Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01175044 |
| Other study ID # |
10031106 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 2010 |
| Est. completion date |
July 8, 2019 |
Study information
| Verified date |
August 2021 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to examine the efficacy of a dilute betadine solution in
reducing infectious complications in revision total knee arthroplasty. The investigators will
enroll patients who are scheduled to undergo a revision total knee arthroplasty. Patients
will be randomized into two groups. The treatment group will receive a dilute betadine lavage
prior to surgical closure for 3 minutes followed by 2000ml of sterile saline irrigation and
the control group will receive the 2000ml sterile saline lavage alone.
Description:
Infections in total knee arthroplasty are still a major source of morbidity and mortality in
Orthopaedics. They often necessitate long term antibiotics, reoperation, and can lead to
further complications such as sepsis or even death. Infection prevention remains one of the
primary goals of an orthopedic surgeon. While most sources report the infection rate for
primary total knee arthroplasty to be less than 1%, the reported rate for infection in
revision total knee arthroplasties has been reported to be as high as 5.6%. Despite steps
taken towards infection prevention such as proper administration of preoperative antibiotics,
strict adherence to sterile methods, and meticulous sterile preparation of the surgical site;
infection remains higher in the total knee revision arthroplasty patient population when
compared to primary total knee arthroplasty. A dilute betadine lavage (0.35% to 1% povidone
iodine) prior to surgical closure has been shown in general surgical procedures as well as
orthopaedic spine surgeries to reduce the infection rate in their patients, but this has not
been examined in total joint arthroplasty.
The study will enroll patients who are scheduled to undergo a revision total knee
arthroplasty. Patients will be randomized into two groups. The treatment group will receive a
dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000ml of sterile
saline irrigation and the control group will receive the 2000ml sterile saline lavage alone.
All other treatment will be standard of care.
Subjects will then be followed for one year post surgery for infection, as defined by
Appendix 1, at intervals of 2 weeks, 6 weeks, 3 months, and one year from the date of
surgery. During these visits patients will receive standard post operative care which
includes infection screening. If an infection is clinically suspected with symptoms such as
warmth and erythema over the joint, reduced mobility of the joint, and increasing pain at the
joint, then infection data will be collected which will consist of a Erythrocyte
Sedimentation Rate, C-Reactive Protein levels and a synovial fluid sample will be taken for
white blood cell count and bacterial culture.
