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9 active trials for Cervical Myelopathy

Long-term Follow-up Motion Analysis of ACD Versus ACDA

Rationale: Cervical degenerative disc disease (CDDD) is a common cause of cervical radiculopathy, myelopathy or myeloradiculopathy. Surgical treatment is indicated when conservative therapies do not provide sufficient relief or when neurological complaints are progressive. The main surgical techniques are anterior cervical discectomy with (ACDF) or without fusion (ACD), whereas both techniques result in high fusion rates. Short term outcomes of surgery show good clinical results. Long term follow-up shows a drop-in satisfaction rates, often due to the occurrence of new complaints. Pathology is often located at levels adjacent to the previously operated segment, known as adjacent segment disease (ASDis). This is thought to be the results of loss of motion at the previously operated and fused segment. Anterior cervical discectomy with arthroplasty (ACDA) is developed in an effort to reduce the incidence of ASDis by preserving physiological motion in the operated segment. Objective: To investigate physiological motion of the cervical spine the investigators will analyze motion patterns at the long-term in patients who underwent surgical treatment for CDDD, either ACD or ACDA. Study design: Fundamental research. This is a prospective study that includes a cohort of patients previously operated in the setting of a randomized controlled trial. Study population: Adult patients with an indication of surgical treatment for cervical radiculopathy as a consequence of CDDD were enrolled in an RCT between 2007 and 2014 and assigned to undergo ACD or ACDA. Flexion and extension cinematographic recordings of the cervical spine were performed, with the last one at one-year follow-up. The majority of patients in the ACDA group (80%) showed a normal sequence of segmental contribution, which was not the case in the ACD group. This cohort will now be asked to participate in the long-term follow-up study assessing the motion patterns 6-13 years after ACD or ACDA surgery. Intervention: One flexion and extension cinematographic recording of the cervical spine and will be made. Main study parameters/endpoints: The sequence of segmental contributions in sagittal rotation during flexion and extension of the cervical spine will be assessed in the long-term follow-up of surgical treatment. Secondary outcomes will be to assess the amount of degeneration based on the Kellgren Score (KS) and the segmental range of motion (sROM). Long term clinical outcomes will be assessed according to VAS, NDI, SF-36 and Odom's criteria. Patients will be asked whether they have new neurological symptoms and whether they have had a re-operation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants receive cinematographic recordings once. The amount of radiation is a negligible risk. There will be no health benefits. There will be no follow-up.

Start: September 2021

Posterior Cervical Study

The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported outcomes (PROs).This study is being undertaken to identify possible residual risks and to clarify mid-to long-term clinical performance that may affect the benefit/risk ratio of posterior fixation systems.

Start: March 2021

Activity Monitors as a Measure of Physical Function in Degenerative Cervical Myelopathy

The investigators objective of this research is to compare activity monitor results with standard of care (SOC) question-based outcome measures for degenerative cervical myelopathy patients before and after treatment with decompression. Understanding of the relationship between activity monitor data and question-based outcome measures in the context of degenerative cervical myelopathy will improve our understanding of the disease and limit the effort to diagnose and monitor it.

Start: August 2018

Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion

This research study is being conducted to help improve the pre-operative, intra-operative, and post-operative course for patients and enhance recovery.

Start: October 2020

The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy

The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.

Start: September 2014

CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes

The study will consist of two parts: In Study A, objectively assessed physical activity, gait, balance, range of movement of specific joints during walking and neurophysiological findings between patients with cervical spine stenosis (CSS) without myelopathy who will be treated conservatively and patients with stenosis and signs of myelopathy who are candidates for surgical Treatment will be compared. In Study B, the 6-month changes in the same outcomes in patients treated conservatively (from the first specialist consultation until 6 months later) and in patients treated surgically (preoperative day and 6-month post-operatively) will be quantified.

Start: September 2019

Motion Analysis of the Myelopathy Hand: New Insight Into the Classical Sign

This study aims to quantify the clumsiness and decreased dexterity seen in the grip and release test using a simple glove with sensors that can quantify the abnormal motion of this classical sign. This new tool will give a mechanistic insight into the myelopathy. The findings of this study will also form the basis of a prospective longitudinal study with clinical and radiological evaluation to compare the prognosticating value of this new information in clinical practice.

Start: July 2017

The Collar Post Anterior Cervical Spine Surgery Study

The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position. Our randomized trial comparing the impact of 6 weeks of post-operative bracing with a rigid cervical collar vs. no post-operative bracing, on a variety of clinical and radiological outcomes, for adult patients with cervical radiculopathy and/or myelopathy undergoing single or multi-level ACDF.

Start: February 2018

Prognostic Value of DTI and fMRI of Cervical Myelopathy

Cervical myelopathy (CM) is one of the most common degenerative spinal cord disorders affecting older people. The progression of CM is insidious and the neurological decline can vary between patients. Surgical decompression is considered the most effective way to treat CM, however, it is not free from risk and the surgical outcome is not always satisfactory. The expected outcome of surgical intervention for CM remains a difficulty. There is a pressing need for a reliable and quantitative approach to predict surgical outcomes of CM and the precise prognosis. Previous studies have suggested a number of prognostic factors, such as age, duration of symptoms, pre-operative neurological status and abnormal MRI, but their prognostic value remains controversial. Recently, diffusion tensor imaging (DTI) and fMRI have been proposed as a promising tool for predicting the surgical prognosis of CM. In previous study, the protocol was successfully established for DTI microstructural characterization and resting state fMRI of the cervical spinal cord. This study is to evaluate the value of DTI and fMRI in predicting the outcome of surgical treatment. The ultimate goal is to establish a clinical protocol for quantitative DTI and fMRI analysis that could give accurate prognosis for surgical intervention to CM.

Start: September 2018