Arthroplasty, Replacement, Knee
Conditions
Keywords
Hemostatics, Coagulants
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.
Interventions
DEVICEHEMOBLAST Bellows
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.
Sponsors
Biom'Up France SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Hemostasis at the Target Bleeding Site | Intraoperatively, expected within 3-10 minutes of application | The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Device Effects (SADEs) | Through study completion, on average 1-2 days post-surgery | The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified |
| Incidence of Unanticipated Serious Adverse Device Effects (UADEs) | Through study completion, on average 1-2 days post-surgery | 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 |
Outcome results
None listed