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Scoliosis clinical trials

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NCT ID: NCT04420143 Completed - Clinical trials for Degenerative Disc Disease

MLX/XLX ACR Expandable Lumbar Interbody Implants

Start date: January 27, 2020
Phase:
Study type: Observational

The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiographic outcomes, and clinical patient outcomes. 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 ratios of the MLX and XLX ACR interbody implants.

NCT ID: NCT04418830 Enrolling by invitation - Clinical trials for Degenerative Disc Disease

Lumbar Interbody Implant Study

Start date: October 1, 2020
Phase:
Study type: Observational

The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and patient-reported outcomes. 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 ratios of these interbody implants.

NCT ID: NCT04418817 Completed - Clinical trials for Degenerative Disc Disease

Modulus in XLIF Study

Start date: March 22, 2020
Phase:
Study type: Observational

The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications, radiographic outcomes, and patient-reported outcomes.

NCT ID: NCT04403152 Completed - Clinical trials for Scoliosis Idiopathic

Postoperative Rehabilitation or Mobilization After Scoliosis Surgery

Start date: February 5, 2017
Phase: N/A
Study type: Interventional

Scoliosis surgery is a major surgery associated with postoperative pain, loss of physical function and pulmonary dysfunction in adolescent idiopathic scoliosis patients (AIS).Despite the advanced, various medical treatment methods of pain applied in the postoperative period, the mean period of hospitalization is 5 to 7 days. The increasing health expenditures over the years have brought along the need for rehabilitation programs conducted in the early term. Although early mobilization has been accepted as a rule of thumb by spinal surgeons in preventing the performance loss and reducing the causes of morbidity in recent years, the investigators could not find any research on postoperative rehabilitation implemented on patients under the supervision of a physiotherapist, following scoliosis surgery. The aim of this study was to compare effect of five days of intensive postoperative rehabilitation and mobilization on length of hospitalization and outcome in patients having scoliosis surgery.

NCT ID: NCT04382638 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Effectiveness of Three Dimensional Correction During in Bracing in Adolescent Idiopathic Scoliosis

Start date: July 2, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to study the effectiveness of in-brace 3D scoliosis correction by comparing Rigo Chêneau orthoses (RCO) with conventional Traditional Boston-style thoracolumbosacral orthoses (TLSO) in Adolescent Idiopathic Scoliosis (AIS) patients, following Scoliosis Research Society (SRS) and The International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) recommendations for non-operative AIS management and research studies. This group of patients that reach the threshold for bracing have an intrinsic higher risk for curve progression. Hence, the proposed study will provide novel and high quality evidence to improve the efficacy of bracing in the non-operative treatment of AIS. This will contribute significantly to the betterment of public health by reducing the number of patients requiring surgical intervention. Ultimately, new evidence-based clinical practice guidelines on the most effective type of scoliosis braces will benefit children diagnosed with AIS worldwide.

NCT ID: NCT04357561 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

The Effects of Scoliosis-Specific Exercises Before Surgery

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of scoliosis-specific exercises in adolescent idiopathic scoliosis patients, who had surgical indication, on functional capacity, cosmetic deformity perception, quality of life in postoperative period.

NCT ID: NCT04343170 Active, not recruiting - Clinical trials for Iron Deficiency Anemia

Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction

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

Scoliosis is a condition in which there is curvature of the spine occurring in the lateral plane. It occurs in structural forms, characterized by a fixed curve, and "functional" forms, characterized by a flexible or correctable curve. By anatomic necessity, this lateral deviation is associated with vertebral rotation, such that when this deformity occurs in the thoracic spine, a chest wall deformity, or "rib hump," develops. Often there is a primary structural curve with an adjacent secondary compensatory curve. Most cases of structural scoliosis are idiopathic and have their onset in early adolescence. Females are affected more often than males, and their curvature is more likely to worsen. Lumbar fusion surgery is usually associated with massive blood loss. In clinical practice the surgeon might measure the visible peri-operative bleeding including intra- and post-operative drainage, but ignore blood component penetration into the tissues, residual blood in vertebral canal and loss due to haemolysis, which are also known as hidden blood loss. In patients with adolescent idiopathic scoliosis (AIS), surgical treatment involves a posterior approach with multi-segmental pedicle screw fixation. Although this procedure is generally considered safe with few surgical complications, there are considerable variations in fusion length, surgical time, and the extent of soft-tissue exposure. Consequently, perioperative blood loss can be substantial, and the use of intraoperative and postoperative RBC transfusions are frequently required. Patient blood management (PBM) is an evidence-based, multidisciplinary approach developed over the last 10 years focusing on improving patient outcomes as well as reducing the use of RBC transfusions. PBM includes several preventive measures to manage bleeding risks, reduce iatrogenic blood loss, and modify decision thresholds for the appropriate administration of blood therapy. All patients for elective surgery in whom blood loss is expected to be > 500 ml should have their hemoglobin checked pre-operatively and be investigated if they are found to be anemic. In the general population, anemia is defined as a hemoglobin less than 130 g. in men and less than 120g. in women by the WHO. It was proposed that the cut-off value/trigger be changed to hemoglobin more than 130 g for both men and women. Women with hemoglobin levels between 120 and 129 g. are not considered to be anemic according to the WHO definition, leaving them at a potential disadvantage when undergoing major surgery

NCT ID: NCT04341831 Not yet recruiting - Clinical trials for Lumbar Spinal Stenosis

Does Teicoplanin Powder Use In Lumbar Instrumentation Surgery Reduce Surgical Site Infection

Start date: April 15, 2020
Phase: Phase 3
Study type: Interventional

Infection after spinal surgery is one of the serious complications. Spinal surgery infection can cause high morbidity, mortality, and costs. In spite of different prophylactic methods, up to 15% of infection appears after spinal surgery. Vancomycin powder, which is one of the most applied methods, seems to be effective and inexpensive. However, vancomycin administration may be inconvenient in elderly participants with high comorbidity and especially kidney problems. The investigators aimed to reduce the rate of infection in the post-op 90-day period by adding per-op Teicoplanin powder onto the implant in participants scheduled for lumbar posterior instrumentation.

NCT ID: NCT04336111 Recruiting - Analgesia Clinical Trials

Ultrasound Guided Bilateral Retrolaminar Block as Analgesia for Adolescent Idiopathic Scoliosis Correction

Start date: December 30, 2023
Phase: N/A
Study type: Interventional

Scoliosis is a structural, tridimensional deformity of the spine. Characterized by lateral curvature and rotation of the vertebrae with functional limitations and cosmetic problems, idiopathic scoliosis, which accounts for 75% to 80% of all scoliosis, is the most common of all types. (1, 2) Surgical treatment is an effective way to correct severe spine deformity when the deformity progressively worsens and cannot be positively corrected by brace treatment. Spinal correction surgery is one of the most invasive surgical procedures and usually results in moderate to severe levels of postoperative pain. (3) Severe pain may induce implant complications such as construct dislodgement, broken instrumentation, and implant loosening which requires additional revision procedures These conditions adversely affect postoperative outcomes.(4) In the past several years, pain has become an important indicator for evaluating indicators of outcome and quality of life after surgery. Effective analgesia after surgery could improve patients' prognosis.(5) The retrolaminar block is a recently described ultrasound-guided technique in which local anesthetics is injected into the fascial plane between the posterior surface of the thoracic lamina and the overlying transverso-spinalis muscles. (2) The available evidence indicates that retrolaminar block is effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics

NCT ID: NCT04336046 Recruiting - Analgesia Clinical Trials

Ultrasound Guided Bilateral Erector Spinae Block as Analgesia for Adolescent Idiopathic Scoliosis Correction

Start date: April 4, 2023
Phase: N/A
Study type: Interventional

Scoliosis is a structural, tridimensional deformity of the spine. Characterized by lateral curvature and rotation of the vertebrae with functional limitations and cosmetic problems, idiopathic scoliosis, which accounts for 75% to 80% of all scoliosis, is the most common of all types. (1, 2) Surgical treatment is an effective way to correct severe spine deformity when the deformity progressively worsens and cannot be positively corrected by brace treatment. Spinal correction surgery is one of the most invasive surgical procedures and usually results in moderate to severe levels of postoperative pain. (3) Severe pain may induce implant complications such as construct dislodgement, broken instrumentation, and implant loosening which requires additional revision procedures These conditions adversely affect postoperative outcomes.(4) In the past several years, pain has become an important indicator for evaluating indicators of outcome and quality of life after surgery. Effective analgesia after surgery could improve patients' prognosis.(5) The erector spinae block is a recently described ultrasound-guided technique in which local anesthetics is injected into a fascial plane between the tips of the thoracic transverse processes and the overlying erector spinae muscle (longissimus thoracis).(6) The available evidence indicates that erector spinae block is effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics