Study Stopped
PI pulled the study. No participants.
Is Deltoid Ligament Repair for Ankle Fracture Necessary?
AnkleFX
Is Deltoid Ligament Repair in Supination-external Rotation Ankle Fractures Necessary? A Prospective Cohort Study.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 19, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2018
CompletedAugust 22, 2018
August 1, 2018
2.3 years
May 19, 2016
August 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
baseline, 6 month post-operative visit
Secondary Outcomes (1)
Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale
2 year postoperative visit
Study Arms (2)
Deltoid Tendon Repaired
EXPERIMENTALRepair Deltoid Tendon
Ankle Fracture Without Deltoid Tendon Repair
OTHERInterventions
Standard of care
Eligibility Criteria
You may qualify if:
- Supination-external rotation ankle fracture with deltoid ligament incompetency
- Minimum of 2 year clinical follow up
You may not qualify if:
- Non-supination-external rotation ankle fracture
- Medial malleolus fracture
- Incomplete clinical or radiographic followup.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glenn G Shi
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopedic Consultant
Study Record Dates
First Submitted
May 19, 2016
First Posted
August 11, 2016
Study Start
May 1, 2016
Primary Completion
August 20, 2018
Study Completion
August 20, 2018
Last Updated
August 22, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share