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

Cedars-Sinai Medical Center

Status: Unknown

Conditions: Ankle Fractures

Treatments: Procedure: ankle open reduction internal fixation; Other: non operative management

Study type: Interventional

Funder types: Other

Identifiers

NCT03625154

Pro47932

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

non operative control group

Active Comparator group

Description:

Patients with negative gravity stress (non-operative treatment/observational control group)

Treatment:

Other: non operative management

non operative experimental group

Active Comparator group

Description:

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.

Treatment:

Other: non operative management

operative observational group

Active Comparator group

Description:

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

Treatment:

Procedure: ankle open reduction internal fixation