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Vivigen vs rhBMP-2 in Lumbar Fusion Procedures
NCT03527966Phase 4
Key facts
- Status
- Terminated
- Start
- Jul 2017
- Primary completion
- Jul 2018
- Countries
- 1
- Sponsor
- Virtua Health
- Modality
- Implantable Devices, Implantable Hydrogels, Cell Therapies
- Drugs
- ViviGen
- Conditions
- lumbar intervertebral disc degenerative disease (LDDD)
01
Overview
Phase 4, randomised trial of ViviGen in lumbar intervertebral disc degenerative disease (LDDD) (2 arms), sponsored by Virtua Health. Primary endpoint: Oswestry Disability Index at 1 year. Started Jul 2017; status: terminated.
02
Design
2 arms- Study design
- Randomized
Vivigen + local autograft
5cc Vivigen and local autograft administered during single level lumbar instrumented fusion
rhBMP-2 + local autograft
Small kit rhBMP-2 with local autograft administered during single level lumbar instrumented fusion
03
Who it enrols
Adult patients diagnosed with lumbar degenerative/isthmic spondylolisthesis or degenerative disc disease with axial low back pain and neurologic symptoms who have failed conservative treatment and are eligible for a single level lumbar instrumented fusion. Excludes pregnant/lactating women, patients with serious spinal conditions, surgery involving >2 vertebral levels, worker's compensation cases, immune compromised patients, and those with specific allergies.
04
Endpoints
Primary
Oswestry Disability Index
Secondary
Postoperative Leg/Back Pain Score
Inpatient Length of Stay
Fusion Rates
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