Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures

NCT04028414 | Active Not Recruiting DMC

• 1 other identifier: W81XWH-18-1-0810
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 17

Brief Summary

The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study.

Conditions

Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Number of Study Related Complications Experienced

  Re-admissions for a limb related issue and all re-operations on the study limb will be prospectively tracked by the Research Coordinators by routinely scanning hospital admission and orthopaedic surgery logs to identify all admissions and same day surgeries of patients actively enrolled in the study. Complications include loss of reduction and hardware failure, infection, non-union, malunion and fusion.

  12 months

• Return to Usual Major Activity and Work Productivity

  Participants will be asked what they were doing most of the time during the previous two weeks (working/active duty, laid off/looking for work, going to school, taking care of a home, etc.). If participants are working, the Work Productivity and Activity Impairment (WPAI) questionnaire will be administered.The WPAI measures work time missed and work and activity impairment because of a specified health problem during the past 7 days (http://www.reillyassociates.net/WPAI\_SHP.html).

  12 months

Study Arms (2)

Early Weight Bearing

EXPERIMENTAL

Patients with ankle fractures will be instructed to weight bear as tolerated (WBAT) while in a boot with a heel to toe normal gait and wean from walker or crutches to a cane or no support device. At the 6 week post op visit, patients with ankle fractures will be instructed to wean from the boot and continue full weight bearing as tolerated until full weight bearing is achieved. Patients with plateau fractures will be instructed to begin WBAT until full weight bearing is achieved.

Other: Early Weight Bearing

Delayed Weight Bearing

NO INTERVENTION

Patients with ankle fractures will be instructed to touch-down (toe touch or foot flat) weight bear (approximately 10% of body weight) while in the boot for. Patients will be instructed to keep foot off of floor or set ball of foot or heal on ground for balance using walker or crutches at all times. After the 6 week post op visit, patients may begin weight bearing as tolerated. Patients with tibial plateau fractures will be instructed to touch down (toe touch or foot flat) weight bear (approximately 10% of body weight) for at least 6 weeks. After the 6 week post op visit, patients may begin weight bearing as tolerated until full weight bearing is achieved.

Interventions

Early Weight Bearing OTHER

Patients will be instruction to weight bear as tolerated while in a boot.

Early Weight Bearing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18 or older
• Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria:
• bimalleolar fracture requiring fixation of any two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
• bimalleolar equivalent SER4 fractures (lateral malleolus fracture requiring fixation and no medial or posterior malleolus fixation)
• trimalleolar fracture with fixation of at least two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
• Operative treatment of an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.

You may not qualify if:

• Gustilo Type III injuries or soft tissue injury of either lower extremity that would contra-indicate immediate or delayed WB
• Syndesmotic injuries/fixation
• Osteoporosis as defined by treatment with a bisphosphonate and/or other osteoporosis medications, including Prolia and Forteo; or a prior fragility fracture (e.g., spine compression, proximal humerus, distal radius, femoral neck/intertrochanteric fracture)
• Neuropathy, defined as diagnosis of peripheral neuropathy in medical record, neuropathic foot ulcer, or diminished or absent plantar sensation to light touch.
• Pathologic fracture related to neoplasm
• Fractures and dislocations to the ipsilateral or contralateral lower limb that prevent weight bearing as tolerated after fist post-op visit
• Other contra-indication to immediate or delayed weight bearing (e.g., ipsilateral fracture effecting weight bearing status such as a calcaneus fracture); fractures of the ipsilateral lower extremity that would not affect WB status may be included (e.g., proximal femur, femoral shaft or tibia shaft fractures)
• Any upper limb injury that would limit upper extremity weight bearing (e.g., surgical neck fracture of proximal humerus)
• Injuries to other body systems that would affect the ability to comply with either WB protocol (e.g., spinal cord injury; severe TBI; major abdominal or chest injury)
• Patient has third degree burns on \>10% total surface area affecting the study limb
• Tibial plateau fractures that are required to wear a locking brace or fractures that require fixed immobilization beyond four weeks (e.g., cast)
• Non-ambulatory pre-injury
• Pre-injury limitation to ROM of ipsilateral hip, knee or ankle
• Morbidly obese (BMI ≥40)
• Documented psychiatric disorder requiring admission in perioperative period

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Hennepin County Medical Center / Regions Hospita

Minneapolis, Minnesota, 55415, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

San Antonio Military Medical Center (SAMMC)

San Antonio, Texas, 78234, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

University of Washington/Harborview Medical Center

Seattle, Washington, 98104, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Study Officials

• Lisa Reider, PhD

  Major Extremity Trauma Research Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 22, 2019
• Study Start: January 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Once study activities are complete.
• Access Criteria: See plan description.

Locations

US (17)