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

NCT ID: NCT03625154

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-12-30

Brief 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.

Conditions

Ankle Fractures

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

non operative control group

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

Group Type: ACTIVE_COMPARATOR

non operative management

Intervention Type: OTHER

closed reduction and splinting followed by progressive weight bearing

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.

Group Type: ACTIVE_COMPARATOR

non operative management

Intervention Type: OTHER

closed reduction and splinting followed by progressive weight bearing

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

Group Type: ACTIVE_COMPARATOR

ankle open reduction internal fixation

Intervention Type: PROCEDURE

Open Reduction and Internal Fixation with plates and screws

Interventions

ankle open reduction internal fixation

Open Reduction and Internal Fixation with plates and screws

Intervention Type: PROCEDURE

non operative management

closed reduction and splinting followed by progressive weight bearing

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Charles Moon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Pro47932

Identifier Type: -

Identifier Source: org_study_id