Active clinical trials for "Spondylolisthesis"

The goal of the proposed research is to test the feasibility of a functional progression program to reduce cost and possible radiation exposure for adolescent athletes with low back pain. Specifically the investigators plan to test the feasibility of using progression in rehabilitation to pragmatically differentially diagnose and treat adolescent athletes with low back pain, instead of using advanced imaging which is the current practice. The investigators propose to recruit 20 participants, with 10 of usual care (advanced imaging) and 10 of proposed intervention (functional progression) to assess the feasibility of using functional progress to guide treatment. The outcomes measured will be number of days for rest, time to start regular rehabilitation, pain experienced, functional outcomes, ability to return to sport, time needed to return to sport. If this pilot demonstrates the feasibility and a decreased rate of advanced imaging and similar clinical outcomes the investigators plan to progress this work into larger trials.

This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.

Ankasa Regenerative Therapeutics, Inc. (Ankasa) is developing ART352-L, a liposomal formulation of recombinant human Wnt3A protein, that is applied ex vivo, to harvested autologous bone grafts (autograft) to enhance the osteogenic properties of the autograft prior to reimplantation in orthopedic surgeries. This is a phase 1/2 open label safety evaluation of ART352-L treated autologous bone grafts in patients undergoing posterolateral lumbar spinal fusion to treat single level degenerative spondylolisthesis. The primary objective of the study is to evaluate the safety and tolerability of ART352-L treated local bone autografts in patients being treated for this condition, with the secondary objective to evaluate the rates of early and overall spinal fusion. Additionally, changes in patient mobility and quality of life measures from baseline following treatment with ART352-L will be evaluated.

This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.

The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation of the performed reposition to come to satisfactory clinical results.

This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Enrollment period will be approximately 12-18 months; each Principal Investigator/Study Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7 subject visits to the study center from screening through the final follow-up visit.

Degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting nerve roots. It is commonly associated with low back and leg pain, and is a frequent reason for spine surgery particularly in individuals over age 65 years. Recently novel minimally invasive surgical techniques have heightened public and government interest by touting benefits of reduced approached-related morbidity which in turn leads to quicker recovery, shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost. However, there is no randomized controlled trial evidence to describe the actual advantages and disadvantages associated with minimally invasive spinal fusion. This pilot study is a randomized control trial comparing minimally invasive MID-line Lumbar Fusion (MIDLF) to traditional "open" posterior lumbar interbody fusion (PLIF) with respect to length of stay, approach related morbidity, patient centered outcome measures, and cost-effectiveness in the treatment of degenerative lumbar spondylolisthesis.

An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.

The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion using autograft with posterior stabilization.

This is a clinical trial for evaluating the safety and effectiveness of the Mokhuri intensive treatment program regarding pain and function before and after treatment between a group receiving the Mokhuri intensive treatment program (Chuna, acupuncture, and patient education) for five weeks and another group receiving non-surgical conventional standard treatment (drugs for pain relief, epidural steroid injection treatment, and physical therapy). The trial will be conducted through international cooperation between Mayo Clinic in the United States and Mokhuri Oriental Medicine Hospital in Korea. All subjects in Korea and the US will be selected based on the same inclusion criteria and exclusion criteria. All subjects in the treatment arm will receive the same treatment in Korea and the US. In collaboration and with the support of Mayo Clinic's Department of Integrative Medicine and Health, and to ensure treatment consistency between Korea and the US, an acupuncturist from the USA will travel to Korea and train on-site for one month in Mokhuri hospital. The trial subjects who agree to participate in the clinical trial after providing informed consent will receive the required examinations and tests according to the clinical trial plan. If they are appropriate for this clinical trial and eligible based on the Inclusion and exclusion criteria, they will be randomly assigned to the group that will undergo the focused Mokhuri intensive treatment program and to the group that will receive non-surgical conventional treatment on their second visit. All the subjects in this study will be educated regarding the study procedure and scheduled visits and will participate in the allocated treatments for five weeks. Afterwards, clinical outcomes of both groups will be evaluated after end of the treatments from between a week and five weeks (within +7 days). The clinical trial ends after the follow-up evaluations that will take place 12 weeks, 24 weeks, 48 weeks, and 96 weeks after the end of the treatment evaluation.