NCT03084263

Arthroscopic Assisted Open Reduction Internal Fixation Versus Open Reduction Internal Fixation in Ankle Fractures

A Comparison Study of Arthroscopic Assisted Open Reduction Internal Fixation (AORIF) Versus Open Reduction Internal Fixation (ORIF) in Ankle Fractures: Does AORIF Improve Functional Outcomes?

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Corewell Health West · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the functional outcomes of patients with ankle fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus Open Reduction Internal Fixation (ORIF).

Detailed description

Prospective Randomized Clinical Trial evaluating patients with ankle fractures undergoing AORIF versus ORIF Participants will be randomized into 2 different surgical groups, one group receiving only ORIF and the other group receiving AORIF. As standard of care patients will follow up in the office at approximately 3 weeks, 6 weeks and 12 weeks post operatively. Patients will be immobilized in a splint and will be non-weight bearing until their 3 week post-op visit. At the 3 week post-op visit, the patient will be fitted in a boot, be instructed to begin self-directed ROM and to continue non-weight bearing. At the 6 week post-op visit, the patient will begin weight bearing in the boot. In office study visit will occur at these same times. At each visit weight bearing status, return to sports, pain level, AOFAS and FAAM will be assessed. One additional study visit will be conducted over the phone or by mail at approximately one year post operatively and will consist of the FAAM.

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic Assisted Open Reduction Internal Fixation	Surgical fixation of ankle fractures with use of arthroscopy.
PROCEDURE	Open Reduction Internal Fixation	Surgical fixation of ankle fractures.

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-05-01
• Completion: 2019-05-01
• First posted: 2017-03-20
• Last updated: 2017-05-25

Locations

1 site across 1 country: United States