The aim of the study is to determine the difference in effectiveness in the treatment of a hallux valgus correction with 2 weeks cast versus pressure bandage treatment with 2 weeks, both followed by 4 weeks with a spica and Post-op shoe.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the VAS satisfaction score
Secondary outcome
Secondary endpoints are: VAS pain score, and recurrence hallux valgus, Position
sesamoidea, wound (redness, infection, blisters), MTP1 joint function, AOFAS
hallux score, Complications
Background summary
Hallux valgus is a deformity of the first ray. The metatarsal 1 is directed
medially, while dig 1 is directed laterally. This creates a bunion at the level
MTP joint on the medial side of the foot. This may lead to a bursitis. The
deformity and bursitis can cause pain, especially when wearing shoes. In
addition, the deformity can cause aesthetic complaints.
The operation is aimed at pain reduction and a better fit in footwear.
There is little / no literature available on the standard treatment after
surgical correction of the hallux valgus deformity. This varies from shoe cast
to a spica with a post-op shoe. With also variations in duration of treatment,
such as 2weeks no weightbearing versus 4 weeks no weightbearing. It also
appears that the risk of recurrence and complications is independent of the
chosen treatment.
The correction is a fixed osteosynthesis, thereby it is to be expected that
immobilization with a cast is not necessary. In many other hospitals pressure
bandage is already the standard treatment.
In the manuals foot and ankle surgery a bandage with use of a wedge shoe is
recommended as treatment with no weightbearing the first 2-4 weeks. Cast Shoe
treatment only if the osteotomy or fixation should be protected.
There are no recent publications on recurrence rates, wound healing disorders
and patient satisfaction associated with comparative studies on pressure
bandage versus cast.
However, there is a study of the after treatment of a Lapidus procedure,
herein is found that only a bandage with a wegde schoe is sufficient
Study objective
The aim of the study is to determine the difference in effectiveness in the
treatment of a hallux valgus correction with 2 weeks cast versus pressure
bandage treatment with 2 weeks, both followed by 4 weeks with a spica and
Post-op shoe.
Study design
It is a Randomised Controlled Trial.
118 patients : 59 patients cast (control group) given after surgery and 59
patients pressure bandage (intervention) after surgery
The 14th day postoperatively, the patients in both groups return to the cast
clinic to remove the pressure bandage / cast and there will be a wound
inspection by the doctor, also the stitches are removed. After this, every
patient has a spica applied for 4 weeks. Postoperatively, the patient is asked
at each control pain and satisfaction scores, this can be done using validated
assessment tools. 12 weeks postoperatively and 1 year postoperatively, the
function of the MTP1 joint is re-examined and at the last audit 1 year
postoperatively the AOFAS Hallux score will be recalculated.
Radiographs are preoperatively, 6 and 12 weeks postoperatively and 1 year
postoperatively made**.
Intervention
Group 1 receives a cast after the operation (standard)
Group 2 will receive a pressure bandage after surgery (intervention)
Study burden and risks
Risks, patients are not at extra risk when participating in the study. The
risks that could arise are related to the surgery. These risks one runs even if
one does not join the study
Burden: The extra burden on participants is completing questionnaires and
keeping a pain and satisfaction diary the first 14 days postoperatively.
Spaarnepoort 1
Hoofddorp 2134TM
NL
Spaarnepoort 1
Hoofddorp 2134TM
NL
Listed location countries
Age
Inclusion criteria
primary, elective hallux valgus correction in the form of: Akin, scarf osteotomy or Chevron osteotomy
>18 year
signed informed consent
understand / read Dutch language regarding completion questionnaire
Exclusion criteria
no signed informed consent
patients undergoing hallux valgus correction and also a hammer toe correction with k-wires are used
inability to use two crutches to mobilize
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 | NL39794.094.12 |