Clinical trial NCT01615744: Surgical vs Conservative Treatment of Displaced Intra-articular Calcaneal Fractures: A Prospective RCT
Official title: Surgical vs. Conservative Treatment of Displaced Intra-articular Calcaneal Fractures: A Prospective, Randomized, Controlled Multicenter Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Os Calcis Fracture
Keywords: calcaneal fractures
surgical treatment
conservative treatment
VAS scoring
SF-36
AOFAS
Olerud-Molander score
outcome
Lead sponsor: Agren, Per-Henrik, M.D.
Sponsor class: INDIV
First posted: 2012-06-11
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between 1994 and 1998. Patients presenting at 5 hospitals in Stockholm after trauma resulting in a fracture with \> 2mm Dislocated Intraarticular Calcaneal Fractures (DIACFs) verified by axial and coronal computerized tomography (CT) scan were considered for inclusion

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients presented with \> 2mm DIACFs verified by axial and coronal computerized tomography (CT) scan were considered for inclusion

Exclusion Criteria:

* Peripheral neuro-vascular disease (signs and symptoms of ischemia or neuropathy), open fractures, uncontrolled diabetes mellitus and medical contra-indications to surgery.

Primary outcomes:
measure: SF-36
timeFrame: 1 year and 10 years post injury
measure: VAS-score (calcaneal fractures) /Hildebrand, Buckley
timeFrame: 1 year and 10 years post injury
Secondary outcomes:
measure: VAS of pain at rest and exertion
timeFrame: 2 weeks,6 weeks,12 weeks,1 year, 3 years and 10 years post injury
measure: AOFAS hindfoot scale
timeFrame: 1 year and 10 years post injury
measure: Olerud-Molander score
timeFrame: 1 year and 10 years post injury
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholms Fotkirurgklinik, Sophiahemmet
Study officials:
affiliation: Consultant Orthopaedic Surgeon
name: Per-Henrik Aagren, MD
role: PRINCIPAL_INVESTIGATOR
References: