Post-Op Rehab Methods for Ankle and Pilon Fractures

Overseen By Eric McVey, MEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Neurological deficits, Non ambulatory, BMI > 50, others

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help people recover from ankle and tibial plafond fractures, which are breaks in the ankle or lower leg. Researchers aim to determine if a simple wooden block stretching exercise (also known as a slant board) can be as effective as traditional physical therapy after surgery. Participants will either use this wooden block protocol or follow a standard rehab routine. Individuals who have undergone surgery for an ankle or lower leg fracture and are ready to try new recovery methods might be a good fit. As an unphased trial, this study offers participants the chance to contribute to innovative recovery methods that could benefit future patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this wooden block stretching device is safe for post-op rehabilitation?

Research on using a wooden block for stretching in ankle and pilon fracture recovery lacks specific safety information. Detailed data on how well people tolerate it or any possible side effects is not yet available. The trial is marked as "Not Applicable" in terms of phase, indicating an early evaluation of this method.

Early trials generally assess a treatment's safety for people. So far, no reports of serious problems have emerged with using a wooden block for rehabilitation. This suggests it might be safe, but further research is needed for confirmation. Prospective participants should ask the trial organizers about any known risks or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a simplified rehabilitation method using a wooden block for post-op recovery from ankle and pilon fractures. Unlike standard care, which often involves formal physical therapy sessions or a home exercise program, this new method emphasizes simplicity and accessibility. The wooden block protocol could make rehabilitation more straightforward and potentially more accessible for patients who may not have easy access to traditional physical therapy resources. This trial could reveal whether this simpler approach is as effective as the more conventional methods, possibly making recovery more efficient and less costly.

What evidence suggests that the wooden block stretching device is effective for post-op rehab of ankle and pilon fractures?

Research has shown that using a wooden block for recovery after surgery can be helpful. In this trial, participants in the "Simplified block protocol" arm will use a wooden block to perform a simplified post-operative rehabilitation program. Studies indicate that this method improves flexibility and movement by focusing on stretching. It specifically aims to enhance ankle dorsiflexion, which involves bending the foot upward, to support recovery. A similar technique using a slant board improved walking in other conditions, suggesting it could also benefit ankle recovery. Overall, the wooden block method appears to be a promising alternative to traditional physical therapy, which participants in the "Usual care" arm will receive. ^{1 2 3 6 7}

Who Is on the Research Team?

Seth Yarboro, MD

Principal Investigator

University of Virginia Orthopaedic Surgey

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-65 who have had surgery to fix broken bones in the ankle or lower leg. It's not suitable for those with severe injuries needing complex reconstruction, balance issues due to neurological deficits, a high BMI over 50, previous similar injuries on the same side, or conditions that prevent weight-bearing after six weeks.

Inclusion Criteria

I had surgery for a broken ankle or lower shin.

Exclusion Criteria

I have a severe injury needing special surgery to cover the wound or fix blood vessels.

I have injuries on the opposite leg that prevent me from putting weight on it.

I was unable to walk before my injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-operative Rehabilitation

Participants begin rehabilitation with either a simplified wooden block protocol or standard physical therapy following splint removal

6 weeks

3 standard post-operative visits

Follow-up

Participants are monitored for ankle range of motion, pain, and functional outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Wooden block

Trial Overview The study is testing if a simple home exercise program using a wooden block can match standard post-op rehab results for people recovering from ankle and lower leg fractures. Participants will either receive formal physical therapy or do exercises at home.

How Is the Trial Designed?

Group I: Simplified block protocol Experimental Treatment 1 Intervention

subjects in this group will perform a simplified post operative rehabilitation program using a simplified wooden block protocol

Group II: Usual care Active Control 1 Intervention

Subjects in this group will perform formal physical therapy or a home exercise program consistent with AAOS standards.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

Pilon fractures, which affect the weight-bearing part of the ankle joint, require careful assessment using computed tomography and evaluation of soft tissue damage before surgical intervention.

The surgical treatment focuses on preserving the joint and prioritizes soft tissue repair, utilizing local approaches and techniques like joint distraction and early non-weight bearing mobilization to promote recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pilon fractures]. Klaue, K., Cronier, P.[2022]

Open reduction and internal fixation, following AO/ASIF principles, significantly improves outcomes for high-grade pilon fractures compared to traditional closed treatment methods, which often yield unsatisfactory results.

Successful surgical intervention involves careful restoration of the fibula, reconstruction of the joint surface, and addressing any metaphyseal defects, leading to predictably good results in most cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilon fractures of the distal tibia. Ruwe, PA., Randall, RL., Baumgaertner, MR.[2005]

A case report demonstrates the successful use of an anterior cruciate ligament targeting device in a minimally invasive technique for treating a complex tibial pilon fracture, which is typically challenging due to high-energy trauma.

The procedure was performed under arthroscopic and fluoroscopic guidance, highlighting the importance of precision and care for surrounding soft tissues in achieving accurate joint reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive reduction technique in split depression type tibial pilon fractures. Poyanli, O., Esenkaya, I., Ozkut, AT., et al.[2016]

In a study of 20 knees from 17 patients undergoing medial opening wedge high tibial osteotomy (MOW HTO) with a PEEK intraosseous implant, 95% achieved bone union by 6 months, demonstrating that accelerated rehabilitation does not delay recovery.

Patients reported significant improvements in knee function and satisfaction after 38 months, with scores indicating a return to daily activities, suggesting that this approach is effective for certain patients, particularly those with less severe preoperative varus alignment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early results of medial opening wedge high tibial osteotomy using an intraosseous implant with accelerated rehabilitation. Morris, J., Grant, A., Kulkarni, R., et al.[2021]

The modified anatomic locking plate used in 11 patients with posteromedial tibial plateau fractures demonstrated effective clinical outcomes, with all patients achieving radiological fracture union by 14 weeks and no reported complications such as infection or fixation failure during a follow-up period of up to 60 months.

Functional scores at the final follow-up indicated good recovery, with Tegner-Lysholm scores ranging from 80 to 96 and no instances of knee instability or severe pain, suggesting that this surgical method is both safe and effective for treating these types of fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Anatomic Locking Plate for the Treatment of Posteromedial Tibial Plateau Fractures. Jian, Z., Ao, RG., Zhou, JH., et al.[2021]

In a study of 96 patients with pilon and unstable ankle fractures, applying an external fixator (ex-fix) in the emergency department (ED) showed no significant difference in postoperative complications compared to those applied in the operating room (OR).

Both groups had similar rates of deep infections and need for revision of the ex-fix, suggesting that ex-fix application in the ED is a safe alternative to the OR for these types of fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Fixation in the Emergency Department for Pilon and Unstable Ankle Fractures. Shah, KN., Johnson, JP., OʼDonnell, SW., et al.[2019]

In a study of 44 patients with pilon fractures, both the anterolateral and posterolateral surgical approaches showed similar peri-operative and post-operative outcomes, including pain scores and range of motion, indicating that either approach can be safely used based on the specific injury.

There was a trend suggesting that patients who underwent the posterolateral approach required more outpatient opioid medications for pain control post-surgery, although this was not statistically significant (p=0.09).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical fixation of pilon injuries: a comparison of the anterolateral and posterolateral approach. Malige, A., Yeazell, S., Nwachuku, C.[2019]

A study of 69 patients with pilon fractures showed that categorizing fractures based on ankle position at the time of injury can lead to effective surgical strategies, with over 90% achieving good fracture reduction in most groups.

Patients with fractures in dorsiflexion and plantarflexion positions had significantly better healing and higher AOFAS scores compared to those in neutral position, indicating that initial fracture displacement direction impacts recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of pilon fracture based on ankle position at the time of injury/initial direction of fracture displacement: a prospective cohort study. Wei, SJ., Han, F., Lan, SH., et al.[2022]

A case study of a tibial pilon fracture treated with a transfibular surgical approach showed successful recovery, allowing full weightbearing 8 weeks post-surgery after an initial 3-week nonweightbearing period.

At the two-year follow-up, the patient exhibited no signs of degeneration and maintained full range of motion in the ankle, indicating effective treatment and positive long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lateral Transfibular Approach to Tibial Pilon Fractures: A Case Report. Tosun, B., Selek, O.[2020]

In a study of 58 patients with pilon fractures and ankle dislocation, anatomic reduction was successfully achieved in 67.24% of cases, indicating effective surgical intervention for these complex injuries.

The overall rate of good or excellent ankle recovery was high, at 84% for type B fractures and 75.76% for type C fractures, suggesting that restoring the original anatomy and alignment is crucial for minimizing complications and promoting healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathogenesis and Treatment Strategies for Pilon Fractures With Ankle Dislocation. Song, Z., Xue, HZ., Zhang, K., et al.[2016]

Patients using the new ankle trainer device showed significantly better short-term recovery, with higher Olerud-Molander ankle scores at 3 weeks compared to those receiving conventional physiotherapy (40.9 vs. 35.3).

The ankle trainer group also experienced a shorter hospital stay, averaging 2.6 days compared to 3.2 days for the conventional group, indicating a more efficient recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compared to conventional physiotherapy, does the use of an ankle trainer device after Weber B ankle fracture operation improve outcome and shorten hospital stay? A randomized controlled trial. Molund, M., Hellesnes, J., Berdal, G., et al.[2022]

A new minimally invasive surgical procedure for treating pylon fractures was developed, which involves indirect reduction and stabilization of the fibula using intramedullary Kirschner wires and ligamentotaxis for the tibial articular surface, allowing for precise alignment without additional stress to surrounding soft tissue.

In three cases of type C2 pilon fractures, the procedure resulted in successful healing within 12 weeks without complications, and the range of motion in the ankle joint was preserved through physiotherapy, indicating both safety and efficacy of the approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Primary closed, stabilization of type C 3 pilon fractures with external fixator without bridging the ankle joint]. Vrabl, M.[2019]

In a study of 35 knees from 34 patients who underwent medial open wedge high tibial osteotomy (MOWHTO) with the Anthony-K plate, significant improvements were observed in pain and function scores (VAS, WOMAC, and Lysholm) after a minimum of five years (p < 0.001).

The Anthony-K plate provided effective and stable correction of knee alignment, with a mean correction angle of 13.1° and a high plate survival rate of 97.2%, while maintaining stability until the osteotomy healed, with a low overall complication rate of 8.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiographic outcomes of medial open-wedge high tibial osteotomy with Anthony-K plate: prospective minimum five year follow-up data. Altay, MA., Ertürk, C., Altay, N., et al.[2019]

The new anatomical locking metal block plate provided significantly higher biomechanical stability for open wedge high tibial osteotomy (HTO) compared to plates without a metal block, with the highest yield and ultimate loads recorded in the group using the metal block (1829 N and 3493 N, respectively).

The addition of the metal block also resulted in less displacement of the osteotomy gap (0.34 mm) and allowed for a greater number of cycles to failure (42,816 cycles at 1,330 N), indicating enhanced durability and stability during loading compared to other fixation constructs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical properties of a new anatomical locking metal block plate for opening wedge high tibial osteotomy: uniplane osteotomy. Han, SB., Bae, JH., Lee, SJ., et al.[2022]

The protective cutting system (PCS) used in open-wedge high tibial osteotomy (OWHTO) significantly improved the accuracy of osteotomies, particularly at the posterior cortex, compared to conventional techniques, as shown in a study of 35 patients (19 with PCS and 16 with conventional methods).

Patients undergoing OWHTO with the PCS experienced fewer intraoperative complications, such as fractures and deviations in the osteotomy plane, highlighting the safety benefits of this new surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of osteotomy accuracy between the conventional and devised technique using a protective cutting system in medial open-wedge high tibial osteotomy. Lee, YS., Moon, GH.[2022]

Citations

1. ctv.veeva.com ctv.veeva.com/study/simplified-post-op-rehabilitation-for-ankle-and-pilon-fractures

Simplified Post Op Rehabilitation for Ankle and Pilon Fractures The aim of this study is to compare the standard post injury/surgery rehabilitation with this new simplified wooden block stretching protocol ...

2. withpower.com withpower.com/trial/phase-pilon-fractures-11-2022-eb7dd

Post-Op Rehab Methods for Ankle and Pilon Fractures The wooden block stretching device is unique because it focuses on post-operative rehabilitation by promoting flexibility and range of motion through stretching ...

3. med.virginia.edu med.virginia.edu/orthopaedic-surgery/wp-content/uploads/sites/242/2020/06/BACKLUND-RRD-2020.pdf

Ankle and Pilon Fracture Post Operative Rehabilitation We seek to explore a simplified home ankle rehabilitation protocol centered around ankle dorsiflexion with a wooden block, with goal of improving ankle ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5011595/

Effect of home-based training using a slant board with ... This study showed that home-based training using a slant board is safe and significantly improves walking function in post-stroke hemiparetic patients.

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD005595.pub4/references

Rehabilitation for ankle fractures in adults - Lewis, SR - 2024 Compared to conventional physiotherapy, does the use of an ankle trainer device after Weber B ankle fracture operation improve outcome and shorten hospital stay ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11418975/

Rehabilitation for ankle fractures in adults - PMC We collected data for five outcomes: activity limitation (ankle function), health‐related quality of life (HRQoL), participant satisfaction with treatment, pain ...

7. mdpi.com mdpi.com/2075-1729/13/11/2187

Comparison between Exercise Program–Foot Orthoses ... To date, this will be the first study to assess both the properties of ankle muscles and foot kinematics after tibial pilon fracture surgery.