Trial Summary
What is the purpose of this trial?The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study.
Is Early Weight Bearing a promising treatment for ankle fractures?Yes, Early Weight Bearing is a promising treatment for ankle fractures. It allows patients to walk and return to daily activities faster, improves short-term ankle function, and is generally safe without increasing long-term complications.12356
What safety data exists for early weight bearing after ankle fracture?Several studies suggest that early weight bearing after ankle fracture fixation can be safe for certain patients. Immediate weight-bearing as tolerated (IWBAT) showed low complication rates, with only 1 out of 26 patients experiencing loss of fixation due to a missed injury. Other studies found no significant differences in long-term outcomes between early and delayed weight bearing, although early weight bearing improved short-term ankle function. However, early mobilization may increase the risk of postoperative complications. Overall, early weight bearing can be a safe alternative for specific fracture patterns, but further research is needed to refine protocols.23456
What data supports the idea that Early Weight Bearing for Ankle Fracture is an effective treatment?The available research shows that Early Weight Bearing (EWB) for ankle fractures can be effective. One study found that patients who started walking immediately after surgery had better short-term ankle function compared to those who waited. Another study reported that most patients could wear normal shoes just six weeks after surgery, with only one out of 26 patients experiencing a problem with the surgical fix. Additionally, a review of several studies found no significant long-term differences between early and delayed weight bearing, suggesting that EWB can be a safe option. Overall, these studies indicate that EWB can help patients recover faster without increasing the risk of complications.12356
Do I have to stop taking my current medications for the trial?The protocol does not specify if you need to stop taking your current medications. However, if you are on osteoporosis medications like bisphosphonates, Prolia, or Forteo, you are not eligible for the trial.
Eligibility Criteria
Adults over 18 with certain types of ankle or tibial plateau fractures that have been surgically treated can join this trial. Excluded are those with severe soft tissue injuries, syndesmotic injuries, upper limb weight-bearing limitations, morbid obesity (BMI ≥40), psychiatric disorders affecting compliance, and other conditions like neuropathy or osteoporosis.Inclusion Criteria
I had surgery for a specific type of broken ankle or lower leg bone.
Exclusion Criteria
I have severe burns on more than 10% of my body, including the limb being studied.
I have injuries that prevent me from putting weight on my arms or legs.
I have nerve damage or a broken bone due to cancer.
I have osteoporosis, confirmed by medication use or a past weak-bone fracture.
I have had surgery to fix an injury in my ankle joint.
I have a severe injury to my leg that prevents me from putting weight on it.
Treatment Details
The study is examining the effects of allowing patients to put weight on their leg early after surgery for an ankle fracture without syndesmotic fixation or a specific type of tibial plateau fracture. It compares early versus delayed weight bearing in terms of rehabilitation outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Weight BearingExperimental Treatment1 Intervention
Patients with ankle fractures will be instructed to weight bear as tolerated (WBAT) while in a boot with a heel to toe normal gait and wean from walker or crutches to a cane or no support device. At the 6 week post op visit, patients with ankle fractures will be instructed to wean from the boot and continue full weight bearing as tolerated until full weight bearing is achieved. Patients with plateau fractures will be instructed to begin WBAT until full weight bearing is achieved.
Group II: Delayed Weight BearingActive Control1 Intervention
Patients with ankle fractures will be instructed to touch-down (toe touch or foot flat) weight bear (approximately 10% of body weight) while in the boot for. Patients will be instructed to keep foot off of floor or set ball of foot or heal on ground for balance using walker or crutches at all times. After the 6 week post op visit, patients may begin weight bearing as tolerated. Patients with tibial plateau fractures will be instructed to touch down (toe touch or foot flat) weight bear (approximately 10% of body weight) for at least 6 weeks. After the 6 week post op visit, patients may begin weight bearing as tolerated until full weight bearing is achieved.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Pittsburgh Medical CenterPittsburgh, PA
University of Washington/Harborview Medical CenterSeattle, WA
Carolinas Medical CenterCharlotte, NC
Methodist HospitalIndianapolis, IN
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Who is running the clinical trial?
Major Extremity Trauma Research ConsortiumLead Sponsor
References
Successful immediate weight-bearing of internal fixated ankle fractures in a general population. [2022]Several studies on operated ankle fractures have shown that immediate weight-bearing is recommendable. Consequently, we changed our postoperative standard regimen, from 3 weeks of non-weight-bearing followed by 3 weeks of weight-bearing, to full immediate weight-bearing in all 6 weeks. A below-knee walking cast was applied immediately after surgery. Between December 1995 and September 1996, we studied 62 patients (median age, 55 years; range 21-92 years; M/F, 24/38), with ankle fractures who attended our emergency department and were subsequently admitted for open reduction and internal fixation. We excluded patients with distal tibia fracture and patients under 18 years of age. Overall, our elderly population did not have complication rates higher than those reported in similar studies on younger patients. In 1 patient, we observed radiographic widening of the ankle joint, of about 3 mm, 6 weeks postoperatively. No patients required reoperation. Our study indicates that full immediate weight-bearing after open reduction and internal fixation is recommendable, even in an elderly population.
Early weight bearing after lower extremity fractures in adults. [2022]Weight-bearing protocols should optimize fracture healing while avoiding fracture displacement or implant failure. Biomechanical and animal studies indicate that early loading is beneficial, but high-quality clinical studies comparing weight-bearing protocols after lower extremity fractures are not universally available. For certain fracture patterns, well-designed trials suggest that patients with normal protective sensation can safely bear weight sooner than most protocols permit. Several randomized, controlled trials of surgically treated ankle fractures have shown no difference in outcomes between immediate and delayed (≥6 weeks) weight bearing. Retrospective series have reported low complication rates with immediate weight bearing following intramedullary nailing of femoral shaft fractures and following surgical management of femoral neck and intertrochanteric femur fractures in elderly patients. For other fracture patterns, particularly periarticular fractures, the evidence in favor of early weight bearing is less compelling. Most surgeons recommend a period of protected weight bearing for patients with calcaneal, tibial plafond, tibial plateau, and acetabular fractures. Further studies are warranted to better define optimal postoperative weight-bearing protocols.
Immediate weight-bearing after ankle fracture fixation. [2020]We believe that a certain subset of surgical ankle fracture patients can be made weight-bearing as tolerated immediately following surgery. Immediate weight-bearing as tolerated (IWBAT) allows patients to return to ambulation and activities of daily living faster and may facilitate rehabilitation. A prospectively gathered orthopaedic trauma database at a Level 1 trauma center was reviewed retrospectively to identify patients who had ORIF after unstable ankle injuries treated by the senior author. Patients were excluded if they were not IWBAT based on specific criteria or if they did meet followup requirement. Only 1/26 patients was noted to have loss of fixation. This was found at the 6-week followup and was attributed to a missed syndesmotic injury. At 2-week followup, 2 patients had peri-incisional erythema that resolved with a short course of oral antibiotics. At 6-week followup, 20 patients were wearing normal shoes and 6 patients continued to wear the CAM Boot for comfort. To conclude, IWBAT in a certain subset of patients with stable osteosynthesis following an ankle fracture could potentially be a safe alternative to a period of protected weight-bearing.
Quality of life and complications in elderly patients after pronation rotation type III ankle fractures treated with a cast and early weight-bearing. [2021]Early weight-bearing is becoming increasingly common because it can positively affect the quality of life of patients. Therefore, the efficacy and safety of this conservative treatment should be assessed for different types of ankle fractures. The goal of this study was to compare early weight-bearing and non-weight-bearing in terms of effectiveness and safety in patients with pronation rotation type III ankle fractures treated nonsurgically.
Early Versus Delayed Weight Bearing and Mobilization After Ankle Fracture Fixation Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]The purpose of this review was to determine whether there is a benefit to early weight bearing or mobilization in surgically treated ankle fractures. All randomized controlled trials that analyzed early vs delayed weight bearing and/or mobilization after an ankle surgery were included. The primary outcome measure was the pooled Olerud Molander Ankle Score 1 year postoperatively. No significant differences in ankle function were found at 1 year postoperatively between early and delayed weight bearing and mobilization. The 12-week results demonstrated superior early ankle function scores for patients who had early weight bearing. Patients who had early mobilization were at increased risk for postoperative complications. In surgically treated ankle fractures, early weight bearing resulted in improved short-term ankle function scores. [Orthopedics. 202x;4x(x):xx-xx.].
Safety of early weightbearing after ankle fracture fixation. [2023]Patients with surgically treated ankle fractures are traditionally kept non-weightbearing for at least six weeks post-operatively; however, recent literature suggests numerous benefits of early weightbearing (EWB) before six weeks without significantly impacting long-term outcomes. This study aims to review the safety of early vs late weightbearing following ankle fracture fixation by assessing the complication rate.