View clinical trials related to Degenerative Disc Disease.
Filter by:This is a prospective randomised study. Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion. Secondary objectives: Assess clinical outcome measurements.
The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion. The secondary objective of this clinical trial is to assess clinical outcome measurements.
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1. All subjects in this study will undergo interbody fusion via Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior instrumentation.
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.
The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental anterior 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 anterior 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 upper extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.
This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their XLIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a TLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a PLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells attached to the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 20,000 cases worldwide.
The NuBac device is indicated for reconstruction following nucleotomy in skeletally mature patients at least 18 years of age with symptomatic single level degenerative disc disease (DDD) at L4/L5 only. DDD is defined as discogenic back pain with or without leg pain; with degeneration of the disc as confirmed by patient history, physical examination, radiographic studies showing: decreased disc height, contained herniated nucleus, vacuum phenomenon (dark disc) OR positive discography at the affected level. These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level and should have failed at least six months of conservative, non-operative care. Demonstrate non-inferiority compared to ProDisc.
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.