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

Trial Summary

What is the purpose of this trial?

High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis. Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury. This project will study the effect of joint lavage on the concentration of inflammatory cytokines in the ankle following a high-energy tibial pilon fracture and the resultant effect on short-term patient outcomes.

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 data supports the effectiveness of the treatment Joint Lavage for Ankle Fractures?

Research shows that joint lavage, which involves washing out a joint with fluid, is effective in reducing bacteria and treating infections in various joints, such as the knee and hip. This suggests it could help clean and potentially improve healing in ankle fractures as well. ^{1 2 3 4 5}

Is joint lavage generally safe for humans?

Joint lavage is generally considered safe, but using high-irrigation pressure can cause complications like bone damage or delayed healing in surgeries. It's important to use appropriate pressure to avoid these issues. ^{1 2 4 6 7}

How is the treatment Joint Lavage for ankle fractures different from other treatments?

Joint Lavage is unique because it involves flushing the joint with a sterile saline solution to clean it, which can help reduce bacteria and debris. This method is different from other treatments that might focus on immobilization or surgical repair, as it directly targets the joint environment to potentially aid in healing and reduce infection risk. ^{1 2 5 8 9}

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of the efficacy of joint lavage versus joint lavage plus corticoids in patients with osteoarthritis of the knee. [2010]

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

Lavage of contaminated surfaces: an in vitro evaluation of the effectiveness of different systems. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of septic arthritis of the hip in children and adolescents]. [2013]

4. United States 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. [2021]

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

Treatment of infection with improved pulsed lavage. [2015]

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

Assessment of the efficacy of joint lavage in rabbits with osteoarthritis of the knee. [2010]

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

Is There a Role for Preclosure Dilute Betadine Irrigation in the Prevention of Postoperative Infection Following Total Joint Arthroplasty? [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Use of lavage fluids in arthroplasty to prevent postoperative infections. [2014]