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

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.

Study Overview

• Status: Unknown
• Conditions: Ankle Fractures
• Intervention / Treatment: Other: non operative management; Procedure: ankle open reduction internal fixation

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: non operative control group; Patients with negative gravity stress (non-operative treatment/observational control group)	Other: non operative management; closed reduction and splinting followed by progressive weight bearing
Active Comparator: non operative experimental group; Patients with positive gravity stress (medial clear space > 4 mm on initial injury pre-reduction x-rays, who undergo a reduction with closing of the medial clear space to <4mm. Plan for nonoperative treatment of all these patients with splint and subsequent walker boot.	Other: non operative management; closed reduction and splinting followed by progressive weight bearing
Active Comparator: operative observational group; Patients with positive gravity stress (medial clear space > 4 mm) who undergo a reduction with closing of the medial clear space to <4mm who declined non-operative treatment but agree to be observed. These patients will undergo ORIF (Open Reduction and Internal Fixation) with plates and screws and function as a second observation group	Procedure: ankle open reduction internal fixation; Open Reduction and Internal Fixation with plates and screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score	none, mild occasional, moderate daily, severe and almost always present	1 year
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
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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): July 18, 2019
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: Pro47932

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No