|- candidate number||15728|
|- NTR Number||NTR4251|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-nov-2013|
|- Secondary IDs||RTPO 910 METC|
|- Public Title||Chevron osteotomy: immobilisation by cast or walking boot?|
|- Scientific Title||Chevron osteotomy for the treatment of hallux valgus - Effectiveness of postoperative immobilisation by a plaster cast or walking boot|
|- hypothesis||Immobilisation 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) studied||Chevron 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-jan-2016|
|- Target number of participants||100|
|- Interventions||Treatment 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 outcome||Proportion 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 site||N/A|
|- CONTACT FOR PUBLIC QUERIES||PhD T.M. Raaij, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. I.H.F. Reininga|
|- Sponsor/Initiator ||Martini Hospital Groningen|
(Source(s) of Monetary or Material Support)
|Martini Hospital, Department of Orthopaedic Surgery|
|- Brief summary||Deformity 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)|
|- RECORD||20-nov-2013 - 18-dec-2013|