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Spinal Diseases clinical trials

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NCT ID: NCT06115512 Recruiting - Clinical trials for Degenerative Disc Disease

A Phase 3 Study of AGA111 in Patients With Degenerative Disc Disease Undergoing Lumbar Interbody Fusion

Start date: December 8, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the overall efficacy of a single intervertebral local administration of AGA111 in patients with degenerative disc disease undergoing lumbar interbody fusion.

NCT ID: NCT06030570 Recruiting - Low Back Pain Clinical Trials

Effect of an Interdisciplinary Spine Rehabilitation Program

PROGRESS
Start date: August 22, 2023
Phase:
Study type: Observational

The goal of this research project is to evaluate the effectiveness of the current interdisciplinary rehabilitation program (Revita) and follow-up trajectory for chronic lumbar spine disorders in the University Hospitals Leuven.

NCT ID: NCT06014632 Recruiting - Clinical trials for Lumbar Spine Disease

Efficacy of Motor Control Exercise Program After Lumbar Spinal Decompression Surgery

Start date: June 12, 2023
Phase: N/A
Study type: Interventional

The study will be conducted with volunteer patients who have undergone lumbar decompression surgery and who are followed up by the Neurosurgery outpatient clinic of Fethiye State Hospital. The cases will be divided into 2 groups by randomization software. The control group will receive stretching, strengthening, core stabilization and educational content as usual care 3 months post-operatively. The study group will be given motion control exercises in addition to the program given to the control group 3 months post-operatively. These applications will be applied to the patients face-to-face in the clinical environment 2 days a week for 12 weeks. The first evaluation will be performed 3 months post-operatively before the treatment and the second evaluation will be performed 3 months after the treatment.

NCT ID: NCT05947175 Recruiting - Clinical trials for Degenerative Spine Diseases

Vertebral Bone Marrow Clot for Spinal Surgery

Start date: May 19, 2023
Phase: N/A
Study type: Interventional

Spinal fusion (SF) is a common orthopedic procedure to treat spinal diseases. Apart from fixation systems, the procedure requires bone grafting to further improve SF. Cell-based therapies as vertebral bone marrow aspirate (vBMA) with bone allograft were developed as alternative to bone autograft in SF. However, vBMA use is limited by the lack of a standardized procedure, of a structural texture and by the possibility of diffusion away from the implant site. Recently, the potential use of a new formulation of vBMA, named vBMA clot, has been described. The project aims at evaluating the clinical evidence and the biological features of vBMA clot associated to bone allograft for SF surgery, considering age and gender related differences. A randomized controlled trial will prove the efficacy of the treatment and advanced preclinical studies will improve the knowledge on vBMA clot regenerative and anti-inflammatory properties, exploring for the first time its antibacterial characteristics.

NCT ID: NCT05944393 Recruiting - Scoliosis Clinical Trials

Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery

Start date: September 8, 2022
Phase: N/A
Study type: Interventional

Postoperative pain after scoliosis correction surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options are limited and include intrathecal opioids and epidural analgesia. However, they are rarely used due to side effects and inconsistent efficacy. The investigators describe an opioid-sparing multimodal analgesia regimen with bilateral erector spinae plane blocks.

NCT ID: NCT05889611 Recruiting - Spine Disease Clinical Trials

Iterative Endotracheal Tube Cuff Pressure Monitoring

SIPBIE
Start date: March 22, 2023
Phase:
Study type: Observational

Studies in the medical literature underline the importance of monitoring the pressure of the balloon and the relationship with the incidence cited on the pain and discomfort related to the gesture of the upper airways. There are no formal recommendations in the literature, the French Society of Anesthesia and Resuscitation (SFAR) recommends monitoring the pressure intraoperatively except after intubation. It would be interesting to see and thus make an inventory of the practices, to reiterate the importance of monitoring throughout the gesture and at the change of position to avoid either micro-inhalation linked to under pressure of the balloon or overpressure which causes a potential risk of tracheal injury.

NCT ID: NCT05740176 Recruiting - Clinical trials for Cervical Degenerative Disc Disease

The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

A multicenter, prospective, non-randomized, historically controlled study. To demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months.

NCT ID: NCT05709782 Recruiting - Spinal Disease Clinical Trials

Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC

Start date: May 9, 2023
Phase: Phase 2
Study type: Interventional

To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.

NCT ID: NCT05615597 Recruiting - Low Back Pain Clinical Trials

Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease

IPAD
Start date: December 22, 2022
Phase: N/A
Study type: Interventional

Degenerative disc disease (DDD) is a major cause of chronic low back pain (> 40%). It can be defined by specific magnetic resonance imaging (MRI) features, with a strong correlation between pain and the inflammatory aspect of the disc, resulting in active disc disease (AD). The Modic classification based on MRI of the lumbar spine is considered a reference. The management of low back pain in patients with inflammatory disc disease generally involves intra-disc corticosteroid infiltration, which has been widely proven to be effective in reducing pain [4-6]. However, this procedure can be painful and invasive and sometimes impossible to perform due to severe disc impingement. The aim of this study is to evaluate the efficacy on pain of para-disc infiltration of corticosteroids in contact with the inflammatory MRI signal abnormality (Modic 1) when it is lateralized. This variant of infiltration is easier to perform (no catheterisation of the disc and therefore quicker), would entail less risk of disc infection and would be accessible to more radiologists. It is already practised but, to our knowledge, has never been the subject of a study to evaluate its effectiveness on pain. If successful, more patients could be treated and the range of treatment could be extended.

NCT ID: NCT05610098 Recruiting - Tuberculosis Clinical Trials

Gene Expression Profiles in Spinal Tuberculosis.

SpinalTBX
Start date: October 25, 2022
Phase:
Study type: Observational

Tuberculosis (TB) is one of the top ten causes of death worldwide with approximately 10 million cases globally and 1.2 million deaths. Sub-Saharan Africa carries the highest burden of TB. South Africa has one of the highest HIV and TB rates worldwide with an HIV prevalence rate in adults of 19% and a TB case notification rate of 615/100,000 in 2019. Over many years, focus has been paid to pulmonary TB and extrapulmonary TB (EPTB) has received only little attention even though it accounts for almost a quatre of all TB cases. The diagnosis of EPTB remains challenging simply because sample collection requires invasive procedures in the absence of a blood-based diagnostic test. Spinal TB (spondylitis or spondylodiscitis caused by Mycobacterium tuberculosis) - often known as Pott's disease - accounts for up to 10% of EPTB and affects young children, people with HIV-coinfection and elderly, and often leads to lifelong debilitating disease due to devastating deformation of the spine and compression of neural structures. Little is known with regards to the extent of disease and isolated TB spine as well as a disseminated form of TB spine have been described. The latter presents with a spinal manifestation plus disseminations to other organs such as the lungs, pleura, lymph nodes, the GIT or urinary tract or even the brain. In the Spinal TB X cohort, the investigators aim to describe the clinical phenotype of spinal TB using whole body PET/CT and identify a specific gene expression profile for the different stages of dissemination and compare findings to previously described signatures for latent and active pulmonary TB. A blood-based test for spinal TB would lead to earlier diagnosis and treatment in all settings globally and improve treatment outcome of this devastating disease.