Degenerative Disc Disease Lumbar Spondylolisthesis Grade I Spinal Fusion Bone Transplantation Intervertebral Disc Degeneration Lumbar Vertebrae Recombinant Proteins Collagen Back Pain Clinical Trial Orthopedic Procedures Biocompatible Materials
Conditions
Interventions
OSSICURE Bone Graft consists of recombinant human bone morphogenetic protein-2 (rhBMP-2) solution applied to an absorbable collagen sponge (ACS) carrier. It is implanted during lumbar spinal fusion su
Experimental Device,Active Comparator Device
OSSICURE Bone Graft,Infuse Bone Graft (Medtronic)
Sponsors
National Science and Technology Development Agency
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The indication studied is degenerative disc disease (DDD) accompanied by back pain with or without leg pain at a single level between L4 and S1 confirmed by history and radiographic studies. DDD will be determined to be present if one or more of the following are noted: instability (defined as angulation of at least 5 degrees and/or translation of at least 4mm on flexion/extension radiographs); osteophyte formation; decreased disc height; ligamentous thickening; disc degeneration/herniation; or facet joint degeneration 2. A pre-op Oswestry Low Back Pain Disability Questionnaire score of 35 or more 3. If spondylolisthesis were present, it could be no greater than grade I 4. If non-responsive to non-operative treatment for at least 6 months 5. Skeletally mature 6. Able to understand and willing to comply with study procedures, restrictions and requirements, as judged by the Investigator
Exclusion criteria
Exclusion criteria: 1. History of lumbosacral spinal surgery at any level 2. Active malignancy 3. Active local or systemic infection 4. Severe obesity (BMI at least 40 kg/m2 or IBW at least 40%) 5. History or current alcohol or substance abuse 6. History of allergy to titanium, protein pharmaceuticals, collagen or bovine products 7. Previous exposure to rhBMP-2 and injectable collagen implants 8. Medical conditions that may influence osteogenesis or impact study outcomes considered by investigators 9. Participated in another interventional trial within 28 days prior to implantation 10. Pregnancy, breast-feeding or intention to get pregnant for at least 16 weeks post-implantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion 6 months and 12 months post-surgery Radiographic assessment (X-ray and CT) of bridging bone, lack of flexion/extension motion, and radiolucency.,Pain Baseline (preoperatively and intraoperative) and 6 weeks, 3 months, 6 months, 12 months post-surgery Oswestry Low Back Pain Disability Questionnaire,Function Baseline, 6 weeks, 3 months, 6 months, 12 months Oswestry Low Back Pain Disability Questionnaire,Fusion Success Rate 6 months and 12 months post-surgery Number of individual subjects categorized as a success divided by the total number of subjects evaluated | — |
Secondary
| Measure | Time frame |
|---|---|
| Neurological Status Baseline, 6 weeks, 3 months, 6 months, 12 months Clinical neurological examination,Adverse Events Throughout study duration (from baseline through 12 months follow-up) Number and severity of device-related and procedure-related adverse events recorded throughout study,Immunogenicity Preoperatively and 3 months postoperatively ELISA measurement of antibodies to rhBMP-2, bovine Type I collagen, and human Type I collagen | — |
Countries
Thailand
Contacts
Public ContactSirichai Wilartratsami
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed