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

Primary Purpose

Calcaneus Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ORIF of Calcaneus with bone grafting
ORIF of Calcaneus without bone grafting
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcaneus Fractures focused on measuring Calcaneus Fractures, Iliac Crest Bone Grafting, Open Reduction & Internal Fixation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at Birmingham, Orthopaedic Trauma

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ORIF with Bone Grafting

ORIF without Bone Grafting

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Union and healing of Calcaneus Fracture

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
September 28, 2013
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00582686
Brief Title
Open Reduction Internal Fixation of Calcaneus Fractures With and Without Bone Graft
Acronym
CALCANEUS
Official Title
Prospective Comparison of Open Reduction Internal Fixation of Calcaneus Fractures With and Without Tricortical Iliac Crest Bone Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneus Fractures
Keywords
Calcaneus Fractures, Iliac Crest Bone Grafting, Open Reduction & Internal Fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORIF with Bone Grafting
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ORIF without Bone Grafting
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
ORIF of Calcaneus with bone grafting
Intervention Description
The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) and Tricortical Iliac Crest bone grafting
Intervention Type
Procedure
Intervention Name(s)
ORIF of Calcaneus without bone grafting
Intervention Description
The calcaneus fracture will be surgically repaired with open reduction and internal fixation (ORIF) (no bone grafting)
Primary Outcome Measure Information:
Title
Union and healing of Calcaneus Fracture
Time Frame
3 month to 12 month healing period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena L Stewart, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham, Orthopaedic Trauma
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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