Trial Outcomes & Findings for Vitagel Revision Total Knee Arthroplasty (NCT NCT01923805)
NCT ID: NCT01923805
Last Updated: 2017-06-07
Results Overview
The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.
Results posted on
2017-06-07
Participant Flow
Participant milestones
| Measure |
Treatment Group
Vitagel
Vitagel: Vitagel
|
Control
Standard of care for surgical hemostasis.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitagel Revision Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Treatment Group
n=3 Participants
Vitagel
Vitagel: Vitagel
|
Control
n=5 Participants
Standard of care for surgical hemostasis.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
57.8 years
n=7 Participants
|
60.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.Population: Data were not collected from participants enrolled in the study
The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA.
Outcome measures
| Measure |
Treatment Group
Vitagel
Vitagel: Vitagel
|
Control
Standard of care for surgical hemostasis.
|
|---|---|---|
|
Transfusion Requirements
|
0
|
0
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group
n=3 participants at risk
Vitagel
Vitagel: Vitagel
|
Control
n=5 participants at risk
Standard of care for surgical hemostasis.
|
|---|---|---|
|
Blood and lymphatic system disorders
Pulmonary Embolism, bilateral lower extremity deep vein thrombosis
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Alison Klika; Research Program Manager, Adult Reconstruction
Cleveland Clinic
Phone: 216-444-4954
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place