Posterior Column Spinal Osteotomies in the Treatment of Adolescent Idiopathic Scoliosis. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Scoliosis correction
研究概览
简要总结
Background: Posterior column osteotomies (PCO) are routinely used to facilitate curve correction in surgical treatment of adolescent idiopathic scoliosis (AIS). Data regarding routine use of PCO is controversial, with conflicting data for coronal and sagittal plane correction and clinical benefit. Use of PCO has not been studied in the surgical treatment of AIS in a prospective randomized clinical trial.
Study Design: A randomized, multicenter clinical trial on children and adolescents undergoing posterior spinal fusion for idiopathic scoliosis using pedicle screw instrumentation. Sixty consecutive adolescents will be randomized into PCO or no PCO group after surgical exposure of the spine in 1:1 ratio.
Aims and Hypothesis: To compare PCO vs. no PCO groups for the correction of coronal and sagittal plane curve in children undergoing posterior spinal fusion for AIS. The investigators hypothesize that the correction of coronal curve and hypokyphosis will be better in PCO group without increasing blood loss or complications.
Inclusion criteria: Adolescents (aged 10 to 21 years of age) undergoing corrective surgery for idiopathic scoliosis using pedicle screw technique.
Exclusion criteria: Coagulation disorder, smoking, unwilling to consent, vertebral column resection, need for anteroposterior surgery.
Main outcome parameters: Primary outcome is the radiographic correction (Coronal and sagittal plane). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain, rib hump, operative time, blood loss, hospital stay, and complications.
Ethical aspects: Ethical committee approval will be obtained. An informed consent will be obtained from all children and their parents.
Time schedule and budget: This study has ethical committee approval.There will be no extra costs as all information gathered will be part of normal surgical treatment of AIS. A part-time research nurse has been hired to take care of data collection into the database.
详细描述
Background AIS is the most common indication for major surgery in adolescents. The current standard of care for idiopathic scoliosis with a curve magnitude of over 40-50˚ is posterior spinal fusion (PSF) with pedicle screw fixation. Pedicle screws are implanted using posterior subperiostal approach into pedicles and vertebral bodies and the screws are then connected with longitudinal rods to allow correction of scoliosis. Spinal fusion is obtained by local bone graft on decorticated posterior spinal elements. 70% correction of scoliosis is expected with standard PSF surgery for idiopathic scoliosis (1).
Posterior osteotomies are used to facilitate correction of scoliosis during PSF. Concept of PCO was originally introduced in 1945 for treatment of spinal deformities in patients with rheumatoid arthritis and ankylosing spondylitis (2). Indications for use of PCO have later broadened to surgical correction of Scheuermann´s kyphosis and idiopathic scoliosis (3). Currently, the most commonly used technique was described by Ponte (4). In Ponte osteotomy a wide resection of the thoracic facet joints, laminae, and ligamentum flavum is conducted to generate a 5-10 mm posterior gap that closes with segmental instrumentation (4). Originally these osteotomies were utilized to correct hyperkyphotic deformities allowing approximately a 10-degree correction per spinal level (5). In AIS increase of curve correction up to 7%, and 15% correction of rip hump has been described with PCO (6). Up to 15% critical neuromonitoring changes have been observed in patients undergoing PCO (7). Although there is enhanced correction of the curve in AIS, no differences have been observed in patient reported outcome measures (PROM) (8). PCO is currently used to facilitate correction of AIS with reported enhancement of coronal and axial parameters. There are not any Level 1 studies evaluating the feasibility of PCO in the surgical treatment of AIS.
Aims and hypothesis To compare postoperative scoliosis, kyphosis, rib hump, hemoglobin and hematocrit decrease, length of hospital stay and complications in patients having PCO or not having PCO during posterior spinal fusion for AIS. The investigators hypothesize that patients with PCO have better correction of scoliosis with similar blood loss and complications.
Methods Study design - A randomized, clinical trial according to CONSORT criteria (9).
Patients - 60 adolescents undergoing posterior spinal fusion with pedicle screw instrumentation for idiopathic scoliosis will be randomized after exposure of the spine for PCO. PCO will be conducted at three adjacent levels at the apex of the curve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not be informed of chosen treatment
入排标准
- 年龄范围
- 10 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent idiopathic scoliosis (Lenke 1 to 4)
- •Age at surgery between 10 and 21 years
- •Cobb angle of 45 degrees or more
- •Posterior spinal fusion
排除标准
- •Anteroposterior surgery
- •Vertebral column resection
- •Diabetes mellitus
- •Bleeding disorder
研究组 & 干预措施
Posterior column osteotomy
Apical 3-5 posterior column osteotomies in addition to standard treatment
干预措施: Posterior column osteotomy (Procedure)
No osteotomies
Standard treatment
干预措施: No osteotomies (Procedure)
结局指标
主要结局
Scoliosis correction
时间窗: 2 year follow-up
Cobb angle
Forced vital capacity
时间窗: 2 year follow-up
Lung volume
Kyphosis correction
时间窗: 2 year follow-up
Cobb angle
次要结局
- Opioid consumption(48 hours)
- SRS-24 total score(2 year follow-up)
研究者
Ilkka Helenius
Professor
Turku University Hospital
