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Search / Trial NCT05595148

Immediate Weightbearing vs Delayed Weightbearing

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Oct 25, 2022

Trial Information

Current as of June 27, 2025

Enrolling by invitation

Keywords

Feasibility Orthopaedic Trauma Randomized Care Wbat Delayed Weightbearing

ClinConnect Summary

Weight bearing restrictions are increasingly being scrutinized, as understanding of the potential negative effects of immobilization expand. Recent studies have highlighted that early WBAT may be safe following fixation of lower extremity, pelvis, and acetabulum fractures where the standard of care has been delayed WBAT, but high-quality prospective studies on this topic are needed.

The investigator hypothesizes that in a feasibility trial of immediate versus delayed WBAT following lower extremity, pelvis, and acetabulum fracture fixation, this trial will:

1. be able to enroll 50% of elig...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Fracture of the acetabulum, pelvis, distal femur, distal tibia, including those with intra- articular extension, that meets surgical indications.
  • Operative treatment within 7 days of injury at R Adams Cowley Shock Trauma Center, University of Maryland, University of Maryland Medical System, University of Maryland Capital Region Medical Center.
  • Provision of informed consent.
  • Exclusion Criteria:
  • Non English Speaking.
  • Cognitive ability does not allow for full understanding of study procedures ( Patient has been diagnosed with psychiatric condition, intellectually challenged without adequate family support).
  • Patient has other orthopaedic or non-orthopaedic injuries that would preclude him/her from being able to weight bear immediately (e.g. open fractures, polytrauma.
  • Significant impaction (\>2mm) or comminution at joint surface (e.g. with acetabulum, distal femur, tibial plateau, or tibial plafond fractures).
  • Patients who would not be able to immediately weight bear or comply with weight bearing restrictions.
  • Not willing to be randomized.
  • Surgeon or clinical follow will not occur at participating hospital or location.
  • Anticipated problems with follow up in the judgement of study personnel ( patient is homeless).

About University Of Maryland, Baltimore

The University of Maryland, Baltimore (UMB) is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMB leverages its extensive resources and expertise across various disciplines, including medicine, pharmacy, nursing, and social work, to contribute to groundbreaking discoveries and improve patient outcomes. Committed to ethical research practices and collaboration, UMB fosters an environment that promotes the translation of scientific knowledge into real-world applications, ultimately enhancing the well-being of diverse populations.

Locations

Baltimore, Maryland, United States

Cheverly, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Robert O'Toole, MD

Principal Investigator

University of Maryland, Baltimore

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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