View clinical trials related to Spinal Diseases.
Filter by:The study goal of RELApSE is to evaluate the relationships between radiological data and patients reported outcome. Restoration of Sagittal alignment and Pelvic Index (PI)-Lumbar Lordosis (LL) mismatch is closely associated with a better outcome in spinal deformities, while there is still a lack of consistent evidence regarding short-segment arthrodesis for lumbar degenerative pathology. Over the past 10 years, an increasing number of publications reported associations between the presence of PI-LL mismatch, reduced lumbar lordosis, increased pelvic tilt, and outcome of lumbar arthrodesis for degenerative lumbar disease. Other authors, on the other hand, reported an absence of correlation between the same parameters and clinical outcome. In addition, several authors have been reported evidence regarding association of adjacent level disc degeneration and elevated pelvic tilt, persistent PI-LL mismatch and altered LL4-S1/LL ratio. Also on this aspect, other studies identify different elements as predisposing factors for junctional pathology. The definitive value for lumbar degenerative pathology of these aspects in relation to the surgical outcome remains to be clarified without consolidated evidence. The RELApSE study is the first prospective and multicenter study on these topics. Starting from a very heterogeneous population in terms of clinical conditions, pathology and surgical treatment options, the study methods is to make the population homogeneous on some data available in all patients end that can be analyzed independently. These data are: pelvic parameters (pelvic incidence, pelvic tilt, sacral slope), segmental lumbar lordosis (LS), global lumbar lordosis (LL), PI-LL mismatch and L4-S1/LL lordosis ratio; clinical results based on administered questionnaires (Oswestry disability index, Short Form-12) and overall outcome assessment at FU (6 point scale: excellent (completely resolved symptoms), good (good clinical improvement, minor symptoms), fair (improvement compared to preoperative but still with relevant symptoms), unchanged (symptoms similar to preoperative), negative (worsening of symptoms compared to preoperative); severely worsened (reduction of personal autonomy compared to preoperative due to neurological deficits); occurrence of symptomatic junctional pathology (yes / no), need for surgical revision of the operated level (yes / no) or of the adjacent level (yes / no).No interference is foreseen on the patient's diagnostic-therapeutic path or technical treatment options chosen by partecipating surgeons. Furthermore, no form of experimentation with techniques or materials is envisaged. Data collection is prospective in the context of normal clinical activity.
The aim of this study is to investigate the effect of the Mulligan mobilization technique on pain intensity and range of motion individuals with neck pain. The patients were randomized into two groups. Group 1 is the Mulligan Mobilization group and the second group is the control group.
The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD) at two contiguous levels. Subjects will be randomized in a 2:1 ratio to the two-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the two-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.
The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD). Subjects will be randomized in a 2:1 ratio to the one-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the one-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.
One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization postoperatively. This study is the first prospective trial utilizing the Apple Watch to objectively track patients before and after elective spine surgery. The investigators hypothesize that the ability of patients to track their own activity and discuss with their surgeon objective mobilization goals will not only help patients achieve empowerment in their own care but also improve their overall satisfaction and self-reported outcomes after spine surgery.
Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms.
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 one or two - level posterolateral lumbar fusion.
This is a single-center prospective randomized investigation of patients undergoing surgical arthrodesis for single or multi-level cervical disease, resulting in cervical radiculopathy. Patients indicated for surgery for cervical degenerative disease (CDD) will be screened for yellow flags using validated tools to assess pain. Cognitive-behavioral therapy (CBT) will be used to modify yellow flags in spine patients. All patients at risk will be stratified by risk rating and randomly assigned to 2 groups; sham treatment (N=20) or CBT (N=20). The goal of this study is to unmask the relationship between psychological distress and clinical outcomes in patients undergoing surgical treatment for cervical degenerative disease resulting in combinations of neck pain and radiculopathy, and to determine the effectiveness of a brief psychological intervention on subset of patients who screen positive for psychological distress prior to their surgeries.
Purpose: The incidence of surgery for Degenerative lumbar Disc Disease (DDD). According to the national spine registries in Sweden, Norway and Denmark, there is a difference in surgical incidence between these countries. The cause for this difference is not known. It may reflect a difference in incidence of lumbar disc hernia, but with a similar socio-economic and ethnical background in these countries, it is more likely that the differences are due to varying surgical indications. Comparing indications for surgery, patient reported outcome and factors predictive for outcome after surgery for lumbar disc decease in these countries could provide information about optimal indications for surgery. Hypotheses: (i) there are no differences in patient-reported outcome after surgery between these countries, (ii) there are no differences in indications for surgery between these countries and (iii), factors that predict outcome are similar in these countries. Method of research: By using data from three Nordic national spine registers, investigators will compare baseline data, indications for surgery and patient reported outcome one year after surgery for lumbar disc decease. Register based studies have advantages such as large sample sizes, reflecting real life, but they also have limitations such as lower follow-up rates than clinical trials. A non-response analysis will be performed to take this into account.
Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.