rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

Lumbar Spine Degeneration Clinical Trial

Official title:

rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03527966
• Other study ID #: IRB G17008
• Status: Terminated
• Phase: Phase 4
• Start date: July 3, 2017
• Est. completion date: July 27, 2018

Study information

• Verified date: August 2019
• Source: Virtua Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.

Description:

The purpose of this study is to compare the overall efficacy (clinical outcome and radiographic fusion) of Vivigen (cellular allograft product) and rhBMP-2 in patients who undergo a single level lumbar instrumented fusion. Specifically, when compared to their control group counterparts treated to rhBMP-2, we hypothesize that the intervention group administered Vivigen would, following surgery, experience:

1. Comparable mean postoperative leg/back pain score, where the pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible

2. Comparable inpatient length of stay (LOS)

3. Comparable postoperative Oswestry Disability Index (ODI) score (0-no disability, to 100-maximum disability possible), two weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively

4. Comparable fusion rates, evaluated via CT scan I year postoperatively

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or older;

2. Diagnosed with lumbar degenerative/isthmic spondylolisthesis, degenerative disc disease with axial low back pain and neurologic symptoms, failed conservative treatment and eligible for a single level lumbar instrumented fusion;

3. Willing to provide informed consent, participate in study, and comply with study protocol.

Exclusion Criteria:

1. Pregnant or contemplating pregnancy prior to surgery;

2. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);

3. Surgery involving more than 2 vertebral levels;

4. Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests; could also run into potential issues with reimbursement).

5. Lactating women

6. Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin

7. Immune compromised patients

Related Conditions & MeSH terms

• Lumbar Spine Degeneration

Intervention

Biological:
• 5cc Vivigen and local autograft
The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and 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

Locations

Country	Name	City	State
United States	Virtua Memorial Hospital	Mount Holly	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Virtua Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Oswestry Disability Index (ODI) Score	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)	Up to 1 year post surgery
Secondary	Mean Postoperative Leg/Back Pain Score	Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible	Average of 3 days in hospital
Secondary	Mean Inpatient Length of Stay		Average of 3 days in hospital
Secondary	Fusion Rates, Evaluated Via CT Scan I Year Postoperatively		1 year post surgery