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

NCT03625154 | Unknown

• 1 other identifier: Pro47932
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system

  1 year

• additional functional outcome by Short Form Survey (SF-36) Score scoring system

  1 year

• functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score

  1 year

• functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements

  1 year

• functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment

  1 year

Study Arms (3)

non operative control group

ACTIVE COMPARATOR

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

Other: non operative management

non operative experimental group

ACTIVE COMPARATOR

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

operative observational group

ACTIVE COMPARATOR

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

Interventions

ankle open reduction internal fixation PROCEDURE

Open Reduction and Internal Fixation with plates and screws

operative observational group

non operative management OTHER

closed reduction and splinting followed by progressive weight bearing

non operative control group; non operative experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• able to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 10, 2018
• Study Start: September 1, 2018
• Primary Completion: July 18, 2019
• Study Completion: December 30, 2020
• Last Updated: August 10, 2018

Record last verified: 2018-08