Surgical Irrigation for Knee or Hip Arthritis

(XPERIENCE Trial)

Recruiting at 11 trial locations

Overseen By Sanjula Costa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Immunomodulatory, Glucocorticosteroids

Disqualifiers: Active infection, Immunodeficiency, Transplantation, others

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

Compensation: Varies

Number of Visits: 3

Duration: Surgery day

7600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how two different surgical washes reduce infections after knee or hip replacement surgery. One group will use a solution called XPERIENCE Advanced Surgical Irrigation, while the other will use a dilute Betadine solution, an antiseptic. The goal is to identify which wash better prevents infections around the new joint. Individuals diagnosed with arthritis or joint issues and planning their first total knee or hip replacement may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to important research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on certain immunosuppressive drugs or chronic high-dose steroids. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that XPERIENCE Advanced Surgical Irrigation is safe. Reports indicated no irritation, and it protected against bacteria for several hours. Another study found no infections within 90 days after knee or hip replacement surgery.

Research shows that Dilute Betadine is safe and effective, significantly reducing infection rates compared to no irrigation. Other studies found it equally safe in different strengths, with no increase in the need for additional surgeries.

Both treatments have demonstrated good safety results in past research, suggesting they are well-tolerated by patients undergoing joint surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for knee or hip arthritis, which typically involve anti-inflammatory medications or physical therapy, the trial is exploring surgical irrigation techniques. XPERIENCE Advanced Surgical Irrigation is unique because it utilizes a specialized irrigation system that might better clean and protect the surgical site before wound closure. Researchers are excited about this approach because it could enhance recovery and reduce infection rates compared to conventional methods like using dilute Betadine solution. By focusing on improving surgical outcomes, this method could offer a new way to enhance healing and patient comfort after surgery.

What evidence suggests that this trial's treatments could be effective for preventing periprosthetic joint infection?

This trial will compare the effectiveness of XPERIENCE Advanced Surgical Irrigation and Dilute Betadine in preventing infections after knee and hip surgeries. Studies have shown that XPERIENCE Advanced Surgical Irrigation effectively reduces infections post-surgery, with one study reporting no joint infections within 90 days of use. Similarly, research has indicated that dilute Betadine lowers infection rates, cutting the risk of joint infections by more than half. Both treatments have demonstrated promising results in preventing infections after knee and hip surgeries. ^{4 5 6 7 8}

Who Is on the Research Team?

Simon Garceau, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with knee or hip arthritis, osteoarthritis, osteonecrosis, or post-traumatic arthritis who need a total knee or hip replacement or hip resurfacing. Participants must be able to follow the study plan and attend all follow-ups.

Inclusion Criteria

Willing and able to sign written consent, follow study protocol and attend follow-up

Subjects receiving both cemented or uncemented orthopaedic implants

I have been diagnosed with a joint condition such as osteoarthritis or similar.

Exclusion Criteria

I had an infection in my joint within the last two years.

Inability or refusal to sign informed consent form

Allergy to any of the components of XP Advanced Surgical Irrigation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary total knee arthroplasty, total hip arthroplasty, or hip resurfacing with either XPERIENCE Advanced Surgical Irrigation or dilute Betadine prior to wound closure

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for periprosthetic joint infection and other outcomes

12 months

Multiple visits (in-person) at 2 weeks, 3 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Dilute Betadine
• XPERIENCE Advanced Surgical Irrigation

Trial Overview

The trial compares XPERIENCE Advanced Surgical Irrigation against dilute Betadine in preventing joint infections after primary total knee arthroplasty (TKA), total hip arthroplasty (THA), or hip resurfacing (HR). It's randomized and controlled to ensure fair results.

How Is the Trial Designed?

Group I: XPERIENCE Advanced Surgical Irrigation Experimental Treatment 1 Intervention

Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.

Group II: Dilute Betadine Active Control 1 Intervention

Patients will receive Dilute Betadine solution prior to wound closure.

Dilute Betadine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Betadine for:

• Topical disinfection
• Surgical site infections prevention

Approved in European Union as Povidone iodine for:

• Topical disinfection
• Surgical site infections prevention

Approved in Canada as PVP-I for:

• Topical disinfection
• Surgical site infections prevention

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Next Science TM

Industry Sponsor

Trials

17

Recruited

9,700+

Published Research Related to This Trial

In a study of 5,534 total hip arthroplasties (THA) and 6,204 total knee arthroplasties (TKA), the use of dilute povidone-iodine (PI) irrigation prior to wound closure did not significantly reduce the rate of reoperation for infection at 3 months or 1 year for THA.

For TKA, while there was a higher rate of reoperations for infection at 1 year in patients who received PI irrigation (1.2%) compared to those who did not (0.6%), this difference was not significant after adjusting for baseline characteristics, indicating that PI irrigation may not be beneficial in preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Povidone-Iodine Irrigation Prior to Wound Closure in Primary Total Hip and Knee Arthroplasty: An Analysis of 11,738 Cases. Hernandez, NM., Hart, A., Taunton, MJ., et al.[2020]

In a randomized controlled pilot study of adult patients with superficial skin abscesses, the addition of povidone-iodine (PVP-I) to standard incision and drainage (I&D) treatment did not significantly improve clinical cure rates, with 88.2% in the PVP-I group compared to 91.3% in the standard care group.

However, the PVP-I group experienced a significantly higher rate of adverse events (59.6%) compared to the standard care group (26.5%), primarily due to local skin irritation, indicating that while PVP-I may not enhance efficacy, it may increase the risk of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study to Evaluate the Adjunct Use of a Povidone-Iodine Topical Antiseptic in Patients with Soft Tissue Abscesses. Olson, AS., Rosenblatt, L., Salerno, N., et al.[2019]

In a study involving 941 patients undergoing gastroenterological surgery, intraoperative wound irrigation (IOWI) with aqueous povidone-iodine (PVP-I) did not significantly reduce the incidence of surgical site infections (SSI) compared to saline, with SSI rates of 7.6% for PVP-I and 5.1% for saline.

The results suggest that the current recommendation for using IOWI with PVP-I for preventing SSIs may need to be reevaluated, as the difference in infection rates was not statistically significant (P = 0.154).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aqueous Povidone-Iodine Versus Normal Saline For Intraoperative Wound Irrigation on The Incidence of Surgical Site Infection in Clean-Contaminated Wounds After Gastroenterological Surgery: A Single-Institute, Prospective, Blinded-Endpoint, Randomized Controlled Trial. Maemoto, R., Noda, H., Ichida, K., et al.[2023]

In a study of 3232 patients undergoing total hip or knee arthroplasty, the use of dilute Betadine irrigation prior to wound closure significantly reduced the overall infection rate and the rate of surgical site infections (SSI) compared to normal saline, with odds ratios of 0.45 and 0.30 respectively.

While Betadine irrigation was effective in reducing general infections and SSIs, it did not show a significant impact on deep infections, indicating that while it is a beneficial practice, it may not eliminate all risks associated with periprosthetic joint infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone-iodine irrigation reduces infection after total hip and knee arthroplasty. Muwanis, M., Barimani, B., Luo, L., et al.[2023]

Using a dilute povidone-iodine solution for intraoperative irrigation during arthroplasty is recommended by major health organizations and is considered safe and cost-effective.

The article outlines an institutional protocol for irrigation and reviews existing literature, supporting the effectiveness of this practice in preventing infections post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative povidone-iodine irrigation for infection prevention. Goswami, K., Austin, MS.[2020]

In a study involving 16 rabbit knees infected with Staphylococcus aureus, using a 3.5% Betadine lavage significantly reduced bacterial counts on the stainless steel screw and polyethylene washer after polyethylene exchange treatment.

The results suggest that Betadine lavage could be a beneficial adjunct treatment to improve the retention of components in cases of acute postoperative arthroplasty infection, although it did not affect bacterial growth in soft tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dilute betadine lavage reduces implant-related bacterial burden in a rabbit knee prosthetic infection model. Gilotra, M., Nguyen, T., Jaffe, D., et al.[2017]

A case report of a 13-year-old patient revealed that daily disinfection of fasciotomy wounds with povidone-iodine (PVP-I) may have led to iodide absorption, contributing to hypothyroidism and prolonged kidney injury after severe abdominal sepsis.

After stopping PVP-I exposure and starting thyroid hormone treatment, the patient's kidney function improved, suggesting that PVP-I toxicity and/or hypothyroidism could have played a role in the persistent renal failure, highlighting the need for careful monitoring of PVP-I use in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone Iodine Disinfection Associated with Hypothyroidism and Potentially Contributing to Prolonged Kidney Failure. Vercammen, Y., Dauwe, D., De Vlieger, G., et al.[2022]

A patient died 10 hours after hip-wound debridement due to systemic absorption of iodine from Betadine, which was used for continuous postoperative wound irrigation.

This case highlights the potential toxicity of povidone iodine solutions when absorbed systemically, emphasizing the need for careful monitoring and consideration of alternatives in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatal iodine toxicity following surgical debridement of a hip wound: case report. D'Auria, J., Lipson, S., Garfield, JM.[2019]

A systematic review of six studies on the use of dilute povidone-iodine (DPI) irrigation in total joint arthroplasty showed mixed results regarding its effectiveness in reducing periprosthetic joint infections (PJI).

While some studies indicated that DPI irrigation may lower the risk of surgical site infections, others found no significant difference, highlighting the need for further research to clarify its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diluted povidone-iodine irrigation prior to wound closure in primary and revision total joint arthroplasty of hip and knee: a review of the evidence. Cacciola, G., Mancino, F., Malahias, MA., et al.[2021]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0883540313001897

Deleterious Effects of Diluted Povidone–Iodine on Articular ...

Our data suggest that povidone–iodine solution at all tested concentrations has a pronounced chondrotoxic effect on the superficial cartilage layer when used ...

2.

withpower.com

withpower.com/trial/phase-arthritis-2023-48ec5

Surgical Irrigation for Knee or Hip Arthritis (XPERIENCE Trial)

Research shows that using dilute povidone-iodine (Betadine) irrigation during surgery can reduce the risk of infection after hip and knee replacements. This ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34742876/

Dilute Povidone-Iodine Irrigation Reduces the Rate of ...

Results: In total, 340 patients (1.09%) developed PJI. Dilute povidone-iodine irrigation was associated with 2.34 times lower rate of PJI (0.6% vs 1.3%). Using ...

4.

raaot.org.ar

raaot.org.ar/index.php/AAOTMAG/article/download/1530/4920/

Diluted Povidone-Iodine Lavage in Total Hip and Knee ...

Data were recorded by a fellow trained in reconstructive orthopedic surgery of the lower limb. Postoperative controls were performed at 3 and 6 weeks, and at 3 ...

5.

arthroplastyjournal.org

arthroplastyjournal.org/article/S0883-5403(13)00189-7/abstract

Deleterious Effects of Diluted Povidone–Iodine on Articular ...

A recent study has suggested that irrigation with povidone–iodine solution after knee arthroplasty significantly decreases rates of post-operative surgical ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10909383/

Non-inferiority and Safety of Increased Povidone-Iodine ...

This study demonstrated no difference in rates of all-cause revision or PJI when using 0.3% Betadine versus 0.54% Betadine for irrigation following pTJA.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0883540321008317

Primary Hip and Knee Arthroplasty Dilute Povidone-Iodine ...

Dilute povidone-iodine irrigation was associated with 2.34 times lower rate of PJI (0.6% vs 1.3%). Using multiple regression, dilute povidone-iodine remained ...

8.

bmcmusculoskeletdisord.biomedcentral.com

bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-06548-x

How effective is diluted povidone-iodine in preventing ...

concluded that diluted PI lavage is a safe and beneficial approach to lower the incidence of acute postoperative PJI, compared with NS [8].