Arthroplasty, Replacement, Knee
Conditions
Keywords
Drainage, Suction, tranexamic acid
Brief summary
Problem Suction drains during TKA present certain costs to the health system and requires additional nursing care. There is no clear evidence that supports their use, and no studies so far have compared blood loss in patients with or without drains when TA is administered during TKA. Hypothesis During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used. Method * Randomized controlled trial * Monocentric, 3 surgeons * Randomisation by sealed envelopes
Detailed description
During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.
Interventions
DEVICEdrainage
Administration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unilateral primary total knee arthroplasty
Exclusion criteria
* TKA revision * Bilateral TKA * Patients that refuse transfusions * Contraindication to tranexamic acid use: allergy, thromboembolic history * Coagulopathy * Kidney failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hb variation | 3 days after surgey | Difference between Hb levels measured in pre-op and on postoperatively day 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost of blood transfusions | from admission till 2 months after surgery | Cost of blood transfusions |
| Cost of suction drains | from admission till 2 months after surgery | Cost of suction drains |
| Range of motion of knee | preoperative visit , at the end of surgery, and on post-op day 3 | Range of motion of knee |
| Length of hospital stay | from admission till 2 months after surgery | Length of hospital stay |
| Number of blood transfusions | from admission till 2 months after surgery | Number of blood transfusions |
| Clinical results | from admission till 2 months after surgery | Major complications |
| KOOS score | At preoperative visit and post-operative visit of six weeks after surgery | Knee Injury and Osteoarthritis Outcome Score (KOOS); Scores are transformed to a 0-100 scale, 0: extreme knee problems, 100: no knee problems |
| SF-12 score | At preoperative visit and post-operative visit of six weeks after surgery | SF-12® Health Survey (SF-12); Physical and Mental Health Composite Scores (PCS & MCS) ; Minimum value: 0 (lowest level of health), Maximum value: 100 (highest level of health) |
| additional surgery | from admission till 2 months after surgery | possible causes for reoperation: hematoma drainage, infection, knee mobilization |
Countries
Canada
Outcome results
None listed