Intra-articular Fractures
Conditions
Keywords
calcaneus, fracture fixation, internal
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.
Interventions
PROCEDURESinus Tarsi approach
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.
PROCEDUREExtensile Lateral approach
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.
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound complication rate | approximately one year | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in operative time | one day | — |
| Rate of secondary surgery | approximately one year | — |
| Visual Analog Scale | approximately one year | Pain Score |
| Fracture healing | approximately one year | On radiographic and clinical exam |
| Rate of peroneal tendon injury | approximately one year | — |
| American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale | approximately one year | Functional Outcome Score |
| Foot Function Index | approximately one year | Functional Outcome Score |
| Short-Form 36 (SF-36) Health Survey | approximately one year | Functional Outcome Score |
| Rate of sural nerve injury | approximately one year | — |
Countries
United States
Outcome results
None listed