The present study is designed 1) to compare the long-term survival using the recurrence rate of hallux valgus in the scarf and chevron osteotomy group; 2) to compare the long-term results with the results at 27 months; and 3) to asses patients* view…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this follow-up study will be the recurrence rate of
hallux valgus and reoperation rate of the same toe for HV. Recurrence of HV is
defined as a HVA > 15 degrees with a symptomatic bunion at physical examination
[5,16]
Secondary outcome
The secondary outcome includes patients satisfactory and the results from the
SF-36, AOFAS rating system, MOXFQ and radiographic measurements IMA and HVA.
Patients satisfactory will be defined as less than 9 points in total on the
three five-points satisfactory questions in the general questionnaire.
Background summary
One of the most common foot deformities. Its prevalence is higher in females
and increasing with age. The etiology is believed to be multifactorial in which
both extrinsic factors like high heel shoes as intrinsic factors such as
genetics contribute to the pathophysiology. Numerous non-operative and more
than 100 operative techniques have been described in literature with operative
treatments varying from distal soft tissue release to proximal and distal
osteotomies. Two widely used and accepted treatments in HV corrections are the
chevron and the scarf osteotomy.
Study objective
The present study is designed 1) to compare the long-term survival using the
recurrence rate of hallux valgus in the scarf and chevron osteotomy group; 2)
to compare the long-term results with the results at 27 months; and 3) to asses
patients* view on their treatment and current situation including patient
reported outcome measures.
Study design
The present study is a follow-up of a RCT carried out at the Atrium-Orbis
Medical Center location Sittard in the Netherlands (previously known as
Maaslandziekenhuis Sittard) published by Deenik et al. in 2007. One hundred and
eight feet in 96 patients were included in the primary study and randomized
into the scarf (n=49) or chevron (n=47) osteotomy group. Follow-up moments were
pre-operative and at 3, 6, 12 and 27 months.
The inclusion criteria for present study will be patients who had participated
in the previous study. Patients who did not want to contribute were excluded
from follow-up.
The primary outcome of this follow-up study will be the recurrence rate of
hallux valgus and reoperation rate of the same toe for hallux valgus.
Recurrence of hallux valgus is defined as a HVA > 15 degrees with a symptomatic
bunion at physical examination.
The secondary outcome include patients satisfactory and the results from the
SF-36, AOFAS rating system, MOXFQ and radiographic measurements IMA and HVA.
Patients satisfactory was defined as less than 9 points in total on the three
five-points satisfactory questions in the general questionnaire.
Study burden and risks
Patients will be asked to visit the hospital once for filling in 4
quesionnaires and at the same visit physical examination will take place (in
which one of the authors inpects the foot and passively moves the MTP joint).
There will also be one conventional x-ray of the foot.
Our hospital will take care of the costs of the outpatient contact and x-ray.
Radiation produced by conventional x-ray used in present study is negligible.
Everybody in a normal environment receives röntgen radiation on a daily basis.
This is called background radiation and it is expressed in millisievert (mSv).
An average person in the Netherlands receives 2 mSv by radiation from the soil,
from space an surrounding materials like concrete. People living on higher
altitudes can even receive 10 mSv per year. The radiation that somebody
receives when a conventional x-ray is made is similar to a flight to Japan.
This is about 0.1 mSv and considered safe.
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
Participated in the original RCT by Deenik et al. (2007)
Exclusion criteria
Not willing or able to contribute to the 12 year follow-up.
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 | NL52911.096.15 |