An observational study in Degenerative Disc Disease, sponsored by Orthofix Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by Orthofix Inc. · Observational
The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined with an interbody spacer and supplemental posterior fixation will result in fusion rates and clinical outcomes similar to those with other routinely used autograft and allograft materials including: fusion, improvement in pain and function, maintenance of lower extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.
Degenerative disorders of the lumbar spine can lead to a multitude of clinical problems including back pain and/or leg pain secondary to nerve compression and/or deformity. When conservative (non-surgical) treatment fails after at least a 6 month period and/or non-operative treatment is not indicated, patients and physicians may turn to a surgical solution. Surgical options consist basically of decompressing nerves, correcting and/or stabilizing deformities if required and fusing the segment, depending on the clinical situation. The "gold standard" for aiding healing in spinal fusion surgeries is the harvesting of autograft from the patient's iliac crest and placing it in and around the segments of the spine that are intended to be fused. Autograft is considered the "gold standard" because it contains the essential elements required for successful bone grafting: osteogenesis, osteoconduction, and osteoinduction.
However, the morbidity of harvesting autograft has been well documented and includes chronic donor-site pain, infection, neurologic injury, blood loss, deformity, bowel injury, hernia, and prolonged surgical and hospitalization time. There are now a number of products on the market to minimize or replace the use of autograft. However, few of these products contain all three essential bone-forming elements (osteogenesis, osteoconduction, and osteoinduction) in a single, stand alone product.
Trinity Evolution is a novel, allogeneic cancellous bone matrix containing viable osteoprogenitor cells, mesenchymal stem cells and a demineralized cortical bone (DCB) component to provide the required osteoconduction, osteogenesis, and osteoinduction necessary for successful bone grafting. Preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is considered an allograft and as such is a "minimally manipulated" tissue and is labeled for bone repair for spinal, orthopedic and podiatric indications where autograft is used. The dosage will be dependent upon the specific requirements of the case.
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's enrollment of 207 is above the median of 120 across 166 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Orthofix Inc. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with symptomatic lumbar degenerative disc disease scheduled to undergo PLIF or TLIF.
Exclusion Criteria:
Fusion Rates for Trinity Evolution
Time frame: Operative to 24 months follow-up
NDI relative improvement; VAS improvement; Maintenance or improvement of neurological function
Time frame: Pre-op to 24 months follow-up
Complication Rates for Trinity Evolution
Time frame: Operative to 24 months
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration→
Orthofix Inc.