Clinical Trial: Arthroscopic Assisted Open Reduction Internal Fixation Versus Open Reduction Internal Fixation in Ankle Fractures

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Spectrum Health Hospitals

Current Primary Outcome:

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Rates of Complications [ Time Frame: 1 year ]
  Compare rates of Complication between AORIF versus ORIF of ankle fractures.
• Pain Scores [ Time Frame: 1 year ]
  Compare Pain Scores between AORIF versus ORIF of ankle fractures.

Original Secondary Outcome: Same as current

Information By: Spectrum Health Hospitals

Dates:
Date Received: March 14, 2017
Date Started: May 1, 2017
Date Completion: May 1, 2019
Last Updated: May 23, 2017
Last Verified: May 2017