---
title: rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
nct_id: NCT03527966
overall_status: TERMINATED
phase: PHASE4
sponsor: Virtua Health, Inc.
study_type: INTERVENTIONAL
primary_condition: Lumbar Spine Degeneration
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03527966.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03527966"
ct_last_update_post_date: 2019-08-28
last_seen_at: "2026-05-12T06:22:26.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

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

**NCT ID:** [NCT03527966](https://clinicaltrials.gov/study/NCT03527966)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** PI left the institution
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 3
- **Lead Sponsor:** Virtua Health, Inc.
- **Conditions:** Lumbar Spine Degeneration
- **Start Date:** 2017-07-03
- **Completion Date:** 2018-07-27
- **CT.gov Last Update:** 2019-08-28

## Brief 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.

## Detailed 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Intervention group - 5cc Vivigen and local autograft** (ACTIVE_COMPARATOR)
- **Control group - small kit rhBMP-2 with local autograft** (ACTIVE_COMPARATOR)

## Interventions

- **5cc Vivigen and local autograft** (BIOLOGICAL) — 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** (BIOLOGICAL) — The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft

## Primary Outcomes

- **Mean Oswestry Disability Index (ODI) Score** _(time frame: Up to 1 year post surgery)_ — 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)

## Secondary Outcomes

- **Mean Postoperative Leg/Back Pain Score** _(time frame: Average of 3 days in hospital)_
- **Mean Inpatient Length of Stay** _(time frame: Average of 3 days in hospital)_
- **Fusion Rates, Evaluated Via CT Scan I Year Postoperatively** _(time frame: 1 year post surgery)_

## Locations (1)

- Virtua Memorial Hospital, Mount Holly, New Jersey, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.virtua memorial hospital|mount holly|new jersey|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03527966*  
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