A Study to Compare Outcomes from Deltoid Ligament Repair versus Not, for Patients who have Supination External Rotation Ankle Fractures
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 16-003179
NCT ID: NCT02863042
Sponsor Protocol Number: 16-003179
About this study
The purpose of this study is to compare the stability outcomes from deltoid ligament repair versus without in patients having an open, internal fixation of a distal fibula (ankle) fracture.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- > 18 years old
- Had a 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 follow up
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Glenn Shi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available