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

Primary Purpose

Ankle Fractures

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arthroscopic Assisted Open Reduction Internal Fixation
Open Reduction Internal Fixation
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spectrum Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AORIF of Ankle Fractures

ORIF of Ankle Fractures

Arm Description

Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture.

Open Reduction Internal Fixation of ankle fracture.

Outcomes

Primary Outcome Measures

American Orthopedic Foot and Ankle Score (AOFAS)
Compare AOFAS scores between AORIF versus ORIF of ankle fractures.
Foot and Ankle Ability Measure (FAAM)
Compare FAAM scores between AORIF versus ORIF of ankle fractures.
Rate of Return to Sports
Compare Return to Sports rates between AORIF versus ORIF of ankle fractures.

Secondary Outcome Measures

Rates of Complications
Compare rates of Complication between AORIF versus ORIF of ankle fractures.
Pain Scores
Compare Pain Scores between AORIF versus ORIF of ankle fractures.

Full Information

First Posted
March 14, 2017
Last Updated
May 23, 2017
Sponsor
Spectrum Health Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03084263
Brief Title
Arthroscopic Assisted Open Reduction Internal Fixation Versus Open Reduction Internal Fixation in Ankle Fractures
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?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn (No Participants Enrolled)
Study Start Date
May 1, 2017 (Anticipated)
Primary Completion Date
May 1, 2018 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AORIF of Ankle Fractures
Arm Type
Experimental
Arm Description
Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture.
Arm Title
ORIF of Ankle Fractures
Arm Type
Active Comparator
Arm Description
Open Reduction Internal Fixation of ankle fracture.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Assisted Open Reduction Internal Fixation
Other Intervention Name(s)
AORIF
Intervention Description
Surgical fixation of ankle fractures with use of arthroscopy.
Intervention Type
Procedure
Intervention Name(s)
Open Reduction Internal Fixation
Other Intervention Name(s)
ORIF
Intervention Description
Surgical fixation of ankle fractures.
Primary Outcome Measure Information:
Title
American Orthopedic Foot and Ankle Score (AOFAS)
Description
Compare AOFAS scores between AORIF versus ORIF of ankle fractures.
Time Frame
6 month
Title
Foot and Ankle Ability Measure (FAAM)
Description
Compare FAAM scores between AORIF versus ORIF of ankle fractures.
Time Frame
1 year
Title
Rate of Return to Sports
Description
Compare Return to Sports rates between AORIF versus ORIF of ankle fractures.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rates of Complications
Description
Compare rates of Complication between AORIF versus ORIF of ankle fractures.
Time Frame
1 year
Title
Pain Scores
Description
Compare Pain Scores between AORIF versus ORIF of ankle fractures.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Anderson, MD
Organizational Affiliation
Spectrum Health Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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