Immediate vs Delayed Weightbearing for Broken Bones

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of immediate weight-bearing as tolerated (Immediate WBAT) for individuals with certain leg, pelvis, or hip fractures, compared to delayed weight-bearing (Delayed WBAT) several weeks post-surgery. Researchers aim to determine if earlier mobility can lead to faster recovery and fewer complications. Suitable participants include those who have undergone surgery for a lower body fracture and can understand and follow study instructions. As an unphased trial, this study provides an opportunity to contribute to valuable research that could enhance recovery processes for future patients.

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.

What prior data suggests that immediate weight bearing is safe for lower extremity, pelvis, and acetabulum fractures?

Research shows that starting to put weight on the legs as soon as possible might be safe for individuals with fractures in the lower body, such as the legs, pelvis, and hip socket. Studies have found that this approach can help individuals move around and return to normal activities faster. It can also prevent issues like muscle weakening, which often occurs when weight cannot be placed on the legs.

Recent evidence suggests that early weight-bearing is often safely used for other fractures, such as those in the hip and leg. However, more high-quality research is needed to confirm these findings for the specific fractures under study. So far, early weight-bearing seems promising in aiding quicker recovery without causing additional harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the benefits of allowing patients to bear weight immediately after surgery for certain fractures, as opposed to the usual delayed approach. Immediate weight-bearing as tolerated (WBAT) could expedite patient mobility and speed up recovery, which is especially beneficial in reducing complications and hospital stays, particularly for older patients. By potentially proving that early weight-bearing is safe and effective, this trial could lead to a shift in how recovery is managed for lower extremity and pelvic fractures, ultimately improving patient outcomes and quality of life.

What evidence suggests that immediate WBAT is effective for fractures?

This trial will compare immediate weight-bearing as tolerated (WBAT) with delayed WBAT for patients with certain lower body fractures. Studies have shown that starting to put weight on an injured leg as soon as tolerable might speed up healing and return to activities. Research suggests that walking or putting weight on the leg soon after surgery could accelerate recovery and reduce complications. Early weight-bearing has been linked to benefits like quicker recovery and improved movement. However, evidence from past studies remains limited, and more high-quality research is needed to fully understand its safety and effectiveness compared to the traditional approach of delaying weight-bearing. ^{1 3 4 6 7}

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.

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

Non-English Speaking

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

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8477081/

Early weight bearing in acetabular and pelvic fractures - PMC On the other hand, early weight bearing may stimulate fracture healing and allow prompt functional recovery, faster return to work and recreational activities ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05595148

NCT05595148 | Immediate Weightbearing vs Delayed ... Recent studies have highlighted that early WBAT may be safe following fixation of lower extremity, pelvis, and acetabulum fractures where the standard of care ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12412364/

Early weight-bearing after acetabular fractures in the older ... Albeit limited and low in evidence, the included studies suggest that early weight-bearing might be a possible alternative for non- or minimally ...

4. researchgate.net researchgate.net/publication/387241768_Immediate_versus_delayed_weight_bearing_for_fractures_of_the_pelvis_acetabulum_distal_femur_and_proximal_and_distal_tibia_a_feasibility_randomized_controlled_trial?_tp=eyJjb250ZXh0Ijp7InBhZ2UiOiJzY2llbnRpZmljQ29udHJpYnV0aW9ucyIsInByZXZpb3VzUGFnZSI6bnVsbCwic3ViUGFnZSI6bnVsbH19

Immediate versus delayed weight bearing for fractures of ... Adult patients with a surgically treated lower-extremity fracture were included. The primary outcome was self-reported financial distress.

5. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07189156

Weight Bearing After Pelvis and Acetabulum Fracture Fixation Early weight bearing has been shown to be associated with a number of benefits following fixation of various lower extremity fractures, and ...

6. trial.medpath.com trial.medpath.com/clinical-trial/f0950f98208d90c8/nct07189156-weight-bearing-pelvis-acetabulum-fractures-randomized-trial

Weight Bearing After Pelvis and Acetabulum Fracture Fixation Early weight bearing has been shown to be associated with a number of benefits following fixation of various lower extremity fractures, and ...

7. ctv.veeva.com ctv.veeva.com/study/immediate-weightbearing-vs-delayed-weightbearing

Immediate Weightbearing vs Delayed Weightbearing Recent studies have highlighted that early WBAT is may be safe following fixation of lower extremity, pelvis, and acetabulum fractures where the ...