Posterior Vertebral Column Resection (PVCR) for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Change in Scoliosis Research Society (SRS)-24 (arabic version) Health-related quality of life questionnaire
研究概览
简要总结
Congenital spinal deformities (CSD) are caused by early embryologic errors in vertebral column formation. Spinal cord malformations are present in approximately one third of patients, even associated cardiac, renal, and genitourinary organ system anomalies in more than half of patients. Functional activity and health-related quality of life (HRQOL) are severely affected in adolescents with neglected severe congenital kyphoscoliosis (CKS) progressive curves in developing countries.
Different strategies are described with two main principles; I- Prophylactic surgeries like hemi-epiphysiodesis or in situ fusions that will cease worsening or allow progressive correction over time, II- Corrective surgeries like reconstructive osteotomies and spinal fusion with or without spinal resection. The perfect show in management of congenital spinal deformities is to pick up the curves at early stages where a prophylactic treatment can be achieved with minimal risk to the spinal cord, but certainly many cases are quite aggressive or come late enough where corrective surgeries and even spinal column resection is the only valid plan.
A posterior-based vertebral column resection (VCR) is considered to be the preferred approach in the treatment of rigid, severe, and complex spinal deformities, however the difficult and lengthy nature of the procedure require assistance from experienced and well trained team. It is relatively safe but challenging technique, that allows for dramatic radiographic correction and clinical improvement. It also carries a complication rate of 10.2% as profound blood loss, iatrogenic neurological deficit and late junctional kyphosis.
详细描述
Preoperative Details :
Every patient is examined for 1- Shoulder balance 2- Pelvic balance 3- Thoracic hump 4- Neurological examination. Also preoperative whole-spine X-ray anteroposterior and lateral view radiographs in erect position are obtained for accurate preoperative planning. Three-dimensional Multi-Slice Computed Tomography (MSCT) scan is obtained to delineate posterior vertebral column pathoanatomy before surgery. Whole-spine MRI is obtained for declaration of any associated spinal cord malformation.
Operative Details :
Appropriate patient positioning on the operating frame to avoid excessive pressure points in the axilla, allow the abdomen to hang free, and to maintain stability of the trunk during surgery. Standard posterior exposure is performed, and pedicle screws are placed using a free-hand technique as. The exposure at the osteotomy site is extended laterally to resect a portion of the medial ribs to enhance the exposure of the vertebral body to be removed.
Once adequate exposure is achieved, a wide laminectomy is completed from the pedicles of the proximal vertebra to the pedicles of the distal vertebra. Use of tranexamic acid to minimize osseous bleeding during these lengthy surgeries is advisable. At this point, a short rod is placed into the pedicle screws of 1 side to include at least 2 pedicle screws proximally and 2 pedicle screws distally, to provide stability during the osteotomy. Once this rod is secured, the proximal and distal discs are removed and the vertebra to be removed is outlined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neglected congenital kyphoscoliotic spinal deformity
- •Thoracic and Lumbar curves only
- •Age more than 10 years old
排除标准
- •Cervical and Sacral deformities
- •Revision failed back surgeries
研究组 & 干预措施
Congenital Thoracolumbar Kyphoscoliosis
Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity by Posterior Vertebral Column Resection (PVCR) Surgical Technique
干预措施: Posterior Vertebral Column Resection (PVCR) (Procedure)
结局指标
主要结局
Change in Scoliosis Research Society (SRS)-24 (arabic version) Health-related quality of life questionnaire
时间窗: Baseline preoperative, then 3 months, and 1 year postoperative
The score of questionnaire components is used to assess how patients are doing regarding their function (day to day activities), their pain level (or hopefully improvement in/lack of), how they feel they look, how they feel about themselves, and if they are satisfied as the result of their treatment. Preoperative and postoperative scores are compared.
次要结局
- Short Form (SF)-36 Health Survey(Baseline preoperative, then 3 months, and 1 year postoperative)
- Lumbar Lordosis Angle (LLA)(Baseline preoperative, then 2 weeks, and 1 year postoperative)
- Sagittal Vertical Axis (SVA) to C7 Plumb Line (C7PL)(Baseline preoperative, then 2 weeks, and 1 year postoperative)
- Oswestry Disability Index (ODI)(Baseline preoperative, then 3 months, and 1 year postoperative)
- Complications Rate(Intraoperative, then Immediate, 2 weeks, 3 months, and 1 year postoperative)
- Local Kyphosis Angle (LKA)(Baseline preoperative, then 2 weeks, and 1 year postoperative)
- American Spinal Injury Association (ASIA) Score(Baseline preoperative, then immediate, and 3 months postoperative)
- Scoliosis Angle (Cobb's Angle)(Baseline preoperative, then 2 weeks, and 1 year postoperative)
- T1-S1 Trunk Height (TH)(Baseline preoperative, then 2 weeks, and 1 year postoperative)
- Thoracic Kyphosis Angle (TKA)(Baseline preoperative, then 2 weeks, and 1 year postoperative)
- Leg Length Discrepancy (LLD)(Baseline preoperative, then 1 year postoperative)
- CT-based Classification for assessment of biological graft fusion(1 year postoperative)
- Shoulder Balance (Clavicle Angle)(Baseline preoperative, then 2 weeks, and 1 year postoperative)
- Body Height (BH)(Baseline preoperative, then 2 weeks, and 1 year postoperative)
- Central Sacral Vertical Line (CSVL) to C7 Plumb Line (C7PL)(Baseline preoperative, then 2 weeks, and 1 year postoperative)
研究者
Muhammad Almessry
Principal investigator
Assiut University
