Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-04 @ 2:55 PM
Study NCT ID:
NCT01923805
Status:
TERMINATED
Last Update Posted:
2017-06-07
First Post:
2013-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitagel Revision Total Knee Arthroplasty
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
A Prospective Randomized Evaluation of a Collagen/Thrombin Autologous Platelet Hemostatic Agent During Revision Knee Arthroplasty
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty enrolling patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's change in hemoglobin/hematocrit. Transfusion rates with the use of VG compared to the current standard of care will also be evaluated. The effectiveness of VG to potentially reduce pain, and increase return to function and quality of life will be assessed through the modified Knee Injury and Osteoarthritis Outcome Score (Modified KOOS), the Numerical Assessment Pain Scale (NAPS), and the SF-12 health survey. Analgesic use will be recorded post-operatively.
Detailed Description:
This is a prospective, randomized, blinded clinical trial involving 4 orthopedic surgeons who perform Revision Total Knee Arthroplasty (RTKA), including Trevor Murray (PI), Viktor Krebs, Robert Molloy, and Carlos Higuera. A total of eighty subjects scheduled for RTKA, who meet all inclusion criteria and exhibit none of the exclusion criteria will be invited to participate in the study. Only subjects who sign the Institutional Review Board-approved Informed Consent Form will be entered into the Study.
In the forty treatment Subjects, VG will be applied to each surgical site. The forty control subjects will receive the surgeon's standard of care, without the use of any other hemostatic agents. The subjects will not be informed of their assignment, and the research investigator making the determination on blood transfusion requirements for all study subjects will also be blinded to the subject assigned arm of the study. The research investigator performing RTKA will remain blinded to the study arm until the randomization envelope is opened, which will take place during surgery, after hemostasis is achieved using bovie electrocautery, and prior to closure of the knee capsule.
Assessments will be made per the Time and Events Schedule.
Subjects will be evaluated for intra- and post-operative complications, and all such events, should they occur, will be recorded during the course of the study. Details describing the event, cause of event, its treatment and resolution will be documented.
In the forty treatment Subjects, VG will be applied to each surgical site. The forty control subjects will receive the surgeon's standard of care, without the use of any other hemostatic agents. The subjects will not be informed of their assignment, and the research investigator making the determination on blood transfusion requirements for all study subjects will also be blinded to the subject assigned arm of the study. The research investigator performing RTKA will remain blinded to the study arm until the randomization envelope is opened, which will take place during surgery, after hemostasis is achieved using bovie electrocautery, and prior to closure of the knee capsule.
Assessments will be made per the Time and Events Schedule.
Subjects will be evaluated for intra- and post-operative complications, and all such events, should they occur, will be recorded during the course of the study. Details describing the event, cause of event, its treatment and resolution will be documented.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: