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TKA: No effect of fibrin sealant on reducing blood loss and functional recovery
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June 2013
TKA: No effect of fibrin sealant on reducing blood loss and functional recovery
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A
No effect of fibrin sealant on drain output or functional recovery following simultaneous bilateral total knee arthroplasty
Acta Orthop. 2013 Apr;84(2):153-8. doi: 10.3109/17453674.2013.769082. Epub 2013 Jan 25Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
24 patients (48 knees) undergoing simultaneous bilateral total knee arthroplasty (TKA) had their knees 1:1 randomized to receive an intraoperative application of either fibrin sealant or saline. The purpose was to determine the adjuvant effect of fibrin sealant on postoperative blood loss in patients already treated with preoperative tranexamic acid and tourniquet use. Blood loss was calculated 24 hours following surgery, and patients were assessed for functional recovery up to 21 days postoperatively. The findings indicated that there was no decrease in blood loss in knees treated with fibrin sealant, and that pain, swelling, range of motion, and isokinetic strength was similar between knees, regardless of the application of fibrin sealant or saline.
Publication Funding Details
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Funding:
Industry funded
Sponsor:
Johnson and Johnson Medical Ltd.
Conflicts:
None disclosed
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Randomization
3/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Postoperative blood loss following total knee arthroplasty (TKA) may be associated with significant morbidity and impaired functional recovery. There have been many developments in stemming blood loss following surgery, one of which is a topical application of fibrin sealant. While the hemostatic agent has been investigated in prior studies, there is limited evidence of its effect as an adjunct to other blood loss regimens (ie. tranexamic acid, intramedullary femoral canal plugging), as well as its effect on functional recovery.
What was the principal research question?
What is the effect of adjuvant fibrin sealant on postoperative blood loss and early functional recovery following total knee arthroplasty, with blood loss measured within the first 24 postoperative hours and function assessed up to 21 days postoperatively?
Study Characteristics
-
Population:
24 patients (n=48 knees) undergoing simultaneous bilateral total knee arthroplasty. All patients were given preoperative cefuroxime (1.5g intravenously) and tranexamic acid (0.5g 10 min prior to tourniquet inflation (100mmHg above systolic pressure) on the first knee, followed by 0.5g after deflation and before inflation on the second knee), and were operated on with a medial parapatellar approach. Closure of the femoral canal was achieved with an autologous bone plug, and one intra-articular drain (passive) was installed in each knee. Patients either received AGC or Vanguard ROCC (Biomet) prostheses. (Mean age: 65 years)
Intervention:
Fibrin sealant group: After implantation of the knee prosthesis, and while the tourniquet was still inflated, 10mL of fibrin sealant (Evicel) was sprayed onto all instrumented cut surfaces and soft tissues. (n=24 knees)
Comparison:
Control group: After implantation of the knee prosthesis, and while the tourniquet was still inflated, 10mL of saline was sprayed onto all instrumented cut surfaces and soft tissues. (n=24 knees)
Outcomes:
Primary outcome was blood loss within the first 24h postoperatively, measured by drain output. Secondary outcomes included pain on a visual analog scale (VAS), knee swelling measured by knee circumference (1cm proximal to patella), knee range of motion (ROM) using a goniometer, and isometric knee strength.
Methods:
RCT, Double-blind, Placebo-controlled, Single-centre
Time:
Blood loss was measured at 24h postoperatively. Knee pain and swelling were assessed daily until postoperative day (POD) 3, then again at POD 7 and 21. ROM and strength assessment was conducted at POD 3, 7, and 21.
What were the important findings?
- Mean blood loss calculated from drains at 24h postoperatively was 582mL (SD 328mL) for knees allocated to the fibrin sealant and 576mL (SD 289mL) in knees treated with saline (p=0.9).
- There was no significant difference in pain between groups either at rest or during flexion at any time-point (all p>0.05).
- Knee swelling did not significantly differ between groups at any assessment (p>0.05).
- ROM assessment of both flexion and extension were observed to be similar between groups at each time point, with no significant differences being observed (all P>0.05).
- Isometric knee strength was similarly reduced from baseline at day 3 assessment in both groups, with gradual recovery. Recovery by day 21 was still lower that preoperative values. There were no significant differences between groups at any of the assessments (all P>0.05).
What should I remember most?
The use of the fibrin sealant, Evicel, in total knee arthroplasty did not reduce blood loss, nor promote any benefit in functional recovery when compared to placebo treatment with saline in the contralateral knee.
How will this affect the care of my patients?
The results of the present study do not support the application of adjuvant fibrin sealant as a means to stem postoperative blood loss following total knee arthroplasty. However, there was concern that hyperemia caused by the deflation of the tourniquet may have flushed out the fibrin sealant prior to eliciting any potential effect. It may be worthwhile to determine if there is an effect of Evicel in the absence of tourniquet use.
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