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Is Deltoid Ligament Repair for Ankle Fracture Necessary? (AnkleFX)

Primary Purpose

Ankle Fracture

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repair Deltoid Tendon
Ankle Fracture Without Deltoid Tendon Repair
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Supination-external rotation ankle fracture with deltoid ligament incompetency
  • Minimum of 2 year clinical follow up

Exclusion criteria:

  • Non-supination-external rotation ankle fracture
  • Medial malleolus fracture
  • Incomplete clinical or radiographic followup.

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Deltoid Tendon Repaired

Ankle Fracture Without Deltoid Tendon Repair

Arm Description

Repair Deltoid Tendon

Outcomes

Primary Outcome Measures

Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA)
The 46-item SMFA questionnaire comprises two parts: the dysfunction index with 34 items and the bother index with 12 items. Each item has a 5-point response format (1 point for good function or not bothered and 5 points for poor function or extremely bothered). The scores of the dysfunction and the bother indices are calculated by summing up the responses to the items and then transforming the scores according to the formula: (actual raw score - lowest possible raw score)/(possible range of raw score) × 100. This transformation formula gives the final scores, which ranged from 0 to 100. The higher scores indicate poorer function.

Secondary Outcome Measures

Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale
The AOFAS Hindfoot Scale is an outcome rating system for ankle replacements. It is composed of the parameters pain (max 40 points), function (max 50 points) and alignment (max 10 points). Scores can range from 0 (severe pain, severely impaired function, and poor alignment) to 100 (no pain, no limitations on function, good alignment.)

Full Information

First Posted
May 19, 2016
Last Updated
August 20, 2018
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02863042
Brief Title
Is Deltoid Ligament Repair for Ankle Fracture Necessary?
Acronym
AnkleFX
Official Title
Is Deltoid Ligament Repair in Supination-external Rotation Ankle Fractures Necessary? A Prospective Cohort Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI pulled the study. No participants.
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.
Detailed Description
The purpose of this study is to evaluate whether stabilization with anatomic ankle deltoid ligament repair can help restore ankle congruity and improve functional outcome in patients with unstable supination-external rotation ankle fractures.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Deltoid Tendon Repaired
Arm Type
Experimental
Arm Description
Repair Deltoid Tendon
Arm Title
Ankle Fracture Without Deltoid Tendon Repair
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Repair Deltoid Tendon
Intervention Type
Other
Intervention Name(s)
Ankle Fracture Without Deltoid Tendon Repair
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA)
Description
The 46-item SMFA questionnaire comprises two parts: the dysfunction index with 34 items and the bother index with 12 items. Each item has a 5-point response format (1 point for good function or not bothered and 5 points for poor function or extremely bothered). The scores of the dysfunction and the bother indices are calculated by summing up the responses to the items and then transforming the scores according to the formula: (actual raw score - lowest possible raw score)/(possible range of raw score) × 100. This transformation formula gives the final scores, which ranged from 0 to 100. The higher scores indicate poorer function.
Time Frame
baseline, 6 month post-operative visit
Secondary Outcome Measure Information:
Title
Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale
Description
The AOFAS Hindfoot Scale is an outcome rating system for ankle replacements. It is composed of the parameters pain (max 40 points), function (max 50 points) and alignment (max 10 points). Scores can range from 0 (severe pain, severely impaired function, and poor alignment) to 100 (no pain, no limitations on function, good alignment.)
Time Frame
2 year postoperative visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Supination-external rotation ankle fracture with deltoid ligament incompetency Minimum of 2 year clinical follow up Exclusion criteria: Non-supination-external rotation ankle fracture Medial malleolus fracture Incomplete clinical or radiographic followup.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn G Shi
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Is Deltoid Ligament Repair for Ankle Fracture Necessary?

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