Trials / Completed
CompletedNCT02507193
Fibular Fixation in Ankle Fractures:Plate Verses Nail.
Fibular Fixation in Ankle Fractures: a Randomized-Controlled Trial Comparing Plating Versus Intramedullary Nailing
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Orlando Health, Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (IMN) fixation or plate fixation.
Detailed description
The primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (IMN) fixation or plate fixation. This objective will be accomplished using the Olerud-Molander score, a commonly accepted functional outcome score used to evaluate patients post-operatively who have undergone foot and ankle procedures. It is a survey that evaluates patient reported outcomes including pain, stiffness, swelling, stair climbing, running, jumping, squatting, use of supports, and work/activities of daily living (ADL) level. It does not involve physician-measured outcomes. The best possible score is a total of 100. Patients will be given a form to complete throughout follow-up and be utilized for data analysis. Functional outcome will be analyzed with regards to type of fracture, gender, cause of fracture, and affected side to determine if these factors are responsible for any difference.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Open reduction internal fixation | An incision is made at the site of the break or injury, and the fracture is carefully re-aligned . The plate and screws are installed, and the incision is closed with staples or stitches. Synthes and Stryker plate and screws will be used. |
| PROCEDURE | Intermedullary Nail | An incision is made at the site of the break or injury, and the fracture is carefully reduced. The nail in inserted through the medullary canal after proper imaging for accurate placement. The incision is closed with staples or stitches. Acumed fibula nail will be used. |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2019-08-15
- Completion
- 2019-08-15
- First posted
- 2015-07-23
- Last updated
- 2019-08-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02507193. Inclusion in this directory is not an endorsement.