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

Ankle Fractures Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03084263
• Other study ID #: 2017-061
• Status: Withdrawn
• Phase: N/A
• First received: March 14, 2017
• Last updated: May 23, 2017
• Start date: May 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2017
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Procedure:
• Arthroscopic Assisted Open Reduction Internal Fixation
Surgical fixation of ankle fractures with use of arthroscopy.
• Open Reduction Internal Fixation
Surgical fixation of ankle fractures.

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopedic Foot and Ankle Score (AOFAS)	Compare AOFAS scores between AORIF versus ORIF of ankle fractures.	6 month
Primary	Foot and Ankle Ability Measure (FAAM)	Compare FAAM scores between AORIF versus ORIF of ankle fractures.	1 year
Primary	Rate of Return to Sports	Compare Return to Sports rates between AORIF versus ORIF of ankle fractures.	1 year
Secondary	Rates of Complications	Compare rates of Complication between AORIF versus ORIF of ankle fractures.	1 year
Secondary	Pain Scores	Compare Pain Scores between AORIF versus ORIF of ankle fractures.	1 year