Immediate vs Delayed Weightbearing for Broken Bones

Recruiting at 1 trial location

Overseen By Casey Loudermilk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Non English speaking, Cognitive impairment, Polytrauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if patients with certain bone fractures can start using their injured leg or hip sooner than usual. It looks at immediate weight bearing versus waiting for a few weeks. The goal is to see if early use helps in healing without causing more problems.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is immediate weight-bearing safe for broken bones?

Research shows that immediate weight-bearing as tolerated (WBAT) is generally safe for certain types of fractures, like ankle and femur fractures, without increasing the risk of complications or implant failure. However, for some fracture types, like those around joints, more caution is advised, and further studies are needed to confirm safety. ^{1 2 3 4 5}

How does Immediate WBAT treatment differ from other treatments for broken bones?

Immediate WBAT (weight-bearing as tolerated) allows patients to start putting weight on their broken bones right after surgery, unlike traditional methods that often require waiting several weeks. This approach can help patients return to normal activities sooner without increasing the risk of complications, as shown in studies on ankle and femur fractures. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Immediate WBAT for broken bones?

Research shows that for certain types of fractures, like ankle fractures, patients can safely start putting weight on their leg sooner than usual without affecting recovery. Studies also suggest that early weight-bearing can reduce hospital stay for some fractures, like subtrochanteric femur fractures, without increasing complications. ^{1 2 4 8 9}

Who Is on the Research Team?

Robert O'Toole, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provision of informed consent

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.

Exclusion Criteria

I am not open to being assigned to a treatment by chance.

Non-English Speaking

I understand the study and what will be required of me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to immediate weight bearing as tolerated (WBAT) or delayed WBAT (non-weightbearing for 6-12 weeks) following fracture fixation

6-12 weeks

Follow-up

Participants are monitored for safety and effectiveness, including reoperation and hardware failure, after treatment

6 months

Extended Follow-up

Participants are monitored for long-term outcomes, including maintenance of follow-up and complications

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Immediate WBAT
• No Intervention: Delayed WBAT

Trial Overview 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.

How Is the Trial Designed?

Group I: Immediate WBAT Active Control 1 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 WBAT Active Control 1 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.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

Early weight-bearing after certain lower extremity fractures, particularly in patients with normal protective sensation, can be safe and beneficial, as shown by randomized controlled trials of ankle fractures with no significant outcome differences between immediate and delayed weight bearing.

While immediate weight bearing has low complication rates in specific cases like femoral shaft fractures, the evidence for early weight bearing is less strong for other fracture types, such as periarticular fractures, indicating a need for more research to establish optimal protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early weight bearing after lower extremity fractures in adults. Kubiak, EN., Beebe, MJ., North, K., et al.[2022]

A multicenter study involving 441 patients with subtrochanteric femur fractures found that allowing weight bearing as tolerated (WBAT) post-surgery significantly reduced the length of hospital stay from 9.7 days to 7.4 days without increasing re-operation rates.

The study suggests that immediate WBAT is safe and effective for patients treated with intramedullary fixation, particularly benefiting those aged 41-80 and with specific fracture characteristics, making it a recommended practice if no contraindications exist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate weight bearing as tolerated (WBAT) correlates with a decreased length of stay post intramedullary fixation for subtrochanteric fractures: a multicenter retrospective cohort study. Cunningham, BP., Ali, A., Parikh, HR., et al.[2021]

A study involving 174 patients with ankle fractures found that starting weightbearing at two weeks post-surgery did not lead to a higher complication rate compared to waiting six weeks, suggesting that early weightbearing is safe.

Early weightbearing may enhance patient independence and quality of life without negatively impacting recovery, making it a beneficial option for suitable patients after ankle fracture fixation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of early weightbearing after ankle fracture fixation. de Sa, R., Shah, N., Rudge, B., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Early weight bearing after lower extremity fractures in adults. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect on Overall Health Status With Weightbearing at 2 Weeks vs 6 Weeks After Open Reduction and Internal Fixation of Ankle Fractures. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Immediate weight bearing as tolerated (WBAT) correlates with a decreased length of stay post intramedullary fixation for subtrochanteric fractures: a multicenter retrospective cohort study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Is Immediate Weight-Bearing Safe After Single Implant Fixation of Elderly Distal Femur Fractures? [2021]

5. France pubmed.ncbi.nlm.nih.gov

Safety of early weightbearing after ankle fracture fixation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Early Weightbearing Following Open Reduction and Internal Fixation of Unstable Ankle Fractures on Wound Complications or Failures of Fixation. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of Timing of Postoperative Weight-Bearing on Implant Failure Rate Among Older Patients With Intertrochanteric Hip Fractures: A Propensity Score Matching Cohort Study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Outcomes of early versus delayed weight-bearing with intramedullary nailing of tibial shaft fractures: a systematic review and meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Is Early or Delayed Weightbearing the Better Choice After Microfracture for Osteochondral Lesions of the Talus? A Meta-analysis and Systematic Review. [2021]