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The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a single level posterolateral lumbar fusion
This is a prospective randomized, non-blinded, controlled study. Patients with a diagnosis of degenerative disc disease and/or up to grade I spondylolisthesis and planning to undergo a 1-level instrumented posterolateral lumbar fusion surgery between L1-S1 will be screened. If eligible and the subject meets all the inclusion criteria and none of the exclusion criteria, the subject will be approached about study participation by the surgeon. If the subject agrees to participate, the consent process will be initiated by the study coordinator. Once the patient has been consented; data including medical history, neurological exam, patient questionnaires (visual analogue pain score (VAS), Oswestry low-back disability questionnaire (ODI), short form health survey (SF-36)) will be collected. Randomization will occur once a surgery date has been scheduled so the appropriate instrumentation can be boarded accordingly. A randomization envelope will reveal randomization treatment group. The envelopes will be generated in a 1:1 fashion and be randomly allocated to an assigned study identification number.
Subjects will be randomized to either: 1) treatment arm where the investigator will use an FDA approved/cleared DePuy Synthes spinal pedicle screw system with ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft or the 2) control arm where the investigator use the same DePuy Synthes spinal pedicle screw system with local autologous bone graft mixed with cortical/cancellous allograft. Both treatment groups represent standard of care lumbar fusion surgeries using two types of bone graft options to create the arthrodesis as comparators.
Once the lumbar fusion surgery has taken place as planned; data will be collected regarding the surgery performed, including operative time, amount of bone graft used, spinal system used, length of hospital stay, and adverse events/complications.
Study subjects will be followed up at 6-weeks, 3-months, 6-months, and 12-months postoperatively at the private practice or clinic. During these routine (standard of care) postoperative visits, subjects will complete questionnaires (VAS, ODI, SF-36, patient satisfaction) and have neurological exam (lumbar spine exam, see appendix 1) completed by the investigator. Adverse events related to device and/or procedure will be evaluated as each postoperative visit. Anteroposterior (AP) and lateral x-rays will be performed at all visits with flexion and extension x-rays added at baseline, 3-months, 6-months, and 12-months. A CT scan of the lumbar spine will be performed during the 12-month postoperative time frame at the Beaumont-Royal Oak Imaging Center. Radiographic analysis will be performed and evaluated for fusion status as evidenced by bony bridging, presence of radiolucency, and development of pseudoarthrosis at each follow-up visit.
This study design reflects the current standard of care for lumbar spinal stenosis, degenerative disc disease and lumbar degenerative spondylolisthesis. Lumbar fusion surgery using pedicle screw fixation with autograft and allograft bone grafting options is treatment of choice after conservative (non-surgical) therapies have been implemented and failed.
ViviGen® Cellular Bone Matrix, Local Bone Autograft
William Beaumont Hospital
William Beaumont Hospitals
Published on BioPortfolio: 2018-11-13T18:11:20-0500
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A specialized CONNECTIVE TISSUE that is the main constituent of the SKELETON. The principle cellular component of bone is comprised of OSTEOBLASTS; OSTEOCYTES; and OSTEOCLASTS, while FIBRILLAR COLLAGENS and hydroxyapatite crystals form the BONE MATRIX.
Fixation of the ANTERIOR CRUCIATE LIGAMENT, during surgical reconstruction, by the use of a bone- patellar tendon autograft.
The eight bones of the wrist: SCAPHOID BONE; LUNATE BONE; TRIQUETRUM BONE; PISIFORM BONE; TRAPEZIUM BONE; TRAPEZOID BONE; CAPITATE BONE; and HAMATE BONE.
Bone-forming cells which secrete an EXTRACELLULAR MATRIX. HYDROXYAPATITE crystals are then deposited into the matrix to form bone.
The continuous turnover of bone matrix and mineral that involves first, an increase in resorption (osteoclastic activity) and later, reactive bone formation (osteoblastic activity). The process of bone remodeling takes place in the adult skeleton at discrete foci. The process ensures the mechanical integrity of the skeleton throughout life and plays an important role in calcium homeostasis. An imbalance in the regulation of bone remodeling's two contrasting events, bone resorption and bone formation, results in many of the metabolic bone diseases, such as OSTEOPOROSIS.
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Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...