plaster cast or a removable walking boot, one year following surgery. Secondary aims are to compare the effectiveness of the immobilisation by means of a plaster cast or a walking boot for the recovery of plantar pressure during walking, and recovery of physical functioning and health-related quality of life.

A prospective randomised controlled trial will be conducted. Two types of postoperative immobilisation following Chevron osteotomy wil be compared. The control group will receive postoperative immobilisation by means of a removable walking boot. The study group will receive postoperative immobilisation by means of a (non-removable) plaster cast. Measurements will take place preoperatively, and 6 weeeks, 3, 6 and 12 months postoperatively.
- Main changes (audit trail)
- RECORD20-nov-2013 - 18-dec-2013


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