Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-market observational registry is to collect additional data on the safety and effectiveness of the HEMOBLAST™ Bellows device in total knee arthroplasty procedures.

Detailed Description
-----------------
A maximum of 100 subjects will be enrolled at up to 5 centers in the United States. Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 10 months from the time of first subject enrollment to completion of the last subject follow up.

Official Title
-----------------
Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty

Conditions
-----------------
Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Device: HEMOBLAST Bellows


Participation Criteria
=================
Eligibility Criteria
-----------------
Preoperative Inclusion Criteria: Patient is undergoing a unilateral total knee arthroplasty procedure; and Patient is willing and able to give written informed consent for registry participation. Preoperative Exclusion Criteria: Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and Patient has religious or other objections to porcine, bovine, or human components. Intraoperative Inclusion Criteria Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate bleeding for which conventional means for hemostasis are ineffective or impractical; and The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indication for Use.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total Knee Arthroplasty Patients<br>Patients undergoing primary or revision total knee arthroplasty procedures in which the surgeon elects to use HEMOBLAST Bellows to control minimal, mild, or moderate bleeding for which conventional means of hemostasis are ineffective or impractical | Device: HEMOBLAST Bellows<br>* The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of Hemostasis at the Target Bleeding Site | The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed | Intraoperatively, expected within 3-10 minutes of application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Device Effects (SADEs) | The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified | Through study completion, on average 1-2 days post-surgery | 
| Incidence of Unanticipated Serious Adverse Device Effects (UADEs) | The incidence of Serious Adverse Events that are both unanticipated and deemed by the investigator to be possibly, probably, or definitely related to the device | Through study completion, on average 1-2 days post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemostatics, Coagulants