No registrations found.
ID
Source
Health condition
- Hallux valgus
- chevron osteotomy
- immobilisation
- plantar pressure
Sponsors and support
Martini Hospital Groningen
P.O. Box 30033
9700 RM Groningen
Martini Hospital Groningen
P.O. Box 30033
9700 RM Groningen
Intervention
Outcome measures
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
Background 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.
Study objective
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.
Study design
- Preoperatively
- 6 weeks postoperatively
- 3 months postoperatively
- 6 months postoperatively
- 1 year postoperatively
Intervention
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.
Department of Orthopaedic Surgery,
P.O. Box 2040
T.M. Raaij, van
Dr. Molewaterplein 40
Rotterdam 3000 CB
The Netherlands
t.vanraaij@chello.nl
Department of Orthopaedic Surgery,
P.O. Box 2040
T.M. Raaij, van
Dr. Molewaterplein 40
Rotterdam 3000 CB
The Netherlands
t.vanraaij@chello.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4106 |
NTR-old | NTR4251 |
Other | METC : RTPO 910 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |