Active clinical trials for "Intervertebral Disc Degeneration"

The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.

Surgical methods offered to patients with chronic low back pain are controversial. In addition, new and expensive treatment methods like total disc replacemet (TDR) are a challenge for the health care services. At present, ongoing randomized studies in both Europe and USA are comparing TDR to fusion. However, to our knowledge, no randomized trials have compared TDR to non-surgical treatment. The aim of the present study is to evaluate the effect of a comprehensive and structured non-surgical treatment with TDR surgery in patients with chronic low back pain and localized degenerative disc changes. Main hypothesis: There is no difference in treatment effect between surgery with lumbar total disc prosthesis and a multidisciplinary rehabilitation program measured by Oswestry Disability Index after 1 and 2 years. Secondary hypothesis: There is no difference in cost - effectiveness between surgery with lumbar disc prosthesis and a multidisciplinary rehabilitation program after 1 and 2 years.

Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain new bone growth during the healing process. nanOss Bioactive 3D is approved for use in the U.S., however, additional information is useful to assess its efficacy in the posterolateral spine. The purpose of this study is to assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed degenerative disc disease.

The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.

Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to be effective in reducing neck pain, restoring cervical spinal function and mobility in many types of cervical spine dysfunction. However, the training of stabilizers has not been studied in individuals undergoing cervical spinal surgery, even though these individuals often have problems with residual pain and weakness after the surgery. Purpose: The purpose of this study is to compare the effectiveness of clinical outcomes between an early PT intervention and usual care in patients who have undergone anterior cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved with early PT intervention. Methods: This study is a double-blinded randomized clinical trial with a two-factor (2x3) research design. The patients following ACF surgery will be randomly assigned in one of the two treatment groups: usual care and early intervention. Three outcome measures will be collected pre-operative for baseline, and then at 6-week and 12-week post-operative follow-up visits, including: (1) deep cervical flexor (DCF) strength as determined by the cranio-cervical flexion (CCF) performance test, (2) patient's perceived disability associated neck pain as determined by the Neck Disability Index (NDI) questionnaire, and (3) neck pain level using the numeric pain rating scale (NPRS). In addition, at 6 and 12 weeks, the global rate of change (GROC) scale will be obtained to determine the patient's perception of overall improvement as a result of surgery. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the usual care group will receive only one visit of PT for post-operative instruction. The early intervention group will receive verbal and written instructions for posture and training cervical spine stabilizers in addition to the usual care. The early intervention group also will be asked to perform these exercises at home and keep a log of the exercise. Data Analysis: Two 2x3 MANOVAs with repeated measures will be used to examine the differences in the CCF strength and the NDI scores between groups and at the three different time frames with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the differences in the NPRS and GROC data over time and between groups.

Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative affect [NA]). The purpose of the study is to determine whether CLBP patients with either a high vs. a low or moderate degree of NA have different pain relief responses to oral opioids.

This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® Device using laparoscopic surgical technique as compared to an historical control group treated with Autogenous Bone/LT-CAGE® Device using an open surgical technique in patients with symptomatic degenerative disc disease.

The purpose of this study is to evaluate the feasibility of using the investigational implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral lumbar spinal fusion at two adjacent treatment levels in patients with symptomatic degenerative disc disease.

The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with degenerative cervical disc disease..