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

Not Applicable

Withdrawn

• Conditions: Ankle Fractures
• Interventions: Procedure: Arthroscopic Assisted Open Reduction Internal Fixation; Procedure: Open Reduction Internal Fixation

• Registration Number: NCT03084263
• Lead Sponsor: Spectrum Health Hospitals

Brief 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.

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-20
• Status Verified: 2017-05
• Study Start: 2017-05-01
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-25
• Primary Completion: 2018-05-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Closed ankle fractures (44A, 44B, 44C)
• Ages of 18-65
• Men or women, including pregnant women
• Willing to consent

Exclusion Criteria

• Open fractures
• Other lower extremity injuries/conditions that affects functional outcomes
• Problems maintaining follow up (homeless, not willing to return for follow up)
• Prisoners
• Unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AORIF of Ankle Fractures	Arthroscopic Assisted Open Reduction Internal Fixation	Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture.
ORIF of Ankle Fractures	Open Reduction Internal Fixation	Open Reduction Internal Fixation of ankle fracture.

Primary Outcome Measures

Name	Time	Method
Rate of Return to Sports	1 year	Compare Return to Sports rates between AORIF versus ORIF of ankle fractures.
Foot and Ankle Ability Measure (FAAM)	1 year	Compare FAAM scores between AORIF versus ORIF of ankle fractures.
American Orthopedic Foot and Ankle Score (AOFAS)	6 month	Compare AOFAS scores between AORIF versus ORIF of ankle fractures.

Secondary Outcome Measures

Name	Time	Method
Rates of Complications	1 year	Compare rates of Complication between AORIF versus ORIF of ankle fractures.
Pain Scores	1 year	Compare Pain Scores between AORIF versus ORIF of ankle fractures.

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States