NCT04007094

Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery

Terminated NA Results posted Last updated 24 January 2024

What this trial tests

NA trial testing ViviGen Cellular Bone Matrix in Degenerative Disc Disease in 21 participants. Terminated before completion.

Timeline

12 February 2019

Primary endpoint
21 January 2022

21 January 2022

Quick facts

Lead sponsor	Ohio State University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	12 February 2019
Primary completion	21 January 2022
Estimated completion	21 January 2022
Sites	1 location across United States

Drugs / interventions tested

• ViviGen Cellular Bone Matrix

Conditions studied

• Degenerative Disc Disease — all drugs for Degenerative Disc Disease →
• Spinal Stenosis — all drugs for Spinal Stenosis →
• Spondylosis — all drugs for Spondylosis →
• Spondylolisthesis — all drugs for Spondylolisthesis →

Sponsor

Ohio State University

Who can join

18 and older, any sex, with Degenerative Disc Disease or Spinal Stenosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Number of Surgical Levels With Successful Lumbar Fusion Primary · 12 months prospective from surgery

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.

Grade A

Group	Value	95% CI
Left Side - Milled Local Autograft Bone	24
Right Side - Depuy Synthes ViviGen	34

Grade B

Group	Value	95% CI
Left Side - Milled Local Autograft Bone	14
Right Side - Depuy Synthes ViviGen	9

Grade C

Group	Value	95% CI
Left Side - Milled Local Autograft Bone	15
Right Side - Depuy Synthes ViviGen	12

Grade D

Group	Value	95% CI
Left Side - Milled Local Autograft Bone	2
Right Side - Depuy Synthes ViviGen	0

Number of Participants With or Without Changes in Visual Analog Scale Pain Scores Secondary · 12 months prospectively from surgery

The visual analog scale will be used to rate leg and back pain scores from 0-10, with 10 being considered the most painful.

Back Pain Scores Improved on Scale

Group	Value	95% CI
Study Arm	12

Leg Pain Scores Improved on Scale

Group	Value	95% CI
Study Arm	11

Back Pain Scores Worsened on Scale

Group	Value	95% CI
Study Arm	2

Leg Pain Score Worsened on Scale

Group	Value	95% CI
Study Arm	1

Back Pain Score did not change

Group	Value	95% CI
Study Arm	2

Leg Pain Score did not change

Group	Value	95% CI
Study Arm	3

Back Pain Change Unknown/Unreported

Group	Value	95% CI
Study Arm	4

Leg Pain Change Unknown/Unreported

Group	Value	95% CI
Study Arm	5

Oswestry Disability Index (ODI) v2.1a Secondary · 12 months prospectively from surgery

This 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.

Oswestry Disability Index Score Improved

Group	Value	95% CI
Study Arm	9

Oswestry Disability Index Score Worsened

Group	Value	95% CI
Study Arm	3

Oswestry Disability Index Score did not Change

Group	Value	95% CI
Study Arm	1

Oswestry Disability Index Score Unknown/Not Reported

Group	Value	95% CI
Study Arm	7

Adverse events — posted to ClinicalTrials.gov

Time frame: Minimum of 1 year (2 years as available).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Study Arm

Serious: 6/21 (29%)

Deaths: 0/21

Serious adverse events (8 terms)

Reaction	System	Study Arm
Alcohol Withdrawal	General disorders	—
Shoulder Surgeries	Surgical and medical procedures	—
Altered Mental State	Psychiatric disorders	—
Atrial Fibrillation (AFib) With Rapid Ventricular Response (RVR)	Cardiac disorders	—
Hip Arthroplasties	Surgical and medical procedures	—
Wound Dehiscence	Infections and infestations	—
Urinary Tract Infection	Renal and urinary disorders	—
subdural hematoma	Injury, poisoning and procedural complications	—

Other adverse events (12 terms — click to expand)

Reaction	System	Study Arm
Increased Paresthesia or Weakness	Nervous system disorders	—
Worsened Back and/or Leg Pain	Musculoskeletal and connective tissue disorders	—
Epigastric or Abdominal Pain	Gastrointestinal disorders	—
Urinary Tract Infection	Renal and urinary disorders	—
Neck Pain	Musculoskeletal and connective tissue disorders	—
Ileus	Gastrointestinal disorders	—
Falls or injury	General disorders	—
Viral Infections	Infections and infestations	—
Shoulder Pain	Musculoskeletal and connective tissue disorders	—
Basal Cell Carcinoma	Skin and subcutaneous tissue disorders	—
New Diagnosis of Osteoporosis	Musculoskeletal and connective tissue disorders	—
Adjacent Segment Disease	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Alcohol Withdrawal, Shoulder Surgeries, Altered Mental State, Atrial Fibrillation (AFib) With Rapid Ventricular Response (RVR), Hip Arthroplasties, Wound Dehiscence, Urinary Tract Infection, subdural hematoma.

Data from ClinicalTrials.gov NCT04007094 adverse events section.

Sponsor's own description

This is a prospective, single-arm post market study of patients to assess fusion in one or multiple continuous levels of the lumbosacral spine (L1-S1) using ViviGen Cellular Bone Matrix. All subjects will be followed out to 24 months for final assessment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.