Trial Outcomes & Findings for rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures (NCT NCT03527966)
NCT ID: NCT03527966
Last Updated: 2019-08-28
Results Overview
The ODI is one of the most commonly utilized condition-specific measures of disability used in the management of spinal disorders (0-no disability, to 100-maximum disability possible)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
Up to 1 year post surgery
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Intervention Group - 5cc Vivigen and Local Autograft
5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
|
Control Group - Small Kit rhBMP-2 With Local Autograft
Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Intervention Group - 5cc Vivigen and Local Autograft
5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
|
Control Group - Small Kit rhBMP-2 With Local Autograft
Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
Baseline characteristics by cohort
| Measure |
Intervention Group - 5cc Vivigen and Local Autograft
n=3 Participants
5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
|
Control Group - Small Kit rhBMP-2 With Local Autograft
Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
—
|
52.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year post surgeryPopulation: Patients did not attend every follow up visit and then were ultimately lost to follow up. Study was also terminated early when the PI left his practice so on patients were never randomized in the control group.
The ODI is one of the most commonly utilized condition-specific measures of disability used in the management of spinal disorders (0-no disability, to 100-maximum disability possible)
Outcome measures
| Measure |
Intervention Group - 5cc Vivigen and Local Autograft
n=3 Participants
5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
|
Control Group - Small Kit rhBMP-2 With Local Autograft
Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
|
|---|---|---|
|
Mean Oswestry Disability Index (ODI) Score
ODI at Two weeks
|
78.5 score on a scale
Interval 70.0 to 87.0
|
—
|
|
Mean Oswestry Disability Index (ODI) Score
ODI at Six weeks
|
42 score on a scale
Interval 26.0 to 58.0
|
—
|
|
Mean Oswestry Disability Index (ODI) Score
ODI at Three months
|
36.6 score on a scale
Interval 8.0 to 70.0
|
—
|
|
Mean Oswestry Disability Index (ODI) Score
ODI at Six months
|
36 score on a scale
Interval 36.0 to 36.0
|
—
|
SECONDARY outcome
Timeframe: Average of 3 days in hospitalPopulation: Study was terminated early before any patients were randomized to the control group.
Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible
Outcome measures
| Measure |
Intervention Group - 5cc Vivigen and Local Autograft
n=3 Participants
5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
|
Control Group - Small Kit rhBMP-2 With Local Autograft
Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
|
|---|---|---|
|
Mean Postoperative Leg/Back Pain Score
|
5.3 score on a scale
Interval 0.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Average of 3 days in hospitalPopulation: The study was terminated early before any patients were randomized to the control group.
Outcome measures
| Measure |
Intervention Group - 5cc Vivigen and Local Autograft
n=3 Participants
5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
|
Control Group - Small Kit rhBMP-2 With Local Autograft
Small kit rhBMP-2 with local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
|
|---|---|---|
|
Mean Inpatient Length of Stay
|
1 days
Interval 1.0 to 1.0
|
—
|
SECONDARY outcome
Timeframe: 1 year post surgeryPopulation: No patient returned for their 1 year post op scan
Outcome measures
Outcome data not reported
Adverse Events
Intervention Group - 5cc Vivigen and Local Autograft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group - Small Kit rhBMP-2 With Local Autograft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place