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Clinical Trials/NCT03084263
NCT03084263
Withdrawn
Not Applicable

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?

Spectrum Health Hospitals1 site in 1 countryMay 1, 2017
ConditionsAnkle Fractures

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankle Fractures
Sponsor
Spectrum Health Hospitals
Locations
1
Primary Endpoint
Rate of Return to Sports
Status
Withdrawn
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2017
End Date
May 1, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of Return to Sports

Time Frame: 1 year

Compare Return to Sports rates 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.

American Orthopedic Foot and Ankle Score (AOFAS)

Time Frame: 6 month

Compare AOFAS scores between AORIF versus ORIF of ankle fractures.

Secondary Outcomes

  • Rates of Complications(1 year)
  • Pain Scores(1 year)

Study Sites (1)

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