NCT03084263

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

March 14, 2017

Last Update Submit

May 23, 2017

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Rates of Complications

    1 year

  • Pain Scores

    1 year

Study Arms (2)

AORIF of Ankle Fractures

EXPERIMENTAL

Arthroscopic Assisted Open Reduction Internal Fixation of ankle fracture.

Procedure: Arthroscopic Assisted Open Reduction Internal Fixation

ORIF of Ankle Fractures

ACTIVE COMPARATOR

Open Reduction Internal Fixation of ankle fracture.

Procedure: Open Reduction Internal Fixation

Interventions

Arthroscopic Assisted Open Reduction Internal FixationPROCEDURE

Surgical fixation of ankle fractures with use of arthroscopy.

Also known as: AORIF
AORIF of Ankle Fractures
Open Reduction Internal FixationPROCEDURE

Surgical fixation of ankle fractures.

Also known as: ORIF
ORIF of Ankle Fractures

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Closed ankle fractures (44A, 44B, 44C)
  • Ages of 18-65
  • Men or women, including pregnant women
  • Willing to consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Kevin Anderson, MD

    Corewell Health West

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 20, 2017

Study Start

May 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2019

Last Updated

May 25, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)