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Surgical vs Conservative Treatment of Displaced Intra-articular Calcaneal Fractures: A Prospective RCT

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ClinicalTrials.gov Identifier: NCT01615744
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
Agren, Per-Henrik, M.D.

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.


Condition or disease Intervention/treatment
Os Calcis Fracture Procedure: Open Reduction Internal Fixation Procedure: Non-surgical management

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Surgical vs. Conservative Treatment of Displaced Intra-articular Calcaneal Fractures: A Prospective, Randomized, Controlled Multicenter Trial
Study Start Date : December 1993
Primary Completion Date : January 1994
Study Completion Date : December 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Group/Cohort Intervention/treatment
Surgical ORIF calcaneal fx Procedure: Open Reduction Internal Fixation
Lateral approach through extensile lateral incision ( Benirschke), Reduction ( Soeur et Remy) and internal fixation with lateral plating with or without bone graft
Other Name: Surgery
Conservative treatment calcaneal fx Procedure: Non-surgical management
Early active exercises and elevation to decrease swelling
Other Names:
  • No surgery
  • early movement
  • decreasing swelling



Primary Outcome Measures :
  1. SF-36 [ Time Frame: 1 year and 10 years post injury ]
    The investigators anticipate that there might be a change over time and want to investigate and describe it

  2. VAS-score (calcaneal fractures) /Hildebrand, Buckley [ Time Frame: 1 year and 10 years post injury ]
    The investigators anticipate that there might be a change over time and want to investigate and describe it


Secondary Outcome Measures :
  1. VAS of pain at rest and exertion [ Time Frame: 2 weeks,6 weeks,12 weeks,1 year, 3 years and 10 years post injury ]
    The investigators anticipate that there might be a change over time and want to investigate and describe it

  2. AOFAS hindfoot scale [ Time Frame: 1 year and 10 years post injury ]
    The investigators anticipate that there might be a change over time and want to investigate and describe it

  3. Olerud-Molander score [ Time Frame: 1 year and 10 years post injury ]
    The investigators anticipate that there might be a change over time and want to investigate and describe it



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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615744


Locations
Sweden
Stockholms Fotkirurgklinik, Sophiahemmet
Stockholm, Sweden, 11486
Sponsors and Collaborators
Agren, Per-Henrik, M.D.
Investigators
Principal Investigator: Per-Henrik Aagren, MD Consultant Orthopaedic Surgeon

Responsible Party: Agren, Per-Henrik, M.D.
ClinicalTrials.gov Identifier: NCT01615744     History of Changes
Other Study ID Numbers: CalcanealfxRCT
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012

Keywords provided by Agren, Per-Henrik, M.D.:
calcaneal fractures
surgical treatment
conservative treatment
VAS scoring
SF-36
AOFAS
Olerud-Molander score
outcome

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries