Saline Lavage for Ankle Fracture

Overseen By Jennifer Friend

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Age < 18, Open fracture, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 0-48 hours

41 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the effect of early, percutaneous, intra-articular saline lavage on the undiluted synovial fluid microenvironment during the acute phase following intra-articular fracture of the human ankle. We hypothesize that early intervention with percutaneous joint lavage in the first 0-48 hours after injury will attenuate the production of pro-inflammatory cytokines, MMP's and cartilage breakdown products compared to non-lavaged control subjects at the time of surgical fixation.

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 Saline Lavage for Ankle Fracture?

Research shows that saline lavage, a technique where sterile saline is used to clean joints, has been effective in treating conditions like osteoarthritis and rheumatoid arthritis by reducing symptoms and preventing infections. This suggests it may also help in cleaning and promoting healing in ankle fractures. ^{1 2 3 4 5}

Is saline lavage generally safe for use in humans?

Saline lavage is generally considered safe, but there are rare risks such as venous air embolism (air bubbles in the bloodstream) as seen in a patient with Paget's disease. In a study on peritonitis, saline lavage did not increase complications compared to antiseptic solutions. ^{1 3 6 7 8}

How is the treatment Saline Lavage for Ankle Fracture different from other treatments?

Saline Lavage is unique because it involves flushing the joint with a sterile saltwater solution to clean and potentially aid in healing, unlike other treatments that might focus on immobilization or surgical intervention. This method is similar to its use in other conditions like osteoarthritis, where it helps to clean the joint area, but it is not a standard treatment for ankle fractures. ^{1 2 3 5 9}

Research Team

Samuel Adams, MD

Principal Investigator

Duke Health

Eligibility Criteria

This trial is for adults over 18 who have a specific type of ankle fracture where the break extends into the joint surface, and are treated at Duke University Hospital within 48 hours of injury. It's not for those with open fractures, injuries older than 48 hours, or non-surgical cases.

Inclusion Criteria

I am over 18 years old.

Must be treated at Duke University Hospital Emergency Department

I got injured within the last 48 hours.

Exclusion Criteria

I have a broken bone that is exposed through my skin.

I sought medical help more than 48 hours after my injury.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

0-48 hours

1 visit (in-person)

Treatment

Participants receive intra-articular saline lavage or no lavage within 0-48 hours of injury

0-48 hours

1 visit (in-person)

Surgical Fixation

Participants undergo surgical fixation and synovial fluid aspiration

Within 10 days post-injury

1 visit (in-person)

Follow-up

Participants are monitored for changes in cytokine and matrix metalloproteinase levels

1 to 2 weeks post-injury

2 visits (in-person)

Treatment Details

Interventions

• Saline Lavage

Trial Overview The study tests if washing out the ankle joint with saline soon after an intra-articular fracture can reduce inflammation and prevent cartilage damage compared to patients who don't get this early lavage before their surgery.

Participant Groups

Group I: Intra-articular saline lavage Experimental Treatment 3 Interventions

Subjects in Group 1 will then undergo saline joint lavage as follows: Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.

Group II: No intra-articular saline lavage Active Control 4 Interventions

Subjects in group 2 will not undergo normal saline lavage.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

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]

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]

In a study of 142 patients with relapsing rheumatoid arthritis, arthroscopic lavage using 5 liters or 3 liters of saline significantly improved clinical outcomes compared to arthrocentesis, with no serious complications reported.

Patients with knee arthritis lasting more than 6 months and with mild joint damage (Larsen grade II or less) responded better to lavage, and the therapeutic effect was enhanced when combined with steroid and hyaluronan injections after using 3 liters of saline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volume of a wash and the other conditions for maximum therapeutic effect of arthroscopic lavage in rheumatoid knees. Tanaka, N., Sakahashi, H., Hirose, K., et al.[2018]

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 of 478 patients undergoing aseptic revision total knee and hip arthroplasties, using dilute betadine lavage significantly reduced the rate of acute postoperative periprosthetic joint infections (PJI) compared to normal saline, with infections occurring in 0.4% of the betadine group versus 3.4% in the saline group.

The study found no significant difference in wound complications between the two groups, indicating that dilute betadine lavage is a safe and effective method to lower infection rates without increasing other surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dilute Betadine Lavage Reduces the Risk of Acute Postoperative Periprosthetic Joint Infection in Aseptic Revision Total Knee and Hip Arthroplasty: A Randomized Controlled Trial. Calkins, TE., Culvern, C., Nam, D., et al.[2020]

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]

In a study involving 53 patients with generalized peritonitis, different antiseptic solutions (chlorhexidine-gluconate and povidone-iodine) were compared to normal saline for their effectiveness in preventing complications after surgery.

The results showed that the type of lavage used did not significantly affect postoperative outcomes such as fever, wound infections, or length of hospital stay, indicating that the antiseptic solutions did not provide additional benefits over normal saline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiseptic vs. saline lavage in purulent and faecal peritonitis. Vallance, S., Waldron, R.[2019]

The study found that using a combination of saline and high-pressure carbon dioxide (CO2) lavage is significantly more effective at removing marrow elements from osteochondral allografts compared to standard saline lavage alone, with a notable reduction in remaining marrow elements in deeper layers.

In a controlled experiment involving six fresh hemicondyles and three treatment groups, the combination lavage technique achieved a 58.5% reduction in marrow elements in the deepest zone, compared to only 29.7% with saline lavage, highlighting its superior efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Lavage Techniques in Removing Immunogenic Elements from Osteochondral Allografts. Meyer, MA., McCarthy, MA., Gitelis, ME., et al.[2019]

References

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

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

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

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

3. 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]

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

Volume of a wash and the other conditions for maximum therapeutic effect of arthroscopic lavage in rheumatoid knees. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

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

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

Dilute Betadine Lavage Reduces the Risk of Acute Postoperative Periprosthetic Joint Infection in Aseptic Revision Total Knee and Hip Arthroplasty: A Randomized Controlled Trial. [2020]

7. 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]

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

Antiseptic vs. saline lavage in purulent and faecal peritonitis. [2019]

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

Effectiveness of Lavage Techniques in Removing Immunogenic Elements from Osteochondral Allografts. [2019]