Trials / Unknown
UnknownNCT02446470
Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures
Sinus Tarsi Versus Extensile Lateral Approach for Open Reduction Internal Fixation of Intra-articular Calcaneus Fractures
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- University of Tennessee · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Sinus 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. |
| PROCEDURE | Extensile 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. |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2015-05-18
- Last updated
- 2018-11-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02446470. Inclusion in this directory is not an endorsement.