Surgical vs Conservative Treatment of Displaced Intra-articular Calcaneal Fractures: A Prospective RCT
Condition: Os Calcis Fracture
MeSH terms: Fractures, Bone
Study type: Observational

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.
    

Intervention name(s): Open Reduction Internal Fixation; Non-surgical management
Intervention type(s): Procedure; Procedure
Intervention description(s): Lateral approach through extensile lateral incision ( Benirschke), Reduction ( Soeur et Remy) and internal fixation with lateral plating with or without bone graft; Early active exercises and elevation to decrease swelling
Other intervention name(s): Surgery; No surgery; early movement; decreasing swelling
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
      
Keywords: calcaneal fractures; surgical treatment; conservative treatment; VAS scoring; SF-36; AOFAS; Olerud-Molander score; outcome