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Open Reduction Internal Fixation of Calcaneus Fractures With and Without Bone Graft (CALCANEUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00582686
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE December 28, 2007
Last Update Posted Date October 1, 2013
Study Start Date  ICMJE May 2000
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2007)
Union and healing of Calcaneus Fracture [ Time Frame: 3 month to 12 month healing period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Reduction Internal Fixation of Calcaneus Fractures With and Without Bone Graft
Official Title  ICMJE Prospective Comparison of Open Reduction Internal Fixation of Calcaneus Fractures With and Without Tricortical Iliac Crest Bone Grafting
Brief Summary The purpose of this study is to compare patient functional outcomes for surgical fixation of calcaneus fractures with and without tricortical iliac crest bone grafting
Detailed Description This study was designed as a randomized, prospective evaluation of patients who have sustained an intra-articular calcaneus fracture that requires open reduction with internal fixation as the preferred method of treatment. Patients who desire to participate in this study will be randomized into one of two groups. Group A will be made up of patients that undergo open reduction with internal fixation and Tricortical iliac crest bone grafting. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting. All other surgical techniques and management of the fracture and patient will remain unchanged.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Calcaneus Fractures
Intervention  ICMJE
  • Procedure: ORIF of Calcaneus with bone grafting
    The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) and Tricortical Iliac Crest bone grafting
  • Procedure: ORIF of Calcaneus without bone grafting
    The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting)
Study Arms  ICMJE
  • Active Comparator: ORIF with Bone Grafting
    This study will be designed as a randomized, prospective, blinded evaluation of patients who have sustained an intra-articular calcaneous fracture that would require open reduction with internal fixation as the preferred method of treatment. Group A will be made up of patients that undergo ORIF and Tricortical iliac crest bone grafting.
    Intervention: Procedure: ORIF of Calcaneus with bone grafting
  • Active Comparator: ORIF without Bone Grafting
    This study will be designed as a randomized, prospective, blinded evaluation of patients who have sustained an intra-articular calcaneous fracture that would require open reduction with internal fixation as the preferred method of treatment. Group B will consist of patients that undergo open reduction with internal fixation without bone grafting
    Intervention: Procedure: ORIF of Calcaneus without bone grafting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2007)
49
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • intra-articular calcaneus fractures requiring open reduction and internal fixation
  • Adult patient (19 years or older)
  • Mental capacity to comply with post-operative regimen, evaluation and data collection

Exclusion Criteria:

  • non-operative fractures for primary or secondary reasons
  • prior surgery to the hindfoot of the involved lower extremity
  • inability to comply with post-operative regimen, evaluation and data collection
  • inability or unwillingness to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00582686
Other Study ID Numbers  ICMJE F990923008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rena L Stewart, MD The University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP