Expired Study
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Orlando, Florida 32806


Purpose:

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.


Study 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. 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.


Criteria:

Inclusion Criteria: - Distal fibula fracture - Pilon fractures - Open fractures - Ipsilateral foot Exclusion Criteria: - Weber A distal fibula fractures - Pathologic fractures


Study is Available At:


Original ID:

15.037.04.


NCT ID:

NCT02507193


Secondary ID:


Study Acronym:


Brief Title:

Fibular Fixation in Ankle Fractures:Plate Verses Nail.


Official Title:

Fibular Fixation in Ankle Fractures: a Randomized-Controlled Trial Comparing Plating Versus Intramedullary Nailing


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Orlando Health, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

51


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kenneth J. Koval, MD
Study Director
Orlando Health

Study Dates

Start Date:July 2015
Completion Date:August 15, 2019
Completion Type:Actual
Primary Completion Date:August 15, 2019
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:August 27, 2019
First Received Date:June 3, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Functional outcome using the Olerud-Molander score.
Time Frame:One year.
Safety Issues:False
Description:The Olerud-Molander score is as assessment of symptoms after ankle fracture.

Study Interventions

Intervention Type:Procedure
Name:Open reduction internal fixation
Description: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.
Arm Name:Open reduction internal fixation(ORIF)
Other Name:ORIF
Intervention Type:Procedure
Name:Intermedullary Nail
Description: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.
Arm Name:Intermedullary (IM) Nail

Study Arms

Study Arm Type:Active Comparator
Arm Name:Open reduction internal fixation(ORIF)
Description:This surgical intervention is performed using a plate and screws.Under general anesthesia, 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.
Study Arm Type:Active Comparator
Arm Name:Intermedullary (IM) Nail
Description:This surgical intervention is performed using an intermedullary nail. Under general anesthesia, 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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Orlando Health, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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