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Spine Deformity clinical trials

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NCT ID: NCT05038527 Recruiting - Adverse Events Clinical Trials

ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective trial is to investigate ABM/P-15 bone graft versus traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD) in order to provide better clinical results through faster bone healing, no additional surgeries, fewer complications and thereby increase health-related quality of life. Main hypotheses: 1. The use of ABM/P-15 bone graft is superior to traditional bone graft treatment regarding the incidence of additional surgeries following index surgery for ASD Secondary hypotheses: 2. The investigators expect non-inferiority in patient reported outcome measures in the ABM/P-15 bone graft group compared to the control group 3. The investigators expect non-inferiority in the postoperative fusion rates (bone healing) evaluated on CT scans in the ABM/P-15 bone graft group compared to the control group 4. The investigators expect non-inferiority in postoperative incidence of asymptomatic pseudarthrosis in the ABM/P-15 bone graft group compared to the control group 5. The investigators expect non-inferiority in perioperative complications in ABM/P-15 bone graft group compared to the control group 6. The investigators expect the use of ABM/P-15 bone graft to be cost-efficient compared to the traditional treatment in the control group

NCT ID: NCT04968483 Not yet recruiting - Spine Deformity Clinical Trials

Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity

Start date: September 1, 2021
Phase:
Study type: Observational

To investigate the nutritional status, nutritional support and postoperative complications of patients undergoing spinal orthopedic surgery during the perioperative period.

NCT ID: NCT04691258 Completed - Low Back Pain Clinical Trials

Back Squat Exercise Treatment for Low Back Pain: Clinical Trial

Start date: November 30, 2020
Phase: N/A
Study type: Interventional

Summary: Low back pain is the leading cause of deficiency and loss of productivity worldwide. No evidence of any particular exercise was more effective than another for treating nonspecific low back pain. Objective: To evaluate the efficacy of two resistance training protocols, with different techniques for performing lower limbs exercises, in improving vertebral posture and reducing symptoms of low back pain. Methods: Randomized parallel clinical trial with two arms: Restricted Group (GR) performed all squat and Stiff exercises with neutral vertebral posture and the Complete Group (CG) performed the same exercises prioritizing the complete range of motion. Both groups had a 12-week intervention with 36 resistance training sessions. This study was conducted between November 2020 and April 2021 in Goiás (Brazil). Thirty-two participants aged 18 to 69 years with nonspecific low back pain were recruited in the extension project of the Faculty of Physical Education and Dance of the Federal University of Goiás (UFG), at the Hospital das Clínicas - UFG and at the Campos Samambaia Health Center. To ensure blindness, participants did not know why the technique of movement between them was different. The movement technique was monitored by one teacher per participant throughout the training and cannot be altered by participants at risk of compromising the results. Spinal posture was evaluated by three-dimensional reconstruction and posture quantification using dynamic posture software and pain symptoms were evaluated by the Brief Pain Inventory and Rolland Morris Questionnaire. Statistical analysis was performed in the Software SPSS and MATLAB. The Shapiro-Wilk and Bartlett tests were used to confirm the normal distribution and similar variances in the distribution of the data. The other quantitative and qualitative variables were analyzed by nonparametric statistical methods. Quantitative data with normal distribution were reported by means of means and standard deviation, minimum and maximum values, and the other data by median, interquartile range, minimum and maximum values. The pre-intervention conditions of the groups were compared by independent t-test. Two-way ANOVAs (groups X time) were used for group intervention effect comparisons for quantitative data variables with normal distribution. Significance level of 5%. The size of the effect of the results will be calculated using cohen's test.

NCT ID: NCT04524377 Recruiting - Parkinson Disease Clinical Trials

Evaluation of the Influence of Deep Brain Stimulation on the Spinal Deformities Associated With Parkinson's Disease

Start date: July 25, 2019
Phase: N/A
Study type: Interventional

The intention of the study is to investigate whether Deep Brain Stimulation (DBS) will improve postural deformities of patients with Parkinson's disease.

NCT ID: NCT04241211 Enrolling by invitation - Spine Deformity Clinical Trials

Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial

Start date: January 1, 2014
Phase: Phase 4
Study type: Interventional

Medical therapy that can lower PJK rates are also being sought. Teriparatide (TP), a recombinant human parathyroid hormone (PTH 1-34), is a bone forming agent mainly used to treat osteoporotic patients with high risk of osteoporotic fracture. There has been reports suggesting protective effect of prophylactic TP to osteoporotic patients receiving ASD surgery concerning PJK.6 Although it had limitations of small sample size and surgical selection bias owing to study design being retrospective. We hypothesized prophylactic TP would act as to reduce the incidence of PJK and therefore reduce PJF and necessity of revision surgeries in patients after ASD correction surgery. Our study can consolidate the beneficial effect of prophylactic TP to patients receiving ASD surgery by reducing the incidence of PJK.

NCT ID: NCT03513757 Completed - Headache Clinical Trials

Dexmedetomidine and Propofol for Pediatric MRI Sedation

Start date: March 4, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol). The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. The investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, the investigators will administer whatever is necessary. At the end of the study, the investigators will have an observer record the time it takes for participants to spontaneously open eyes , to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that the investigators find out from participants about changes in behavior, or if eating or sleeping habits were unusual following completion of the study. For that reason, the investigators will call participants in a day or so following the MRI scan. The investigators expect to recruit 40 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018.

NCT ID: NCT02286102 Completed - Spine Deformity Clinical Trials

A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

Start date: January 2011
Phase: N/A
Study type: Interventional

The examination of the ability of the OrthoPAT® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or more.