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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.
This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment.
Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.
As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemostatic Matrix | Experimental | 2 vials of Floseal applied once at the end of surgery |
|
| Control | No Intervention | No intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemostatic Matrix | Drug | FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin on Day 0 Compared to Preoperatively | preoperatively and on the day of surgery | |
| Change in Hemoglobin on Day 0 Compared to Preoperatively | preoperatively and day of surgery | |
| Change in Hemoglobin On Day 1 Compared to Preoperatively | preoperatively and one day after surgery | |
| Change in Hematocrit on Day 1 Compared to Preoperatively | preoperatively and 1 day after surgery | |
| Change in Hemoglobin on Day 2 Compared to Preoperatively | preoperatively and two days after surgery | |
| Change in Hematocrit on Day 2 Compared to Preoperatively | preoperatively and two days after surgery | |
| Drain Output | 24 hours postoperatively | |
| Autologous Amount of Transfusion | three days postoperatively | |
| Homologous Amount of Transfusion | three days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion on Day 3 | 3days postoperatively | |
| Visual Analog Pain Scale on Day 3 | A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark P Figgie, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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Inclusion Criteria:
1)Diagnosis of knee arthritis in patients medically suitable to undergo unilateral TKA.
Pre-operative Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Hemostatic Matrix | 2 vials of Floseal applied once at the end of surgery |
| FG001 | Control | No intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hemostatic Matrix | 2 vials of Floseal applied once at the end of surgery |
| BG001 | Control | No intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hemoglobin on Day 0 Compared to Preoperatively | All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons | Posted | Mean | Standard Deviation | g/dL | preoperatively and on the day of surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemostatic Matrix | 2 vials of Floseal applied once at the end of surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark P. Figgie MD | Hospital for Special Surgery | 212-606-1932 | figgiem@hss.edu |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C411004 | FloSeal Matrix |
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|
|
| 3 days postoperatively |
| Range of Motion at Six Weeks | 6 weeks postoperatively |
| Visual Analog Pain Scale at 6 Weeks | A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. | 6 weeks postoperatively |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Change in Hemoglobin on Day 0 Compared to Preoperatively | All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis. | Posted | Mean | Standard Deviation | g/L | preoperatively and day of surgery |
|
|
|
| Primary | Change in Hemoglobin On Day 1 Compared to Preoperatively | All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons | Posted | Mean | Standard Deviation | g/dL | preoperatively and one day after surgery |
|
|
|
| Secondary | Range of Motion on Day 3 | Patients whose range of motion at 3 day followup appointment was taken were included in analysis. | Posted | Mean | Standard Deviation | degrees | 3days postoperatively |
|
|
|
| Secondary | Visual Analog Pain Scale on Day 3 | A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. | All patients whose pain score was collected were included in analysis. | Posted | Mean | Standard Deviation | points on visual analog pain scale | 3 days postoperatively |
|
|
|
| Primary | Change in Hematocrit on Day 1 Compared to Preoperatively | All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons | Posted | Mean | Standard Deviation | g/L | preoperatively and 1 day after surgery |
|
|
|
| Secondary | Range of Motion at Six Weeks | Patients whose range of motion at 6-week followup appointment was taken were included in analysis. | Posted | Mean | Standard Deviation | degrees | 6 weeks postoperatively |
|
|
|
| Primary | Change in Hemoglobin on Day 2 Compared to Preoperatively | All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons. | Posted | Mean | Standard Deviation | g/dL | preoperatively and two days after surgery |
|
|
|
| Primary | Change in Hematocrit on Day 2 Compared to Preoperatively | All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons | Posted | Mean | Standard Deviation | g/L | preoperatively and two days after surgery |
|
|
|
| Primary | Drain Output | Drain output at 24 hours was recorded for all patients. | Posted | Mean | Standard Deviation | mL | 24 hours postoperatively |
|
|
|
| Primary | Autologous Amount of Transfusion | Posted | Mean | Standard Deviation | units of blood | three days postoperatively |
|
|
|
| Primary | Homologous Amount of Transfusion | Posted | Mean | Standard Deviation | units of blood | three days postoperatively |
|
|
|
| Secondary | Visual Analog Pain Scale at 6 Weeks | A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured. The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity. | Patients whose pain level at 6-week followup appointment was taken were included in analysis. | Posted | Mean | Standard Deviation | points on visual analog pain scale | 6 weeks postoperatively |
|
|
|
| 0 |
| 97 |
| 5 |
| 97 |
| EG001 | Control | No intervention. | 0 | 99 | 6 | 99 |
| Deep Venous Thromboses | Vascular disorders | Non-systematic Assessment |
|
| Suture Abscess with Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Manipulation Under Anesthesia Needed to Achieve Improved Range of Motion | Surgical and medical procedures | Non-systematic Assessment |
|
| Paralytic Ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
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