Primary aim of the study: 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.…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter is the proportion patients with a loss of more than 5
degrees of the correction of the hallux valgus angle (HVA), one year following
surgery.
The HVA is measured at standard weigtbearing X-rays of the foot by means of a
reliable measurement protocol. These X-rays are part of the standard clinical
follow-up after Chevron osteotomy. They are made preoperatively, and one day, 6
weeks, 6 and 12 months postoperatively. A loss of more than 5 degrees of the
correction of the hallux valgus angle is considered a clinically relevant loss.
Secondary outcome
- Difference in (the course of regression of the) HVA and Intermetatarsal 1 and
2 angle (IMA)
- Plantar pressure:
- peak pressure of eight regions of the forefoot
Plantar pressure during walking will be assessed preoperatively and 3, 6 and 12
months postoperatively. Since the postoperative immobilisation will take 6
weeks, the first postoperative measurement will take place at 3 months
following surgery. Plantar pressure will be measured by means of insoles which
contain pressure sensors, the Pedar Insole system® (Novel, München, Duitsland).
The Pedar Insole system is a wireless system, containing insoles that are
connected to a data-receiver that is carried on the waist. To exclude variation
in results because of differences in shoes, standardizes shoes will be used for
the measurements.
- Physical functioning
- Health-related quality of life.
Physical functioning and health-related quality of life will be assessed by
means of questionnaires. These questionnaires will be assessed preoperatively,
and 6 weeks, 3, 6 and 12 months postoperatively. Physical functioning will be
measured by means of the Foot Function Index (FFI). The FFI consists of 23
items, divided into 3 subscales. Health-related quality of life will be
measured by means of the EQ-5D, consisting of 5 questions.
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
hallux valgus correction might be better preserved by means of a plaster cast,
because the reefed capsule gets a better chance 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.
Study objective
Primary aim of the study: 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
quality of life.
Study design
A prospective randomised controlled trial will be conducted. Two types of
postoperative immobilisation following Chevron Osteotomy will 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 plaster cast. Measurements will take place preoperatively and 6
weeks, and 3, 6 and 12 months postoperatively. The study will be conducted at
the Department of Orthopedic Surgery of the Martini Hospital Groningen.
Intervention
The type of postoperative immobilisation will be determined by means of
randomisation. The anesthetic and pain protocols will be standardized.
Discharge criteria will also be the same in both study groups.
Treatment of the study group (Chevron osteotomy with postoperative
immobilisation by means of a plaster cast):
Postoperative immobilisation will be performed by means of a (non-removable)
plaster cast, for a period of six weeks. Only partial weigthbearing 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 will be performed by mean 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.
Study burden and risks
Since both types of postoperative immobilisation are usual care for the
postoperative treatment of Chevron osteotomy, no additional risks are
associated with participation of the study. No extra X-rays will be made, since
the X-rays that are part of the clinical follow-up of Chevron osteotomy are
used. No additional risks are associated with the plantar pressure measurements
by means of the Insole system.
Van Swietenplein 1
Groningen 9728 NT
NL
Van Swietenplein 1
Groningen 9728 NT
NL
Listed location countries
Age
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
Patients with:
- Diabetes mellitus;
- Rheumatoid arthritis;
- Predison 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 |
|---|---|
| CCMO | NL46732.099.13 |
| Other | NTR15564 |