Ankle Fracture vs Ankle Fracture-Dislocation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02198768|
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : January 31, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Functional Outcome After Ankle Fractures and Ankle Fracture-Dislocations: A Prospective Study|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||January 2017|
Patients with isolated ankle fractures.
Patients with ankle fracture-dislocations.
- Change in Functional Outcome [ Time Frame: 6, 12, and 24 months ]
Clinical and functional outcomes will be measured using the Foot and Ankle Ability Measure (FAAM) and the Short Form Musculoskeletal Functional Assessment (SMFA).
Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.
- Radiographic Outcome [ Time Frame: 24 month ]Radiographic analysis will be performed to determine nonunion, malunion, joint space incongruity, hardware failure/loosening, and/or severity of osteoarthritis. The Van Dijk grading scale will be used for radiographic assessment.
- Additional surgical procedures [ Time Frame: 2 years ]Documentation of any additional surgical procedures conducted on the affected ankle. Any surgical procedure will be noted. These may include debridement for infection or dehiscence, revision for hardware failure, arthroscopy, ankle arthrodesis, or cartilage restoration procedures.
- Postoperative Complications [ Time Frame: 2 years ]Postoperative complications will be documented and analyzed to determine if there are significant differences between the two groups. These will include infection requiring antibiotics or debridement, hardware failure, nerve or vascular injury, deep venous thrombosis, or revision surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198768
|United States, North Carolina|
|Carolinas Medical Center- Main|
|Charlotte, North Carolina, United States, 28204|
|Principal Investigator:||Michael Bosse, MD||Carolinas Healthcare System|