Trial Outcomes & Findings for Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty (NCT NCT01027286)
NCT ID: NCT01027286
Last Updated: 2012-11-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
108 participants
Primary outcome timeframe
daily during hospital stay (an expected average of 4 days)
Results posted on
2012-11-29
Participant Flow
Participant milestones
| Measure |
Vitagel
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
Preoperative
|
50
|
50
|
|
Overall Study
Day of Surgery
|
50
|
50
|
|
Overall Study
4 Week Postoperative
|
49
|
50
|
|
Overall Study
12 Week Postoperative
|
49
|
49
|
|
Overall Study
COMPLETED
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Vitagel
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Overall Study
Unable to Obtain Required Blood Volume
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Vitagel
n=50 Participants
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
n=50 Participants
No Vitagel used during primary total knee arthroplasty
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
66.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: daily during hospital stay (an expected average of 4 days)Outcome measures
| Measure |
Vitagel
n=49 Participants
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
n=50 Participants
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Number of Patients Managed With Blood Transfusion
|
0 participants
|
5 participants
|
SECONDARY outcome
Timeframe: daily during hospital stay (an expected average of 4 days)Outcome measures
| Measure |
Vitagel
n=49 Participants
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
n=50 Participants
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Total Calculated Hospital Blood Loss
|
1577 mL
Standard Deviation 541
|
1620 mL
Standard Deviation 565
|
SECONDARY outcome
Timeframe: within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days)Outcome measures
| Measure |
Vitagel
n=49 Participants
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
n=50 Participants
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Preoperative & Postoperative Hemoglobin Values
Preoperative
|
13.8 g/dL
Standard Deviation 1.3
|
13.5 g/dL
Standard Deviation 1.4
|
|
Preoperative & Postoperative Hemoglobin Values
Post Anesthesia Care Unit
|
11.9 g/dL
Standard Deviation 1.3
|
11.8 g/dL
Standard Deviation 1.5
|
|
Preoperative & Postoperative Hemoglobin Values
Postoperative Day 1
|
10.5 g/dL
Standard Deviation 1.2
|
10.4 g/dL
Standard Deviation 1.5
|
|
Preoperative & Postoperative Hemoglobin Values
Postoperative Day 2
|
10.2 g/dL
Standard Deviation 1.2
|
9.7 g/dL
Standard Deviation 1.5
|
|
Preoperative & Postoperative Hemoglobin Values
Postoperative Day 3
|
9.9 g/dL
Standard Deviation 1.3
|
9.4 g/dL
Standard Deviation 1.2
|
|
Preoperative & Postoperative Hemoglobin Values
Postoperative Day 4
|
10.0 g/dL
Standard Deviation 1.0
|
8.8 g/dL
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: daily during hospital stay (an expected average of 4 days)Outcome measures
| Measure |
Vitagel
n=49 Participants
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
n=50 Participants
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Daily Narcotic Usage (Morphine-equivalent mg)
Postoperative Day 0
|
42.7 morphine-equivalent mg
Standard Deviation 35.0
|
50.5 morphine-equivalent mg
Standard Deviation 28.6
|
|
Daily Narcotic Usage (Morphine-equivalent mg)
Postoperative Day 1
|
69.1 morphine-equivalent mg
Standard Deviation 49.7
|
74.8 morphine-equivalent mg
Standard Deviation 56.1
|
|
Daily Narcotic Usage (Morphine-equivalent mg)
Postoperative Day 2
|
58.6 morphine-equivalent mg
Standard Deviation 47.2
|
65.4 morphine-equivalent mg
Standard Deviation 36.5
|
|
Daily Narcotic Usage (Morphine-equivalent mg)
Postoperative Day 3
|
39.8 morphine-equivalent mg
Standard Deviation 42.2
|
52.3 morphine-equivalent mg
Standard Deviation 45.9
|
|
Daily Narcotic Usage (Morphine-equivalent mg)
Postoperative Day 4
|
31.7 morphine-equivalent mg
Standard Deviation 43.2
|
45.8 morphine-equivalent mg
Standard Deviation 31.7
|
SECONDARY outcome
Timeframe: day of hospital dischargeOutcome measures
| Measure |
Vitagel
n=49 Participants
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
n=50 Participants
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Length of Stay
|
3.3 days
Standard Deviation 0.9
|
3.4 days
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgeryPopulation: Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)
A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing "no pain" and 10 representing "unbearable pain." Thus, in this context, lower values represent better outcomes.
Outcome measures
| Measure |
Vitagel
n=49 Participants
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
n=50 Participants
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Pain Score Scale
4 Weeks Postoperative
|
2.6 points on a scale
Standard Deviation 2.1
|
2.5 points on a scale
Standard Deviation 1.9
|
|
Pain Score Scale
Preoperative
|
5.5 points on a scale
Standard Deviation 2.5
|
6.0 points on a scale
Standard Deviation 2.4
|
|
Pain Score Scale
12 Weeks Postoperative
|
1.9 points on a scale
Standard Deviation 2.2
|
1.5 points on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgeryPopulation: Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)
A scoring system used to evaluate the patient's opinion about his/her knee and associated problems. Subscales include 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation (Sport/Rec), and 5) knee related quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score between 0 to 100 is calculated for each subscale. Subscale scores are generally not combined; rather, they are reported separated. Higher values represent better outcomes (i.e., less extreme symptoms).
Outcome measures
| Measure |
Vitagel
n=49 Participants
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
n=50 Participants
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Pain: Preoperative
|
43.5 points on a scale
Standard Deviation 17.0
|
39.9 points on a scale
Standard Deviation 16.8
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Pain: 4 Wks Postoperative
|
62.7 points on a scale
Standard Deviation 20.4
|
57.1 points on a scale
Standard Deviation 20.6
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Pain: 12 Wks Postoperative
|
76.6 points on a scale
Standard Deviation 18.8
|
75.5 points on a scale
Standard Deviation 14.6
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Symptoms: Preoperative
|
45.1 points on a scale
Standard Deviation 18.6
|
39.6 points on a scale
Standard Deviation 20.0
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Symptoms: 4 Wks Postoperative
|
61.9 points on a scale
Standard Deviation 19.6
|
58.4 points on a scale
Standard Deviation 16.8
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Symptoms: 12 Wks Postoperative
|
69.9 points on a scale
Standard Deviation 19.2
|
68.5 points on a scale
Standard Deviation 15.8
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Daily Living Activities: Preoperative
|
45.6 points on a scale
Standard Deviation 20.9
|
45.8 points on a scale
Standard Deviation 22.7
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Daily Living Activities: 4 Wks Postoperative
|
69.0 points on a scale
Standard Deviation 19.5
|
67.7 points on a scale
Standard Deviation 17.2
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Daily Living Activities: 12 Wks Postoperative
|
80.2 points on a scale
Standard Deviation 16.5
|
81.2 points on a scale
Standard Deviation 15.4
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Sports/Recreation: Preoperative
|
17.0 points on a scale
Standard Deviation 22.6
|
12.2 points on a scale
Standard Deviation 20.2
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Sports/Recreation: 4 Wks Postoperative
|
20.8 points on a scale
Standard Deviation 29.2
|
28.1 points on a scale
Standard Deviation 36.7
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Sports/Recreation: 12 Wks Postoperative
|
53.0 points on a scale
Standard Deviation 31.8
|
51.6 points on a scale
Standard Deviation 29.3
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Quality of Life: Preoperative
|
24.4 points on a scale
Standard Deviation 24.3
|
27.7 points on a scale
Standard Deviation 26.3
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Quality of Life: 4 Wks Postoperative
|
46.0 points on a scale
Standard Deviation 29.0
|
51.0 points on a scale
Standard Deviation 23.0
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Quality of Life: 12 Wks Postoperative
|
17.0 points on a scale
Standard Deviation 22.6
|
12.2 points on a scale
Standard Deviation 20.3
|
Adverse Events
Vitagel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitagel
n=49 participants at risk
Vitagel \[Orthovita Inc., Malvern, PA\], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
|
Control
n=50 participants at risk
No Vitagel used during primary total knee arthroplasty
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
2/49 • Number of events 2
|
0.00%
0/50
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/49 • Number of events 1
|
4.0%
2/50 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place