Surgical Irrigation for Knee or Hip Arthritis

(XPERIENCE Trial)

Recruiting at 8 trial locations

Overseen By Sophie Henke Tarnow

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

Trial Summary

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.

What data supports the effectiveness of the treatment for knee or hip arthritis?

Research shows that using dilute povidone-iodine (Betadine) irrigation during surgery can reduce the risk of infection after hip and knee replacements. This treatment has been found to lower bacterial counts in surgical sites, which may help prevent infections. ^{1 2 3 4 5}

Is surgical irrigation with povidone-iodine safe for humans?

Povidone-iodine (Betadine) is generally used to reduce infection risk in surgeries, but there are safety concerns. It has been associated with hypothyroidism (low thyroid function) and kidney issues, and in rare cases, fatal iodine toxicity has been reported. ^{1 3 6 7 8}

How is the treatment of dilute Betadine and XPERIENCE Advanced Surgical Irrigation unique for knee or hip arthritis?

This treatment is unique because it uses dilute Betadine (povidone-iodine) irrigation during surgery to reduce the risk of infection, which is a common complication in joint surgeries. It is a simple, cost-effective method that can be easily implemented to help prevent infections after knee or hip replacement surgeries. ^{1 2 3 5 9}

What is the purpose of this trial?

A prospective, multi-center, double-arm, parallel, interventional, randomized, controlled clinical trial to assess the rate of periprosthetic joint infection (PJI) in patients undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA) or hip resurfacing (HR) with XPERIENCE™ (XP) Advanced Surgical Irrigation versus dilute Betadine (DB).

Research Team

Simon Garceau, MD

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Povidone-iodine irrigation reduces infection after total hip and knee arthroplasty. [2023]

2. Italy 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. [2021]

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

Dilute betadine lavage reduces implant-related bacterial burden in a rabbit knee prosthetic infection model. [2017]

4. United States 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. [2023]

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

Intraoperative povidone-iodine irrigation for infection prevention. [2020]

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

Povidone Iodine Disinfection Associated with Hypothyroidism and Potentially Contributing to Prolonged Kidney Failure. [2022]

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

Pilot Study to Evaluate the Adjunct Use of a Povidone-Iodine Topical Antiseptic in Patients with Soft Tissue Abscesses. [2019]

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

Fatal iodine toxicity following surgical debridement of a hip wound: case report. [2019]

9. United States 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. [2020]