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

Trial Summary

What is the purpose of this trial?

This trial compares standard post-surgery rehabilitation with a new wooden block stretching protocol for patients with ankle fractures. The goal is to see if the simpler wooden block exercises can effectively reduce stiffness and improve ankle movement. The study will measure pain, compliance, and ankle function over several follow-up periods.

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 data supports the idea that Post-Op Rehab Methods for Ankle and Pilon Fractures is an effective treatment?

The available research does not provide specific data on the effectiveness of Post-Op Rehab Methods like the wooden block or slant board for ankle and pilon fractures. However, one study compared a new ankle trainer device to conventional physiotherapy for Weber B ankle fractures, suggesting that alternative methods are being explored. For pilon fractures, the studies focus on surgical strategies and fixation methods rather than post-op rehab techniques. Therefore, there is no direct evidence from the provided research supporting the effectiveness of these specific rehab methods for ankle and pilon fractures. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment methods used in the Post-Op Rehab Methods for Ankle and Pilon Fractures trial?

The research on the use of an ankle trainer device after Weber B ankle fractures suggests that specialized devices can improve functional outcomes and potentially shorten hospital stays. While this study does not directly evaluate wooden blocks or slant boards, it indicates that targeted rehabilitation tools can be beneficial in ankle recovery. ^{1 2 3 4 5}

What safety data exists for the Wooden block stretching device used in post-op rehab for ankle and pilon fractures?

The provided research does not contain specific safety data for the Wooden block stretching device, Slant board, or similar devices used in post-op rehab for ankle and pilon fractures. The studies focus on high tibial osteotomy techniques and devices, which are unrelated to the treatment in question. ^{6 7 8 9 10}

Is the treatment Wooden block a promising treatment for ankle and pilon fractures?

The research articles focus on surgical methods for treating pilon fractures, but they do not mention the Wooden block treatment. Therefore, based on the provided information, we cannot determine if the Wooden block is a promising treatment for ankle and pilon fractures. ^{11 12 13 14 15}

How does the wooden block stretching device treatment differ from other treatments 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, which is different from surgical methods that focus on bone alignment and stabilization. This approach may complement surgical treatments by aiding in recovery and improving joint mobility. ^{11 12 13 14 15}

Research Team

Seth Yarboro, MD

Principal Investigator

University of Virginia Orthopaedic Surgey

Eligibility Criteria

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 am between 18 and 65 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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 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]

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]

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]

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]

References

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

Pathogenesis and Treatment Strategies for Pilon Fractures With Ankle Dislocation. [2016]

2. United States 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. [2022]

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

External Fixation in the Emergency Department for Pilon and Unstable Ankle Fractures. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Surgical fixation of pilon injuries: a comparison of the anterolateral and posterolateral approach. [2019]

5. England 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. [2022]

6. Japan 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. [2022]

7. Germany 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. [2019]

8. France pubmed.ncbi.nlm.nih.gov

Early results of medial opening wedge high tibial osteotomy using an intraosseous implant with accelerated rehabilitation. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Biomechanical properties of a new anatomical locking metal block plate for opening wedge high tibial osteotomy: uniplane osteotomy. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Modified Anatomic Locking Plate for the Treatment of Posteromedial Tibial Plateau Fractures. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

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

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

Lateral Transfibular Approach to Tibial Pilon Fractures: A Case Report. [2020]

13. Germany pubmed.ncbi.nlm.nih.gov

[Pilon fractures]. [2022]

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

Pilon fractures of the distal tibia. [2005]

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

Minimally invasive reduction technique in split depression type tibial pilon fractures. [2016]