A Phase 4 interventional study of Evicel fibrin sealant in Osteoarthritis, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-10-29.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Prevention
Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.
No additional data desired
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 200 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
Drug: Evicel fibrin sealant
Patients will receive standard treatment for bleeding as practiced at the Hospital for Special Surgery.
Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.
Change in Hemoglobin on Day 0 Compared to Preoperatively
Time frame: preoperatively and on the day of surgery
Change in Hematocrit on Day 0 Compared to Preoperatively
Time frame: preoperatively and day of surgery
Change in Hemoglobin On Day 1 Compared to Preoperatively
Time frame: preoperatively and one day after surgery
Change in Hematocrit on Day 1 Compared to Preoperatively
Time frame: preoperatively and one day after surgery
Change in Hemoglobin on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Change in Hematocrit on Day 2 Compared to Preoperatively
Time frame: preoperatively and two days after surgery
Drain Output
A measurement of the amount of blood drained from the knee.
Time frame: 24 hours post-operatively
Number of Autologous Transfusion Units Over the Course of the Hospital Stay
Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Time frame: perioperatively
Units of Homologous Transfusion Over the Course of the Hospital Stay
Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Time frame: three days postoperatively
Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively
The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time.
Time frame: preoperatively and two days after surgery
Range of Motion on Day 3
A measurement of the degrees of motion of the operated knee three days after surgery.
Time frame: 3 days postoperatively
Visual Analog Pain Scale on Day 3
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale.
Time frame: 3 days postoperatively
Range of Motion at 6 Weeks
A measurement of the degrees of motion of the operated knee six weeks after surgery.
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (at Rest) at 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving.
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (During Activity) at 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing.
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (During Therapy) at 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy.
Time frame: 6 weeks postoperatively
Visual Analog Pain Scale (At Night) At 6 Weeks
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep.
Time frame: 6 weeks postoperatively
Patients undergoing total knee arthroplasty at the Hospital for Special Surgery from September 2010 to June 2012 were enrolled in a consecutive prospective manner on a voluntary basis.
| Milestone | Evicel | No Evicel |
|---|---|---|
| Started | 98 | 102 |
| Completed | 98 | 100 |
| Not completed | 0 | 2 |
| Withdrew: Physician decision | 0 | 2 |
| g/dL | Evicel | No Evicel |
|---|---|---|
| Change in Hemoglobin on Day 0 Compared to Preoperatively | -1.548 ± .745 | -1.458 ± .815 |
The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time.
| ratio | Evicel | No Evicel |
|---|---|---|
| Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively | .363 ± .421 | 0.309 ± 0.514 |
A measurement of the degrees of motion of the operated knee three days after surgery.
| degrees | Evicel | no Evicel |
|---|---|---|
| Range of Motion on Day 3 | 112.4 ± 1.983 | 114.1 ± 1.983 |
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale.
| points on VAS scale | Evicel | no Evicel |
|---|---|---|
| Visual Analog Pain Scale on Day 3 | 4.3 ± 1.983 | 3.9 ± 1.983 |
| percentage of red blood cell | Evicel | No Evicel |
|---|---|---|
| Change in Hematocrit on Day 0 Compared to Preoperatively | -4.639 ± 2.275 | -4.220 ± 2.537 |
| g/dL | Evicel | No Evicel |
|---|---|---|
| Change in Hemoglobin On Day 1 Compared to Preoperatively | -2.607 ± 0.986 | -2.480 ± 1.063 |
| percentage of red blood cell | Evicel | No Evicel |
|---|---|---|
| Change in Hematocrit on Day 1 Compared to Preoperatively | -7.382 ± 2.801 | -7.199 ± 3.381 |
| g/dL | Evicel | No Evicel |
|---|---|---|
| Change in Hemoglobin on Day 2 Compared to Preoperatively | -3.419 ± 1.437 | -3.497 ± 1.157 |
| percentage of red blood cell | Evicel | No Evicel |
|---|---|---|
| Change in Hematocrit on Day 2 Compared to Preoperatively | -9.676 ± 4.540 | -10.100 ± 3.597 |
A measurement of the amount of blood drained from the knee.
| mL | Evicel | no Evicel |
|---|---|---|
| Drain Output | 780 ± 54.23 | 673 ± 54.23 |
Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
| units | Evicel | no Evicel |
|---|---|---|
| Number of Autologous Transfusion Units Over the Course of the Hospital Stay | 0.38 ± 0.041 | 0.46 ± 0.041 |
Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
| units | Evicel | No Evicel |
|---|---|---|
| Units of Homologous Transfusion Over the Course of the Hospital Stay | 0.276 ± 0.729 | 0.228 ± 0.581 |
A measurement of the degrees of motion of the operated knee six weeks after surgery.
| degrees | Evicel | no Evicel |
|---|---|---|
| Range of Motion at 6 Weeks | 114 ± 10.8 | 115 ± 12.4 |
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving.
| units on a scale | Evicel | no Evicel |
|---|---|---|
| Visual Analog Pain Scale (at Rest) at 6 Weeks | 1.326 ± 1.362 | 1.615 ± 1.801 |
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing.
| units on a scale | Evicel | no Evicel |
|---|---|---|
| Visual Analog Pain Scale (During Activity) at 6 Weeks | 2.821 ± 1.972 | 3.25 ± 2.167 |
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy.
| units on a scale | Evicel | no Evicel |
|---|---|---|
| Visual Analog Pain Scale (During Therapy) at 6 Weeks | 4.479 ± 2.389 | 4.62 ± 2.597 |
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep.
| units on a scale | Evicel | No Evicel |
|---|---|---|
| Visual Analog Pain Scale (At Night) At 6 Weeks | 2.898 ± 2.192 | 2.813 ± 2.340 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Evicel | — | 0/98 (0%) | 28/98 (28.6%) |
| no Evicel | — | 0/102 (0%) | 17/102 (16.7%) |
| Event | Evicel | no Evicel |
|---|---|---|
| Cardiac or Blood Pressure IssuesCardiac disorders | 12/98 | 8/102 |
| GI Related ProblemsGastrointestinal disorders | 5/98 | 4/102 |
| FeverGeneral disorders | 4/98 | 3/102 |
| ConfusionGeneral disorders | 4/98 | 1/102 |
| Wound Healing ProblemSkin and subcutaneous tissue disorders | 2/98 | 0/102 |
| Urinary Tract InfectionsRenal and urinary disorders | 1/98 | 1/102 |
| Age, Categorical(Participants) | Evicel | no Evicel | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 41 | 75 |
| >=65 years | 64 | 61 | 125 |
| Age Continuous(years) | Evicel | no Evicel | Total |
|---|---|---|---|
| Mean | 68.12 ± 9.88 | 66.38 ± 8.47 | 67 ± 10 |
| Sex: Female, Male(Participants) | Evicel | no Evicel | Total |
|---|---|---|---|
| Female | 57 | 59 | 116 |
| Male | 41 | 43 | 84 |
| Region of Enrollment(participants) | Evicel | no Evicel | Total |
|---|---|---|---|
| United States | 98 | 102 | 200 |
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Hospital for Special Surgery, New York