Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures
Primary Purpose
Intra-articular Fractures
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sinus Tarsi approach
Extensile Lateral approach
Sponsored by
About this trial
This is an interventional treatment trial for Intra-articular Fractures focused on measuring calcaneus, fracture fixation, internal
Eligibility Criteria
Inclusion Criteria:
- Skeletally mature patients ≥ 18 years of age
- Closed intra-articular calcaneus fractures
- Undergoing surgical fixation (CPT code 28415)
- Ability to understand and agree to informed consent
Exclusion Criteria:
- Patients < 18 years of age
- Open fractures
- Dislocations that require open reduction
- Previous calcaneus abnormality or injury
- Unable to understand or agree to informed consent
Sites / Locations
- Erlanger Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sinus Tarsi approach
Extensile Lateral approach
Arm Description
The Sinus Tarsi approach is the surgical approach for the incision.
The Extensile Lateral approach is the surgical approach for the incision.
Outcomes
Primary Outcome Measures
Wound complication rate
There is an expected wound complication rate of up to 30% with this type of fracture. The difference in wound complication rate between the two surgical approaches will be the primary outcome measure. Wound complications will be defined by the presence of superficial or deep infections, skin edge necrosis, and soft tissue sloughing.
Secondary Outcome Measures
Fracture healing
On radiographic and clinical exam
Rate of sural nerve injury
Rate of peroneal tendon injury
Change in operative time
Rate of secondary surgery
Visual Analog Scale
Pain Score
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
Functional Outcome Score
Foot Function Index
Functional Outcome Score
Short-Form 36 (SF-36) Health Survey
Functional Outcome Score
Full Information
NCT ID
NCT02446470
First Posted
April 30, 2015
Last Updated
November 27, 2018
Sponsor
University of Tennessee
1. Study Identification
Unique Protocol Identification Number
NCT02446470
Brief Title
Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures
Official Title
Sinus Tarsi Versus Extensile Lateral Approach for Open Reduction Internal Fixation of Intra-articular Calcaneus Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures.
It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-articular Fractures
Keywords
calcaneus, fracture fixation, internal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sinus Tarsi approach
Arm Type
Experimental
Arm Description
The Sinus Tarsi approach is the surgical approach for the incision.
Arm Title
Extensile Lateral approach
Arm Type
Active Comparator
Arm Description
The Extensile Lateral approach is the surgical approach for the incision.
Intervention Type
Procedure
Intervention Name(s)
Sinus Tarsi approach
Intervention Description
A straight incision is made on the lateral side of the foot from the tip of the fibula to the base of the fourth metatarsal which centers the incision over the sinus tarsi. Then careful dissection is made through the subcutaneous tissues to prevent damage to the sural nerve, peroneal tendons, and extensor digitorum brevis (EDB). The origin of EDB is identified and the muscle is released distal enough to fully visualize the fracture and articular surface of the calcaneus. Following exposure of the fracture and articular surface of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern.
Intervention Type
Procedure
Intervention Name(s)
Extensile Lateral approach
Intervention Description
An L-shaped incision overlying the lateral wall of the calcaneus will be made, followed by sharp dissection of soft tissues in line with the skin incision down to the periosteum. Effort will be made to identify and protect the sural nerve, as it commonly crosses the surgical field with this approach. The soft tissue flap is retracted as a single unit as subperiosteal dissection is performed. Following exposure of the lateral wall of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern.
Primary Outcome Measure Information:
Title
Wound complication rate
Description
There is an expected wound complication rate of up to 30% with this type of fracture. The difference in wound complication rate between the two surgical approaches will be the primary outcome measure. Wound complications will be defined by the presence of superficial or deep infections, skin edge necrosis, and soft tissue sloughing.
Time Frame
approximately one year
Secondary Outcome Measure Information:
Title
Fracture healing
Description
On radiographic and clinical exam
Time Frame
approximately one year
Title
Rate of sural nerve injury
Time Frame
approximately one year
Title
Rate of peroneal tendon injury
Time Frame
approximately one year
Title
Change in operative time
Time Frame
one day
Title
Rate of secondary surgery
Time Frame
approximately one year
Title
Visual Analog Scale
Description
Pain Score
Time Frame
approximately one year
Title
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
Description
Functional Outcome Score
Time Frame
approximately one year
Title
Foot Function Index
Description
Functional Outcome Score
Time Frame
approximately one year
Title
Short-Form 36 (SF-36) Health Survey
Description
Functional Outcome Score
Time Frame
approximately one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Skeletally mature patients ≥ 18 years of age
Closed intra-articular calcaneus fractures
Undergoing surgical fixation (CPT code 28415)
Ability to understand and agree to informed consent
Exclusion Criteria:
Patients < 18 years of age
Open fractures
Dislocations that require open reduction
Previous calcaneus abnormality or injury
Unable to understand or agree to informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse F Doty, MD
Organizational Affiliation
University of Tennessee College of Medicine Chattanooga/Erlanger Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures
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