Clinical Research Directory

Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels

This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of Cervical Spine 2 to Thoracic 1 (C2-T1) and diagnosed with degenerative disc disease will be screened for the study.

Assessment of Upper Extremity Proprioception in Patients With Cervical Radiculopathy

There is no study in the current literature that systematically investigates the extent of upper-extremity proprioceptive impairment in patients with radicular neuropathic symptoms secondary to cervical disc herniation, nor its association with clinical findings. Although existing reviews emphasize proprioceptive deficits in populations with neck pain or cervical spondylosis, no studies specifically address the subgroup of cervical disc-related radiculopathy. This gap in knowledge hinders the integration of proprioceptive assessments with upper-extremity functional outcome measures in diagnostic and rehabilitative processes, suggesting a need for more specific data to guide sensory-motor training approaches. The primary aim of the present study is to assess upper-extremity proprioception in patients with cervical radiculopathy by comparing them with a healthy control group. The secondary aim is to examine the relationship between upper-extremity proprioception and clinical outcomes, including parameters such as pain and functional status.

Postoperative Analgesic Efficacy of SPSIPB in Anterior Cervical Discectomy

Anterior cervical discectomy is an operation performed for complaints of pain, numbness or loss of strength due to cervical disc disease. With this operation, pressure due to herniation on the upper neck area, spinal cord or nerve roots is relieved. It is performed by microscopic method from the front of the neck. Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications. In this study; it was aimed to compare the analgesic effectiveness of serratus posterior superior intercostal plane block and erector spinae plane block, and with the control group in the postoperative period in patients who underwent anterior cervical discectomy.

Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

This study will comprehensively evaluate the outcomes and endpoints of these two different FDA-approved artificial disc implants used to treat cervical spondylotic myelopathy and/or radiculopathy today: Biomet Zimmer Mobi-C and Nuvasive Simplify. Both implants are structurally different with the Nuvasive Simplify implementing a three-piece design with two endplates and a semi-constrained mobile core while the Biomet Zimmer Mobi-C implements an unconstrained three piece design. Subjects will be age-matched and randomly assigned to either implant with informed consent. All subjects will undergo a variety of assessments that evaluate neck disability, quality of life, pain, physiological outcome (radiographic assessments), and neck range-of motion before and after their procedure. One baseline testing will be conducted along with three post-operation visits (three months, six months, and one year) in accordance to standard follow-up procedure. Thus, the duration of participation in the study will be approximately one and a half years.

Smartwatch Accuracy for Measuring Vitals and Anxiety Before Disc Surgery

This study aims to verify the accuracy of blood pressure, heart rate, blood oxygen saturation, anxiety level, and sleep cycle data measurements obtained from Samsung smartwatches compared to the currently accepted method used in patients with disc herniation undergoing the preoperative period.

NuVasive® ACP System Study

The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).

Sensory and Functional Impairments in Cervical Disc Herniation

The aim of the study was to evaluate the levels of somatosensory perception, pain threshold and kinesiophobia in individuals with SDH, to examine their relationship with upper extremity functional skills and to compare them with healthy individuals.

M6-C Post Approval Study (PAS)

The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.

Functional Outcome After Surgery for Cervical Disc Prolapse

Cervical disc herniation (CDH) is the result of the displacement of the nucleus pulposus of the intervertebral disc, which may result in impingement of the traversing nerves as they exit the neural foramen or directly compressing the spinal cord contained within the spinal canal.\[1\] Eventually symptoms may arise because of a CDH with compression of the rootlet or spinal cord.\[2\] When conservative treatment for CDH fails, surgical treatment may be considered.\[3\] The main goals of surgical treatment are to remove pressure from the nerves, restore the alignment of the vertebrae, to stabilize the spine \[3\] and to prevent progression of neurological deficit in case of myelopathy.\[4\] Anterior cervical discectomy and fusion (ACDF) has proven to be an effective surgical intervention for both cervical radiculopathy and myelopathy and has become standard treatment for both of these disease states over the last half century.\[5\] Certain reports have indicated that various complications are associated with ACDF namely, incomplete decompression, recurrence of myelopathy due to adjacent segment degeneration.\[6\] In cases where the stenosis is extensive, or attributed in part to congenital stenosis, the posterior approach may be advantageous to achieve more extensive decompression that would otherwise not be possible through an anterior approach.\[7\] Given that most stenosis occurs from anterior pathology, a posterior decompression works to indirectly relieve pressure on the spinal cord.\[8\] Misalignment and large anterior compression of the spinal cord can be risk factors for insufficient functional recovery in patients treated with posterior decompression alone.\[9\] In this study we will perform ACDF for patients with CDH occupying less than 50% of cervical canal and combined posterior laminectomy and ACDF for patients with CDH occupying 50% or more of the cervical canal with canal stenosis.Cervical disc herniation (CDH) is the result of the displacement of the nucleus pulposus of the intervertebral disc, which may result in impingement of the traversing nerves as they exit the neural foramen or directly compressing the spinal cord contained within the spinal canal.\[1\] Eventually symptoms may arise because of a CDH with compression of the rootlet or spinal cord.\[2\] When conservative treatment for CDH fails, surgical treatment may be considered.\[3\] The main goals of surgical treatment are to remove pressure from the nerves, restore the alignment of the vertebrae, to stabilize the spine \[3\] and to prevent progression of neurological deficit in case of myelopathy.\[4\] Anterior cervical discectomy and fusion (ACDF) has proven to be an effective surgical intervention for both cervical radiculopathy and myelopathy and has become standard treatment for both of these disease states over the last half century.\[5\] Certain reports have indicated that various complications are associated with ACDF namely, incomplete decompression, recurrence of myelopathy due to adjacent segment degeneration.\[6\] In cases where the stenosis is extensive, or attributed in part to congenital stenosis, the posterior approach may be advantageous to achieve more extensive decompression that would otherwise not be possible through an anterior approach.\[7\] Given that most stenosis occurs from anterior pathology, a posterior decompression works to indirectly relieve pressure on the spinal cord.\[8\] Misalignment and large anterior compression of the spinal cord can be risk factors for insufficient functional recovery in patients treated with posterior decompression alone.\[9\] In this study we will perform ACDF for patients with CDH occupying less than 50% of cervical canal and combined posterior laminectomy and ACDF for patients with CDH occupying 50% or more of the cervical canal with canal stenosis. the aim of the study to Assessment of the functional outcome after surgery for cervical disc prolapse

The Effect of Tendon Release Techniques in Patients With Cervical Disc Herniation

The goal of this clinical trial is to investigate the effect of using enhanced golgi tendon organ stimulation on symptoms in patients with cervical disc herniation. The main question\[s\] it aims to answer are: * Enhanced Golgi tendon organ stimulation is effective in reducing symptoms in patients with cervical disc herniation. * Enhanced golgi tendon organ stimulation is not effective in reducing symptoms in patients with cervical disc herniation. Participants will receive enhanced golgi tendon organ stimulation to the Sternocleidomastoideus, platysma, longus colli, longus capitis, scalene, rhomboid major \& minor, levator scapulae and trapezius muscles for 3 weeks, 2 sessions per week for 45 minutes.

Cervical Arthroplasty Cost Effectiveness Study (CACES)

To date, no consensus exists on which anterior surgical technique is more cost-effective to treat cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multilevel symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). It remains unknown to what extent kinematics, surgery-induced fusion and natural history of disease play a role in its development. Anterior cervical discectomy with arthroplasty (ACDA) is thought to reduce the incidence of CASP by preserving motion in the operated segment. ACDA is often discouraged as the implant costs are higher whilst the clinical outcomes are similar to ACDF. However, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long-term. In this randomized controlled trial patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months till 4 years postoperatively. High quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking, to date no prospective trials from a societal perspective exist. Considering the ageing of the population and the rising healthcare costs, the need for a solid clinical cost-effectiveness trial addressing this question is high.