Os Calcis Fracture Clinical Trial
Official title:
Surgical vs. Conservative Treatment of Displaced Intra-articular Calcaneal Fractures: A Prospective, Randomized, Controlled Multicenter Trial
Between 1994-98 5 hospitals in Stockholm investigated calcaneal fractures in a randomised
study.
82 patients were included and randomized either to non-surgical treatment or surgical
management with extensile lateral approach and reduction with Internal fixation (ORIF) The
patients were followed and investigated at fixed intervals 2 weeks, 8 weeks, 3 months and 6
months for clinical review. At 1 year and 8-12 years (mean 10 years) post-injury.
Both clinical radiological data were collected and several scores were used. The primary
outcomes scores used were SF-36 and VAS score.
The results after 1 year and mean 10 years are presented.
The study was approved by the local ethical committee. Seven trauma orthopaedic surgeons in
five hospitals in Stockholm were recruited in this RCT, which was conducted between 1994 and
1998. Patients presented with > 2mm DIACFs verified by axial and coronal computerized
tomography (CT) scan were considered for inclusion. Exclusion criteria included peripheral
neuro-vascular disease (signs and symptoms of ischemia or neuropathy), open fractures,
uncontrolled diabetes mellitus and medical contra-indications to surgery.
All centers used the same study protocol. Demographic data were obtained from the patients,
as they deemed eligible to participate in the study. Informed consent was obtained from each
patient. Randomization was carried out by sealed opaque envelope to choose surgical vs.
conservative treatment.
The surgical treatment was carried out within 2 weeks post-injury when the local soft tissue
swelling subsided. Surgery included open reduction using the lateral extensile approach
according to Benirschke (ref) and manipulation of the fragments as described by Soeur and
Remy (ref) to achieve anatomical reduction, which then was fixed by screws, reconstruction
plates or calcaneal plates. Using bone grafts was left to the judgment of the surgeon.
Postoperatively, plain X-ray and CT scan were used to evaluate the quality of fracture
reduction. Sex week's non-weight bearing was advocated for all patients. Range-of-motion
exercises were allowed during this period. Thereafter, the patients had a standardized
physiotherapy regimen with full weight bearing.
The conservative treatment included rest, elevation and non-weight bearing. Early
range-of-motion exercises were encouraged as tolerated. After 6-8 weeks weight bearing was
allowed and shoe modification was provided to those who had hind foot deformities.
No patients were managed with impulse compression therapy.
Patients of both groups were followed-up by treating surgeons at 2 weeks, 8 weeks, 3 months
and 6 months for clinical review. At 1 year and 8-12 years (mean 10 years) post-injury, all
patients were evaluated by unbiased surgeons who were not involved in the treatment of the
patients and they completed the following questionnaires:
1. Primary outcome measures: visual analogue scale (VAS) scoring devised and tested by
Hildebrand et al (ref) and a self-administrated general health outcome form (SF-36) for
physical and mental health.
2. Secondary outcome measures: VAS at rest and on weight bearing (0-10), the American
Orthopaedic Foot & Ankle Society (AOFAS) hindfoot scale and the Olerud-Molander (OM)
score.
The investigators divided each group into two subgroups, younger and older than 50 years to
determine if the results of the outcome measures at 1 year would differ according to the age
of the patients.
During controls, clinical evaluation was carried out to measure the ankle joint and subtalar
joint range of motion and the length and width of the hind foot. The contra-lateral
non-fractured foot was used for comparison. Shoe problems, the outcome of any eventual
postoperative/post-injury complications and workers´ compensation were documented.
Radiological follow-up with axial and coronal CT scan was done at the 1 year and 3 years
visits.
Statistical analysis The SPSS program version 18.0 for personal computers (Chicago,
Illinois) was used for data analysis. The variables of interests were analyzed to determine
the differences using bivariate comparisons. The means with standard deviation (SD) were
measured. The Mann-Whitney test was used for non-parametric data while two-sample t-test was
used for parametric data. A p value of <0.05 was considered significant.
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Observational Model: Case Control, Time Perspective: Prospective