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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called saline lavage to determine if it reduces inflammation and damage in ankle joints after a fracture. The goal is to discover whether washing out the joint with saline (a saltwater solution) within 48 hours of injury can lower harmful substances that cause swelling and cartilage damage. Two groups will participate: one will receive the saline lavage, and the other will not. Suitable candidates have an ankle fracture where the break reaches the joint surface and received treatment at Duke University Hospital within 48 hours of their injury. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatment options for ankle fractures.

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 this saline lavage technique is safe for ankle fractures?

Research has shown that using saline solution to wash out areas during medical procedures is generally safe. Studies describe it as a simple, low-risk, and affordable method. Although not specifically tested for ankle fractures, its use in similar situations suggests it is well-tolerated. Rare risks, such as air bubbles entering the bloodstream, exist but are uncommon. Overall, saline solution remains a safe option with few side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the traditional methods for treating ankle fractures that often involve rest, immobilization, and sometimes surgery, saline lavage offers a unique approach by directly cleansing the ankle joint. This technique involves flushing the joint with sterile saline, potentially reducing inflammation and promoting quicker healing. Researchers are excited about this method because it could minimize swelling and pain more effectively and might enhance recovery time compared to standard care options. By directly targeting the joint environment, saline lavage may offer a more immediate and localized treatment, which could be a game-changer for those with ankle fractures.

What evidence suggests that saline lavage is effective for ankle fracture?

Research shows that washing out the ankle joint with a saltwater solution soon after a fracture might help reduce swelling and pain. This trial will compare two groups: one group will receive intra-articular saline lavage, which clears out substances that cause inflammation. Studies have found that this method can lower the levels of certain proteins that trigger more inflammation. By removing these proteins, the saltwater wash might help protect the joint from further harm. Although direct evidence for ankle fractures is limited, similar techniques have successfully reduced inflammation in other joint injuries. The other group in this trial will not receive the saline lavage, serving as a comparator. ^{1 2 4 6 7}

Who Is on the Research Team?

Samuel Adams, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

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

Must be treated at Duke University Hospital Emergency Department

I got injured within the last 48 hours.

I have a broken ankle bone that extends into the joint.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05465382

Study Details | NCT05465382 | Intra Articular Ankle Fractures The purpose of this study is to examine the effect of early, percutaneous, intra-articular saline lavage on the undiluted synovial fluid microenvironment ...

2. withpower.com withpower.com/trial/phase-intra-articular-fractures-6-2022-863a5?fbclid=IwZXh0bgNhZW0CMTEAAR4umnMvH7sIaDJr2pT3XWlZAkwImMhQxvDFix8Q6BCWeH_NPgjigQ5-SqDnTQ_aem_A1oeK8bwWK8I9zPI0M0f2w

Saline Lavage for Ankle Fracture · Info for Participants The purpose of this study is to examine the effect of early, percutaneous, intra-articular saline lavage on the undiluted synovial fluid microenvironment ...

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

Joint Lavage for Ankle Fractures 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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23490316/

Evaluation of saline load test for simulated traumatic ... Based on these results, a minimum infusion of 30 cm(3) is recommended to identify 95% of traumatic arthrotomies approximately 4mm in size.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1508502

A Trial of Wound Irrigation in the Initial Management ... We investigated the effects of castile soap versus normal saline irrigation delivered by means of high, low, or very low irrigation pressure.

6. trialx.com trialx.com/clinical-trials/listings/268647/intra-articular-ankle-fractures/

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2259344/

Fluid lavage in patients with open fracture wounds (FLOW) The results of this survey demonstrated four key findings: 1) Most surgeons preferred the use of normal saline alone when irrigating open fracture wounds, 2) ...