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Spinal Deformity clinical trials

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NCT ID: NCT05566119 Active, not recruiting - Spinal Deformity Clinical Trials

L5-S1 Disc Fate in Thoracolumbar Arthrodesis Stopping at L5

L5S1OTLSF
Start date: August 12, 2022
Phase:
Study type: Observational

Spinal deformity in adults is one of the most frequently treated pathologies in spinal surgery. Their surgical treatment remains a challenge. In particular, the choice of the borderline vertebrae for thoracolumbar fusion correction remains controversial, including the choice between an instrumented last vertebra at L5 and an arthrodesis extending to the pelvis. Studies and meta-analyses show that an ilio-sacral socket provides better correction of pelvic parameters and avoids the development of distal junctional syndrome. On the other hand, there is more proximal junctional syndrome in patients fixed to the sacrum, and the sacral socket exposes patients to the risk of pseudarthrosis of the L5-S1 level and failure of the fixation hardware. Moreover, although this factor is not described in the studies, it would seem that an ilio-sacral socket is more stiffening. Overall, no study has shown a statistically significant difference in clinical scores between patients whose last instrumented vertebra is L5 and those with pelvic fixation. One of the theoretical risks of an extended fixation with a proximal thoracic grasp is to observe a premature disc degeneration of the L5-S1 disc since it would be subjected to more stress. This degeneration could be the cause of distal junctional syndrome and lumbo-radiculalgia due to inflammatory disc disease and disco-radicular impingement. However, to Investigator's knowledge, no clinical study has yet investigated the medium- and long-term fate of the L5-S1 disc in patients with extended fusion correction of a thoracic vertebra to L5. Investigator's team has sometimes favored a final instrumented vertebra at L5 when possible, i.e., when the L5-S1 disc was considered to be minimally or not degenerative and when its horizontality could be obtained after correction of the underlying curvature. Investigators therefore have a cohort of patients who have undergone this technique. The usual follow-up of these patients includes a consultation appointment every 2 to 5 years and a control MRI at a distance of more than 5 years: investigators thus have a control MRI and the clinical score of the patients. Investigator's objective is to determine whether there is degeneration of the L5-S1 disc, using MRI imaging data, which has never been published to investigator's knowledge.

NCT ID: NCT05452057 Recruiting - Spinal Deformity Clinical Trials

Prehab for Adult Spinal Deformity Surgery

Start date: March 24, 2022
Phase: N/A
Study type: Interventional

Prehabilitation is defined as the process of enhancing patients' functional capacity and overall fitness to enable them to withstand a forthcoming stressor (e.g. surgery). Although there are different models of prehabilitation, multimodal prehabilitation is recommended to address the physical and psychological health outcomes prior to surgery. Multimodal prehabilitation commonly consists of exercise-training, nutritional, and psychological support. Evidence suggests that prehabilitation improves preoperative physical fitness and reduces postoperative complications and length of stay in patients undergoing major abdominal surgery. However, the evidence for the feasibility and effects in spinal deformity surgery are less understood. This study is a two arm, pilot randomized controlled trial to assess the feasibility of a multimodal prehabilitation program prior to surgery for spinal deformity in adults. Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week preoperatively, and at 30 days postoperatively.

NCT ID: NCT05433545 Recruiting - Spinal Deformity Clinical Trials

Adherence to Physiotherapy Scoliosis Specific Exercises in Adolescents With Spine Deformity: Development of a New Questionnaire

Start date: March 22, 2022
Phase:
Study type: Observational

This study aims to develop a new instrument capable of providing an efficient measure of the quality and quantity of adherence to Physiotherapy Scoliosis Specific Exercises performed at home by growing patients with spinal deformity undergoing conservative treatment at a specialized institution. The development of a questionnaire in a Rasch environment and specifically developed for this population will ensure greater sensitivity and specificity of the questionnaire.

NCT ID: NCT05323448 Recruiting - Spinal Fusion Clinical Trials

Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.

Start date: October 25, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.

NCT ID: NCT05239962 Completed - Spinal Deformity Clinical Trials

A Reliability And Validity Study Of The Urdu Version Of Spine Functional Index.

Start date: May 30, 2021
Phase:
Study type: Observational

The Aim of the study is to translate Spine Functional Index scale into Urdu Language and to investigate the validity and reliability in Pakistan with the populace of Spinal disorders. Also checks its co-relation with Neck disability Index and Roland-Morris Disability Questionnaire.

NCT ID: NCT05170815 Recruiting - Spinal Deformity Clinical Trials

Clariance ErYs Registry

ErYs
Start date: January 17, 2022
Phase:
Study type: Observational

International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.

NCT ID: NCT05146193 Recruiting - Spinal Deformity Clinical Trials

AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations

Start date: May 1, 2022
Phase:
Study type: Observational

The investigators aim to use artificial intelligence (AI) to help clinicians in diagnosing and assessing spinal deformities.

NCT ID: NCT05108948 Recruiting - Spinal Deformity Clinical Trials

Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)

COFTASD
Start date: October 23, 2021
Phase:
Study type: Observational

The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.

NCT ID: NCT05001893 Active, not recruiting - Spinal Deformity Clinical Trials

Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery

Start date: May 3, 2021
Phase:
Study type: Observational [Patient Registry]

A retrospective, single-tertiary centre observational study. The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of Orthopaedics and Traumatology in the Turku University Hospital. Also, patients with non-instrumented posterolateral spine fusion, interbody spine fusion, and a combination of posterolateral and interbody spine fusion are included. The approximate number of the above-mentioned operations with BonAlive® putty is 400 - 500 between September 2013 and April 2021. In the operations, the BonAlive® putty was used either alone, together with autologous bone (AB) chips, with milled allogenous bone chips, with demineralized bone matrix (DBM), with other synthetic bone grafts, or with a combination of the above-mentioned.

NCT ID: NCT04899297 Recruiting - Quality of Life Clinical Trials

Quality of Life in Parents of Adolescents With Spinal Deformities: Development of a New Questionnaire.

Start date: May 7, 2021
Phase:
Study type: Observational

This study aims to develop a new instrument capable of providing an efficient measure of the quality of life of parents of conservatively treated patients with spinal deformity. The development of a questionnaire in a Rasch environment and specifically developed for parents of conservatively treated patients will ensure greater sensitivity and specificity of the questionnaire.