- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04028414
Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
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California
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San Francisco, California, United States, 94143
- Recruiting
- University of California San Francisco Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46202
- Recruiting
- Methodist Hospital
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Maryland
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Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland R Adams Cowley Shock Trauma Center
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Bethesda, Maryland, United States, 20889
- Not yet recruiting
- Walter Reed National Military Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- Recruiting
- Hennepin County Medical Center / Regions Hospita
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Recruiting
- Dartmouth-Hitchcock Medical Center
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Recruiting
- Carolinas Medical Center
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Fort Bragg, North Carolina, United States, 28100
- Not yet recruiting
- Womack Army Medical Center at Ft. Bragg
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest Baptist Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Not yet recruiting
- Penn State Hershey Medical Center
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Pittsburgh, Pennsylvania, United States, 15219
- Recruiting
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University Medical Center
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- University of Texas Health Science Center - Houston
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San Antonio, Texas, United States, 78234
- Recruiting
- San Antonio Military Medical Center (SAMMC)
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Virginia
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Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia
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Falls Church, Virginia, United States, 22042
- Recruiting
- Inova Fairfax Hospital
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Washington
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Seattle, Washington, United States, 98104
- Recruiting
- University of Washington/Harborview Medical Center
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Wisconsin
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Madison, Wisconsin, United States, 53705
- Recruiting
- University of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Patients will be instruction to weight bear as tolerated while in a boot.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Study Related Complications Experienced
Time Frame: 12 months
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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.
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12 months
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Return to Usual Major Activity and Work Productivity
Time Frame: 12 months
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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).
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Reported Measures of Function
Time Frame: 12 months
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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
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12 months
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Pain Score
Time Frame: 12 months
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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.
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12 months
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Pain Interference
Time Frame: 12 months
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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).
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12 months
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Joint Range of Motion (ROM)
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- W81XWH-18-1-0810
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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