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

• ClinicalTrials.gov Identifier: NCT04028414
• Recruitment Status: Recruiting
• First Posted: July 22, 2019
• Last Update Posted: October 12, 2021
• Sponsor: Major Extremity Trauma Research Consortium
• Information provided by (Responsible Party): Major Extremity Trauma Research Consortium

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rehabilitation	Other: Early Weight Bearing	Not Applicable

Detailed Description:

The purpose of this multi-center, randomized controlled trial (RCT) is to compare outcomes following early versus delayed weight bearing among individuals with a traumatic ankle fracture. This study will enroll patients ages 18 or older surgically treated for an ankle fracture or fracture dislocation (without syndesmosis) at participating civilian trauma centers and military treatment facilities. Eligible patients will be identified during hospitalization for definitive treatment and enrolled prior to discharge or at the first post op clinic visit. Patients that consent to participate will complete a baseline assessment at the first post op clinic visit and will be randomized to early versus delayed weight bearing. Both treatment groups will receive standardized exercises that can be done at home or with a therapist. Outcomes will be evaluated at 6 weeks, 3, 6 and 12 months following definitive fracture fixation. All 6 week, 3 and 6 month evaluations will take place in the surgeon's outpatient clinic and involve clinical and radiographic assessments of healing as well as functional outcome surveys. The 12 month evaluation will be conducted by phone except for individuals who were judged not to be healed (clinically or radiographically) at 6 months; these participants will be asked to return for their 12 month evaluation (to assess healing). Simultaneously, a pilot RCT will be conducted in patients 18 or older surgically treated with a unicondylar plateau fracture without joint impaction.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures
• Actual Study Start Date: January 1, 2020
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: September 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early Weight Bearing; 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; Patients will be instruction to weight bear as tolerated while in a boot.
No Intervention: Delayed Weight Bearing; 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Study Related Complications Experienced [ Time Frame: 12 months ]
   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.
2. Return to Usual Major Activity and Work Productivity [ Time Frame: 12 months ]
   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).

Secondary Outcome Measures :

1. Self-Reported Measures of Function [ Time Frame: 12 months ]
   Self-Reported Measures of Function will be assessed at 6 weeks and 3, 6 and 12 months post-injury using the Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Test (CAT) item banks, a product of the NIH Roadmap for Medical Research
2. Pain Score [ Time Frame: 12 months ]
   Pain will be measured using the Brief Pain Inventory (BPI) pain intensity domain at 3, 6 and 12 months. 27 The BPI pain intensity domain is compatible with the IMMPACT guidelines for assessing pain in clinical trials and the FDA Guidance for Industry on the use of Patient-Reported Outcome.
3. Pain Interference [ Time Frame: 12 months ]
   Pain will also be measured using the PROMIS Pain interference subscale. In addition, at each follow-up, the treating surgeon will also record the type and frequency of pain medications (grouped as acetaminophen, opioids, GABA analogues, NSAIDs and other).
4. Joint Range of Motion (ROM) [ Time Frame: 6 months ]
   Joint range of motion (ROM) will be assessed using a plastic goniometer, an inexpensive device with two plastic arms that are aligned with relevant body segments to quickly provide joint angle information.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Adults ages 18 or older

2. Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria:

   1. bimalleolar fracture requiring fixation of any two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
   2. bimalleolar equivalent SER4 fractures (lateral malleolus fracture requiring fixation and no medial or posterior malleolus fixation)
   3. trimalleolar fracture with fixation of at least two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
3. Operative treatment of an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.

Exclusion Criteria:

1. Gustilo Type III injuries or soft tissue injury of either lower extremity that would contra-indicate immediate or delayed WB
2. Syndesmotic injuries/fixation
3. 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)
4. Neuropathy, defined as diagnosis of peripheral neuropathy in medical record, neuropathic foot ulcer, or diminished or absent plantar sensation to light touch.
5. Pathologic fracture related to neoplasm
6. Fractures and dislocations to the ipsilateral or contralateral lower limb that prevent weight bearing as tolerated after fist post-op visit
7. 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)
8. Any upper limb injury that would limit upper extremity weight bearing (e.g., surgical neck fracture of proximal humerus)
9. 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)
10. Patient has third degree burns on >10% total surface area affecting the study limb
11. Tibial plateau fractures that are required to wear a locking brace or fractures that require fixed immobilization beyond four weeks (e.g., cast)
12. Non-ambulatory pre-injury
13. Pre-injury limitation to ROM of ipsilateral hip, knee or ankle
14. Morbidly obese (BMI ≥40)
15. Documented psychiatric disorder requiring admission in perioperative period
16. Severe problems with maintaining follow-up (e.g., patients who are prisoners or homeless at the time of injury or who are intellectually challenged without adequate family support)

Contacts and Locations

Contacts

Contact: ELIZABETH WYSOCKI, MS; 4109550396; ewysock2@jhu.edu

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator: Candice Dubose, MD

United States, California

University of California San Francisco Medical Center; Recruiting

San Francisco, California, United States, 94143

Principal Investigator: Theodore Miclau, MD

United States, Indiana

Methodist Hospital; Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator: Roman Natoli, MD

United States, Maryland

University of Maryland R Adams Cowley Shock Trauma Center; Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator: Robert O'Toole, MD

Walter Reed National Military Medical Center; Not yet recruiting

Bethesda, Maryland, United States, 20889

Principal Investigator: Benjamin Potter, MD

United States, Minnesota

Hennepin County Medical Center / Regions Hospita; Recruiting

Minneapolis, Minnesota, United States, 55415

Principal Investigator: Andrew Schmidt, MD

United States, New Hampshire

Dartmouth-Hitchcock Medical Center; Recruiting

Lebanon, New Hampshire, United States, 03756

Principal Investigator: Leah Gitajn, MD

United States, North Carolina

Carolinas Medical Center; Recruiting

Charlotte, North Carolina, United States, 28204

Principal Investigator: Madhav Karunakar, MD

Womack Army Medical Center at Ft. Bragg; Not yet recruiting

Fort Bragg, North Carolina, United States, 28100

Principal Investigator: Kenneth Nelson, MD

Wake Forest Baptist Medical Center; Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator: Jason Halvorson, MD

United States, Oklahoma

University of Oklahoma; Recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator: David Teague, MD

United States, Pennsylvania

Penn State Hershey Medical Center; Not yet recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator: J Spence Reid, MD

University of Pittsburgh Medical Center; Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Principal Investigator: Gele Maloney, MD

United States, Tennessee

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator: William T. Obremskey, MD, MPH

United States, Texas

University of Texas Health Science Center - Houston; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Joshua Gary, MD

San Antonio Military Medical Center (SAMMC); Recruiting

San Antonio, Texas, United States, 78234

Principal Investigator: Jason Alderete, MD

United States, Virginia

University of Virginia; Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator: David Weiss, MD

Inova Fairfax Hospital; Recruiting

Falls Church, Virginia, United States, 22042

Principal Investigator: Robert Hymes, MD

United States, Washington

University of Washington/Harborview Medical Center; Recruiting

Seattle, Washington, United States, 98104

Principal Investigator: Mike Githens, MD

United States, Wisconsin

University of Wisconsin; Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator: Paul Whiting, MD

Sponsors and Collaborators

Major Extremity Trauma Research Consortium

Investigators

• Principal Investigator: Lisa Reider, PhD; Major Extremity Trauma Research Consortium

More Information

• Responsible Party: Major Extremity Trauma Research Consortium
• ClinicalTrials.gov Identifier: NCT04028414
• Other Study ID Numbers: W81XWH-18-1-0810
• First Posted: July 22, 2019
• Last Update Posted: October 12, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

Data sharing beyond manuscripts and scientific presentations will be processed through the METRC website in the short term. Currently, a standard form will be available for researchers outside METRC to request access to final data generated from METRC studies. These requests will be transmitted to the METRC Coordinating Center for initial review to make sure the relevant materials are provided in support of the request. METRC is committed to making data as widely available as possible while safeguarding the privacy of study participants and protecting the intellectual property of the Consortium.

Data will only be made available after it is completely stripped of identifiable information such as dates, geographic locators, and any other event information which is sufficiently rare as to make it possible to deduce the identity of an individual participant. When necessary for complete de-identification, data may be grouped.

• Time Frame: Once study activities are complete.
• Access Criteria: See plan description.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No