Trial Outcomes & Findings for Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery (NCT NCT04007094)
NCT ID: NCT04007094
Last Updated: 2024-01-24
Results Overview
Extent of fusion using the Lenke classification. Radiographic success defined as grade A, partial success grade B and radiographic failure as grades C and D.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
12 months prospective from surgery
Results posted on
2024-01-24
Participant Flow
Unit of analysis: Vertebral Levels
Participant milestones
| Measure |
Left Side - Local Autograft Bone
Left side fusion levels coated with milled local autograft bone
|
Right Side - ViviGen
Right side Fusion Levels Supplemented with Depuy Synthes VigiGen
|
|---|---|---|
|
Overall Study
STARTED
|
21 58
|
21 58
|
|
Overall Study
COMPLETED
|
20 55
|
20 55
|
|
Overall Study
NOT COMPLETED
|
1 3
|
1 3
|
Reasons for withdrawal
| Measure |
Left Side - Local Autograft Bone
Left side fusion levels coated with milled local autograft bone
|
Right Side - ViviGen
Right side Fusion Levels Supplemented with Depuy Synthes VigiGen
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery
Baseline characteristics by cohort
| Measure |
Study Arm
n=21 Participants
Participants will be entered into the single armed study in which one side of the fusion will be coated with milled local autograft bone and the opposite fusion side will be supplemented with an equal volume of Depuy Synthes ViviGen.
ViviGen Cellular Bone Matrix: Study participants will receive local autograft milled bone on one side of the fusion and an equal amount of Depuy Synthes ViviGen on the opposite side of the fusion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=99 Participants
|
|
Age, Continuous
|
70.95 years
STANDARD_DEVIATION 9.34 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 months prospective from surgeryPopulation: Surgical Levels have two sides being evaluated: 55 levels times 2: (Left- Autograft and Right - ViviGen)
Extent of fusion using the Lenke classification. Radiographic success defined as grade A, partial success grade B and radiographic failure as grades C and D.
Outcome measures
| Measure |
Left Side - Milled Local Autograft Bone
n=55 Surgical Levels and Sides
Left side of the fusion will be coated with milled local autograft bone.
|
Right Side - Depuy Synthes ViviGen
n=55 Surgical Levels and Sides
The Right fusion side will be supplemented with Depuy Synthes ViviGen.
|
|---|---|---|
|
The Number of Surgical Levels With Successful Lumbar Fusion
Grade A
|
24 Surgical Levels
|
34 Surgical Levels
|
|
The Number of Surgical Levels With Successful Lumbar Fusion
Grade B
|
14 Surgical Levels
|
9 Surgical Levels
|
|
The Number of Surgical Levels With Successful Lumbar Fusion
Grade C
|
15 Surgical Levels
|
12 Surgical Levels
|
|
The Number of Surgical Levels With Successful Lumbar Fusion
Grade D
|
2 Surgical Levels
|
0 Surgical Levels
|
SECONDARY outcome
Timeframe: 12 months prospectively from surgeryThe visual analog scale will be used to rate leg and back pain scores from 0-10, with 10 being considered the most painful.
Outcome measures
| Measure |
Left Side - Milled Local Autograft Bone
n=20 Participants
Left side of the fusion will be coated with milled local autograft bone.
|
Right Side - Depuy Synthes ViviGen
The Right fusion side will be supplemented with Depuy Synthes ViviGen.
|
|---|---|---|
|
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Leg Pain Score Worsened on Scale
|
1 participants
|
—
|
|
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Back Pain Scores Improved on Scale
|
12 participants
|
—
|
|
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Leg Pain Scores Improved on Scale
|
11 participants
|
—
|
|
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Back Pain Scores Worsened on Scale
|
2 participants
|
—
|
|
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Back Pain Score did not change
|
2 participants
|
—
|
|
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Leg Pain Score did not change
|
3 participants
|
—
|
|
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Back Pain Change Unknown/Unreported
|
4 participants
|
—
|
|
Number of Participants With or Without Changes in Visual Analog Scale Pain Scores
Leg Pain Change Unknown/Unreported
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: 12 months prospectively from surgeryThis survey will be used to assess how back pain affects patients' ability to function in everyday life. We will look to see if subjects' scores improve or worsen on the Oswestry Disability Index scale (ODI) which can range from 0% to 100% with higher scores indicating higher levels of disturbance in everyday life.
Outcome measures
| Measure |
Left Side - Milled Local Autograft Bone
n=20 Participants
Left side of the fusion will be coated with milled local autograft bone.
|
Right Side - Depuy Synthes ViviGen
The Right fusion side will be supplemented with Depuy Synthes ViviGen.
|
|---|---|---|
|
Oswestry Disability Index (ODI) v2.1a
Oswestry Disability Index Score Unknown/Not Reported
|
7 participants
|
—
|
|
Oswestry Disability Index (ODI) v2.1a
Oswestry Disability Index Score Improved
|
9 participants
|
—
|
|
Oswestry Disability Index (ODI) v2.1a
Oswestry Disability Index Score Worsened
|
3 participants
|
—
|
|
Oswestry Disability Index (ODI) v2.1a
Oswestry Disability Index Score did not Change
|
1 participants
|
—
|
Adverse Events
Study Arm
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Arm
n=21 participants at risk
Participants will be entered into the single armed study in which one side of the fusion will be coated with milled local autograft bone and the opposite fusion side will be supplemented with an equal volume of Depuy Synthes ViviGen.
ViviGen Cellular Bone Matrix: Study participants will receive local autograft milled bone on one side of the fusion and an equal amount of Depuy Synthes ViviGen on the opposite side of the fusion
|
|---|---|
|
General disorders
Alcohol Withdrawal
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Surgical and medical procedures
Shoulder Surgeries
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Psychiatric disorders
Altered Mental State
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Cardiac disorders
Atrial Fibrillation (AFib) With Rapid Ventricular Response (RVR)
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Surgical and medical procedures
Hip Arthroplasties
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Infections and infestations
Wound Dehiscence
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Injury, poisoning and procedural complications
subdural hematoma
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
Other adverse events
| Measure |
Study Arm
n=21 participants at risk
Participants will be entered into the single armed study in which one side of the fusion will be coated with milled local autograft bone and the opposite fusion side will be supplemented with an equal volume of Depuy Synthes ViviGen.
ViviGen Cellular Bone Matrix: Study participants will receive local autograft milled bone on one side of the fusion and an equal amount of Depuy Synthes ViviGen on the opposite side of the fusion
|
|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Musculoskeletal and connective tissue disorders
Worsened Back and/or Leg Pain
|
14.3%
3/21 • Number of events 4 • Minimum of 1 year (2 years as available).
|
|
Gastrointestinal disorders
Epigastric or Abdominal Pain
|
14.3%
3/21 • Number of events 3 • Minimum of 1 year (2 years as available).
|
|
Nervous system disorders
Increased Paresthesia or Weakness
|
23.8%
5/21 • Number of events 5 • Minimum of 1 year (2 years as available).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Gastrointestinal disorders
Ileus
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
General disorders
Falls or injury
|
4.8%
1/21 • Number of events 2 • Minimum of 1 year (2 years as available).
|
|
Infections and infestations
Viral Infections
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Skin and subcutaneous tissue disorders
Basal Cell Carcinoma
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Musculoskeletal and connective tissue disorders
New Diagnosis of Osteoporosis
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
|
Musculoskeletal and connective tissue disorders
Adjacent Segment Disease
|
4.8%
1/21 • Number of events 1 • Minimum of 1 year (2 years as available).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place