Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures
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|ClinicalTrials.gov Identifier: NCT04028414|
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : October 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rehabilitation||Other: Early Weight Bearing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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).
- 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
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028414
|Contact: ELIZABETH WYSOCKI, MSfirstname.lastname@example.org|
|Principal Investigator:||Lisa Reider, PhD||Major Extremity Trauma Research Consortium|