Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures

Ankle Fractures Clinical Trial

Official title:

Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03625154
• Other study ID #: Pro47932
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. All patients presenting will be treated non operatively, and compared to an observational group comprised of patients with Weber B lateral malleolus ankle fractures without medial clear space widening, for which the standard of care is non operative management.

Patients who decline non operative management and elect to undergo operative open reduction internal fixation with plates and screws will comprise an operative observational cohort.

All patients will be followed for a total of 12 months from the time of injury. Clinical outcomes will be based on radiographic monitoring for ankle mortise congruency, as well as standardized SF-36 and AOFAS questionnaire scores.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2020
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years old

• able to provide informed consent

Exclusion Criteria:

• pregnancy

• prisoners

• psychiatric conditions that prevent ability to provide informed consent or present barriers to follow up

• insulin dependent diabetics

• patients with prior musculoskeletal issues affecting the same extremity

• Patients cannot simultaneously be enrolled in any other studies.

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Procedure:
• ankle open reduction internal fixation
Open Reduction and Internal Fixation with plates and screws

Other:
• non operative management
closed reduction and splinting followed by progressive weight bearing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiographic outcome of ankle congruency	measurement of medial clear space between medial malleolus and medial talar dome, measurement of tibiofibular overlap 1cm superior to the plafond, and measurement of superior clear space between the tibial plafond and the talar dome	1 year
Secondary	functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system	total score 0-100, with 100 being the maximum best score. (pain (0-40 points), function (0-50 points) and alignment (0-10 points)	1 year
Secondary	additional functional outcome by Short Form Survey (SF-36) Score scoring system	0 to 100 range, 100 being the best; subscores Physical functioning (0-10), Role limitations due to physical health (0-4), Role limitations due to emotional problems (0-3), Energy/fatigue (0-4)Emotional well-being (0-5), Social functioning (0-2), Pain (0-2), General Health 0-5	1 year
Secondary	functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score	none, mild occasional, moderate daily, severe and almost always present	1 year
Secondary	functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements	no limitations and no support, no limitation of daily activities but limitation of recreational activities, limited daily and recreational activities, or severe limitation of daily and recreational activities	1 year
Secondary	functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment	good plantigrade, midfoot well aligned; fair plamtigrade, some degree of midfoot malalignment, poor with nonplantigrade foot, severe malalignment	1 year