7 rows The purpose of this multi-center randomized clinical study is to establish the safety and. The Over-Volunteering Prevention System TOPS is run by the Health Research Authority and helps prevent volunteers from taking part in trials of new medicines too frequently.
Tops System For The Usa Patients Fda Approval Details Studies
Though surgeons have to research the system and figure out how to use it correctly things are progressing well.
Tops system clinical trials. It is a research study offered to volunteers who suffer from spondylolisthesis spinal stenosis and additional spinal symptoms. The study compares the TOPS system to lumbar fusion in treating volunteers who suffer from spondylolisthesis spinal. Sibley Memorial Hospital is one of 30 hospitals nationwide to participate in the Premia Spine TOPS System clinical trial.
Patients will be randomised to either the Tops System or lumbar fusion ie an interbody cage plus screws and rods with a 67 likelihood of receiving the Tops device. This study is designed to test the investigational use of the Total Posterior Spine TOPS System in patients who have been diagnosed with spine-related conditions. However you have other choices available to you including TOPS.
An alternative to spinal fusion surgery. The purpose of this trial is to assess whether the Total Posterior Spine System TOPS System is more effective than transforaminal lumbar interbody fusion TLIF when used to stabilize a single lumbar level L2 - L5 following surgical decompression in patients diagnosed with 1 at least moderate lumbar spinal stenosis and 2 Grade 1 spondylolisthesis or retrolisthesis and 3. The Penn Spine Center team is actively recruiting for this trial.
Since the clinical trials are relatively new and the number of participants is small the long-term outcomes and overall results are still yet to be known. Eligibility Sibley Memorial Hospital Patient Care Neurosurgery TOPS Clinical Trial. Premia Spine was granted FDA approval to commence an IDE investigation of the TOPS System in 330 to 476 patients at up to 30 investigational centers in the United States.
Back to Neurosurgery Sibley Memorial Hospital Main Menu. Of our knowledge participated in two trials simultaneously. Hat is the TOPS clinical trial.
TOPS has reduced to. Patients are randomized into either the TOPS 220 patients or fusion arm 110 patients of the study. But because degenerative spinal diseases can cause severe pain and physical disability the greatest risk of the TOPS System treatment like all fusion surgeries is the failure to alleviate pain.
47 rows The purpose of this trial is to assess whether the Total Posterior Spine System TOPS. Premia Spine has worked hard to develop this system test it do clinical trials and is now offering it to various countries. Penn Medicine is the only academic medical institution in the region currently offering the TOPS implant and one of only 30 hospitals nationwide to participate in the Premia Spine TOPS System clinical trial.
Physicians will be comparing the TOPS to lumbar fusion in a randomized clinical trial. The purpose of this trial is to assess whether the Total Posterior Spine System TOPS System is more effective than transforaminal lumbar interbody fusion TLIF when used to stabilize a single lumbar level L2 - L5 following surgical decompression in patients diagnosed with 1 at least moderate lumbar spinal stenosis and 2 Grade 1 spondylolisthesis or retrolisthesis and 3. To enroll in this study you must be.
Conclusion TOPS is widely used and effective and helps research units to comply with UK clinical trial regulations. The purpose of this trial is to assess whether the Total Posterior Spine System TOPS System is more effective than transforaminal lumbar interbody fusion TLIF when used to stabilize a single lumbar level L2 - L5 following surgical decompression in patients diagnosed with 1 at least moderate lumbar spinal stenosis and 2 Grade 1 spondylolisthesis or retrolisthesis and 3 thickening of the ligamentum. If the TOPS System fails to treat the patients.
All personally identifiable information gathered is securely held and fairly processed. The TOPS clinical trial is a research study to determine the safety and efficacy of the TOPS System by the US. Smartsheet an online work execution platform empowers pharmaceutical companies and clinical research organizations to track manage and report on clinical tests and trials.
The TOPS System is approved for use in Europe and several other. The investigational device exemption IDE study will take place in 30 institutions and enrol 330 subjects. Premia Spine TOPS System.
Patients MUST have spinal stenosis AND spondylolisthesis of the lumbar spine. With its familiar spreadsheet format Smartsheet enables teams to easily get started and effectively collaborate. And Matthew Ammerman MD.
An alternative to spinal fusion surgery this procedure is being led by Sibley neurosurgeons Joshua Ammerman MD Joshua Wind MD. Food and Drug Administration. Between 35 and 80 years of age.
