Infection
Conditions
Keywords
TKA, Vancomycin
Brief summary
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.
Detailed description
Infection after surgery is one of the most common complication after total knee replacement. Our prospective randomized study is intended to show if addition of vancomycin to the joint before the wound closure will decrease infection after operation.
Interventions
PROCEDUREKnee arthroplasty
total or unilateral knee arthroplasty
Sponsors
Centre of Postgraduate Medical Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Gosnartrosis
Exclusion criteria
* no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb ASA score \> II
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical site infection | up to 24 months | The incidence of deep and superficial SSI after knee arthroplasty |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood test - IL 6 | 12 weeks, | inflammatory reaction - Il-6 |
| Functional tests | 12 weeks, | hop-for-distance |
| Knee injury and Osteoarthritis Outcome Score | 6 weeks | Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4). |
| Blood test - CRP | 12 weeks, | inflammatory reaction - CRP |
| Visual analog Scale | 6 weeks | Pain Visual Analog Scale The pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)\[8\] orientated from the left (worst) to the right (best). |
| Tegner Lysholm Knee Scoring Scale | 6 weeks | The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). |
| 36-Item Short Form Survey | 6 weeks | Quality of life, pain SF-36 |
Countries
Poland
Contacts
Primary ContactRafal Kaminski, MD PhD
Outcome results
None listed