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Immediate vs Delayed Weightbearing for Broken Bones
N/A
Waitlist Available
Led By Robert O'Toole, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following definitive fixation surgery
Awards & highlights
Study Summary
This trial will study if immediate or delayed weight bearing is best for broken bones in lower extremities, pelvis, & acetabulum. 50 patients will be enrolled to compare reoperation & hardware failure.
Who is the study for?
This trial is for patients who've had surgery at specific Maryland medical centers within 7 days of a lower extremity, pelvis, or acetabulum fracture. They must understand the study and consent to participate. Excluded are non-English speakers, those with cognitive impairments without support, inability to weight bear immediately, unwillingness to be randomized or follow up issues.Check my eligibility
What is being tested?
The study tests immediate versus delayed weight bearing after fixing fractures in the lower body. Patients will either start putting weight on their leg right away (WBAT) or wait for 6-12 weeks. The goal is to see if this approach is feasible before launching a larger trial.See study design
What are the potential side effects?
Potential side effects aren't specified but may include complications from early weight bearing like increased pain, swelling, re-injury or hardware problems versus delayed healing and stiffness from waiting.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months following definitive fixation surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following definitive fixation surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Repeat Surgery
Secondary outcome measures
Percentage of patients who maintained follow-up
Trial Design
2Treatment groups
Active Control
Group I: Immediate WBATActive Control1 Intervention
Recent studies have highlighted that early WBAT is 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.
Group II: Delayed WBATActive Control1 Intervention
Though immediate postoperative WBAT has become the standard of care following fixation of pertrochanteric, femoral shaft, and tibial shaft fractures, most surgeons restrict patient weight bearing following fixation of other lower extremity and pelvis/acetabulum fractures. Progression to full weight bearing varies greatly by type of fracture, fixation method, and surgeon. Weight bearing restrictions following fracture fixation have been shown to be associated with various poor outcomes (increased complications, prolonged hospital length of stay, etc.), particularly in geriatric patients. Thus, it is important for us to understand if it is safe to allow early weight bearing following lower extremity and pelvis/acetabulum fracture fixation, as this could help expedite patient mobility and return to function, and potentially reduce complications.
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,546 Total Patients Enrolled
1 Trials studying Rehabilitation
33 Patients Enrolled for Rehabilitation
Robert O'Toole, MDPrincipal InvestigatorUniversity of Maryland Shock Trauma Center
4 Previous Clinical Trials
14,342 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not open to being assigned to a treatment by chance.I understand the study and what will be required of me.My bone fracture involves a joint surface being crushed or broken into pieces.I cannot put weight on my legs due to other injuries.I cannot put weight on my feet or follow weight-bearing restrictions right away.I have a break in my hip, pelvis, or lower leg bone that needs surgery.I had surgery within a week of my injury at a specified Maryland medical center.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate WBAT
- Group 2: Delayed WBAT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts still underway for this medical experiment?
"According to the latest information uploaded on clinicaltrials.gov, this medical trial has concluded its patient recruitment process. The original post date was April 1st 2023 and it was last updated 6 days later. Despite this study's completion of enrolment, there are still 69 other trials actively looking for participants at present."
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