Early vs Delayed Weight-Bearing for Ankle Injury

Recruiting at 1 trial location

Overseen By Stacee Clawson, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kyle Schweser MD

Disqualifiers: Diabetes, Renal disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Delayed/Late Weight-Bearing, Early Weight-Bearing for ankle injury?

Research shows that early weight-bearing after ankle surgery can lead to better short-term ankle function, although there is no significant difference in long-term outcomes compared to delayed weight-bearing. However, early mobilization may increase the risk of complications, suggesting that the timing of weight-bearing should be carefully considered. ^{1 2 3 4 5}

Is early weight-bearing after ankle injury surgery safe?

Research shows that early weight-bearing after ankle surgery is generally safe and can improve short-term ankle function, although it may increase the risk of some complications. Overall, early weight-bearing does not significantly impact long-term outcomes compared to delayed weight-bearing. ^{1 2 3 6 7}

How does early vs delayed weight-bearing treatment for ankle injury differ from other treatments?

The early vs delayed weight-bearing treatment for ankle injuries is unique because it focuses on the timing of when patients start putting weight on their injured ankle after surgery. Early weight-bearing can improve short-term ankle function, but it may increase the risk of complications, while delayed weight-bearing does not significantly affect long-term outcomes. ^{1 2 7 8 9}

What is the purpose of this trial?

A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic disruption. There is very little literature on time to weight bearing, with most available series casting/immobilizing these injuries for 6 weeks after fixation. There is very little data examining post-operative weight bearing after syndesmotic stabilization, and the majority centers on screw fixation. The minimum time to weight bearing after an ankle fracture with syndesmotic fixation in the literature is 4 weeks, with most focusing on 6 to 12 weeks. Based on biomechanical data regarding suture button techniques, the investigators hypothesize that patients undergoing ankle fracture fixation plus suture button fixation of their syndesmotic disruption will be able to safely bear weight early (2 weeks) after surgery. The investigator's null hypothesis is that there will be no difference between early weight bearing (2 weeks), and late weight bearing (6 weeks) in terms of outcome, hardware failure, loss of reduction, and return to work. Adult patients who have an ankle fracture with suspected syndesmotic disruption, requiring a suture button fixation operative intervention will be randomized into early (2 weeks post-surgically) weight-bearing status or delayed weight-bearing status (non-weight-bearing for 6 weeks following fixation). Primary objective: Maintenance of ankle reduction at 1 year follow-up (measured by comparing immediate post-op CT and 1 year time-point CT). Secondary Objectives: Pain scores, surgical experience, work productivity and activity impairment , AAOS foot and ankle scores (2w, 6w, 12w, 6m, 1y), use of assistive devices, range of motion, physical therapy requirement/length of use/compliance, post-operative protocol compliance, post-operative complications (wound healing, infection, implant failure, fracture healing).

Research Team

Kyle Schweser, MD

Principal Investigator

University of Missouri Health System, Department of Orthopaedic Surgery

Eligibility Criteria

Adults over 18 who can walk on their own and have an ankle fracture with a suspected syndesmotic injury, likely needing suture button surgery. Not for pregnant or breastfeeding individuals, those under 18, weighing over 325 pounds, prisoners, people unable to follow commands due to conditions like dementia or TBI, patients with end-stage renal disease, severe syndesmotic injuries (Maisonneuve), or neuropathic diabetics.

Inclusion Criteria

I have a broken ankle that may need surgery with a special suture technique.

I can walk on my own before surgery.

Exclusion Criteria

You are currently pregnant or breastfeeding.

Prisoner

I have a specific type of ankle injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical suture button fixation for syndesmotic disruption and are randomized into early or delayed weight-bearing groups

6 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including maintenance of ankle reduction and secondary outcomes

1 year

Visits at 2 weeks, 6 weeks, 12 weeks, 6 months, and 1 year

Treatment Details

Interventions

• Delayed/Late Weight-Bearing
• Early Weight-Bearing

Trial Overview The study is testing if patients with ankle fractures involving the syndesmosis can safely put weight on their foot early (2 weeks after surgery) versus late (6 weeks). They're randomly assigned to one of these two groups. The main goal is seeing if the position of the bones stays correct after a year using CT scans.

Participant Groups

Group I: Early Weight-Bearing Active Control 1 Intervention

Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption

Group II: Delayed/Late Weight-Bearing Active Control 1 Intervention

Being directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption

Who Is Running the Clinical Trial?

Kyle Schweser MD

Lead Sponsor

Trials

3

Recruited

120+

Findings from Research

Early weight bearing after ankle surgery leads to better short-term ankle function scores at 12 weeks, suggesting it may be beneficial for recovery in the initial phase.

However, despite these short-term benefits, there were no significant differences in overall ankle function at 1 year post-surgery between early and delayed weight bearing, and early mobilization was associated with a higher risk of postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Versus Delayed Weight Bearing and Mobilization After Ankle Fracture Fixation Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Tong, J., Ajrawat, P., Chahal, J., et al.[2023]

Weight bearing (WB) and mobilization (MB) after surgical treatment for ankle fractures do not increase complication rates and lead to better short-term outcomes in terms of ankle function and return to work, based on a systematic review of 24 studies involving 1,559 participants.

Compared to non-weight bearing (NWB) and immobilization (IMB), WB and MB resulted in superior scores on the Olerud and Molander Ankle Score (OMAS) and improved range of motion (ROM), indicating that early activity is beneficial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate weight bearing without immobilization for operatively treated ankle fractures is safe - A systematic review. Baumbach, SF., Rellensmann, K., Spindler, FT., et al.[2023]

Early weight-bearing after common foot and ankle surgeries, such as metatarsophalangeal joint arthrodesis and ankle fractures, is supported by literature as a safe alternative to prolonged immobilization.

Prolonged nonweight bearing can lead to serious complications like deep vein thrombosis and cardiovascular issues, making early weight-bearing protocols a beneficial approach for postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Functional Rehabilitation in Foot and Ankle Surgery. Patel, S., Dionisopoulos, SB., Schmalhaus, MJ.[2023]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

When Should Open Reduction and Internal Fixation Ankle Fractures Begin Weight Bearing? A Systematic Review. [2016]

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

Early Versus Delayed Weight Bearing and Mobilization After Ankle Fracture Fixation Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]

3. Iran pubmed.ncbi.nlm.nih.gov

Early Unprotected Weight Bearing and Pre-Scheduled Supervised Rehabilitation Program after Surgical Treatment of Ankle Fractures. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Immediate weight bearing without immobilization for operatively treated ankle fractures is safe - A systematic review. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A novel tool for continuous fracture aftercare - Clinical feasibility and first results of a new telemetric gait analysis insole. [2022]

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

Early Functional Rehabilitation in Foot and Ankle Surgery. [2023]

7. France pubmed.ncbi.nlm.nih.gov

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

8. Scotland pubmed.ncbi.nlm.nih.gov

Early versus late weight-bearing in operatively treated ankle fractures with syndesmotic injury: A systematic review. [2023]

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

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