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?

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).

Study Overview

• Status: Withdrawn
• Conditions: Ankle Fractures
• Intervention / Treatment: Procedure: Arthroscopic Assisted Open Reduction Internal Fixation; Procedure: Open Reduction Internal Fixation

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AORIF of Ankle Fractures; Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture.	Procedure: Arthroscopic Assisted Open Reduction Internal Fixation; Surgical fixation of ankle fractures with use of arthroscopy.; Other Names: AORIF
Active Comparator: ORIF of Ankle Fractures; Open Reduction Internal Fixation of ankle fracture.	Procedure: Open Reduction Internal Fixation; Surgical fixation of ankle fractures.; Other Names: ORIF

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Complications	Compare rates of Complication between AORIF versus ORIF of ankle fractures.	1 year
Pain Scores	Compare Pain Scores between AORIF versus ORIF of ankle fractures.	1 year

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Investigators: Principal Investigator: Kevin Anderson, MD, Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 2017-061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No