Minimal Invasive Scoliosis or Open Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- The primary outcome measure is the assessment of a composite group of variables by the statistical method of "win odds". The variables are listed in hierarchic order in the "description" below.
研究概览
简要总结
Surgical treatment for idiopathic scoliosis usually involves open surgery from the back (posterior approach). This method corrects the curve and stabilizes the spine using screws and rods, followed by a fusion of the treated segments. The goal is to achieve the best possible alignment of the spine.
This type of surgery can be demanding for the body and often requires a longer hospital stay because of tissue damage and pain after the procedure. Traditionally, patients stayed in the hospital for up to a week or more.
In recent years, recovery programs such as ERAS (Enhanced Recovery After Surgery) have been introduced. These programs include better pain control, faster mobilization, and improved preparation before surgery. Thanks to these improvements, many patients can now go home one to two days after surgery instead of several days.
There has also been a development of minimally invasive surgery (MIS) techniques in spine surgery. These techniques aim to reduce tissue damage and blood loss compared to traditional open surgery. Smaller incisions can lead to less scarring, less pain, and potentially faster recovery. Because scoliosis surgery is complex, it is important to study whether MIS offers the same safety and benefits as traditional surgery.
Minimally invasive surgery makes correct screw placement in the curved spine more challenging, as the usual anatomical landmarks are not fully exposed. To ensure accuracy, MIS often uses advanced technologies such as intraoperative 3D imaging or robotic-assisted surgery (RAS).
The purpose of this project is to evaluate whether MIS is as safe and effective as traditional open surgery. The study will compare both methods regarding the need for additional surgery, complications, infections, pain, and bone fusion after surgery. It will also examine hospital stay, degree of curve correction, accuracy of screw placement, changes in nerve function during surgery, blood loss, operation time, and patient-reported outcomes.
Most existing studies on MIS in scoliosis are based on older or small patient series, and randomized controlled trials are lacking. This research will provide scientific evidence to guide future treatment choices. The aim is to determine whether MIS can deliver the same correction and safety as open surgery while reducing pain, blood loss, and recovery time. If proven effective, these techniques could improve recovery and quality of life for many scoliosis patients.
详细描述
- Purpose and Aims:
The primary aim of this study is to evaluate the effectiveness of minimally invasive surgery (MIS) compared to traditional open surgery for the treatment of idiopathic scoliosis. While open surgery remains the gold standard for spinal correction, it is associated with significant tissue trauma, extended hospitalization, and postoperative pain. The emergence of MIS techniques offers potential benefits, including reduced tissue damage, shorter hospital stays, and faster recovery. However, the long-term outcomes and efficacy of MIS in scoliosis correction remain unclear due to the lack of high-quality evidence, particularly from randomized controlled trials (RCTs).
This study is designed as a multi-center, two-arm, non-inferiority RCT to determine whether MIS can achieve comparable outcomes to open surgery in terms of:
- Primary surgical outcomes: Reoperation rates, serious complications, surgical site infections, postoperative pain levels, and fusion success.
- Secondary measures: Hospitalization duration, screw placement accuracy, neurophysiological events, blood loss, operative time, and patient-reported outcomes (PROMs).
A key challenge in MIS is the accurate placement of implants in the deformed spine while minimizing disruption to surrounding tissues. The study will assess whether the use of intraoperative 3D imaging and robotic-assisted surgery (RAS) enhances precision while maintaining surgical success.
By addressing these critical questions, this trial aims to provide high-quality evidence on the role of MIS in scoliosis treatment. If MIS proves to be as effective as open surgery while offering faster recovery and fewer complications, it could lead to a paradigm shift in scoliosis management, improving patient care and reducing healthcare burden. 2. Background:
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
- Double (Participant, Outcomes Assessor)
盲法说明
The study design does not allow blinding of the surgeons and other personnel in the operating theatre. However, the patient and other health-care personnel will be blinded and held up to six months postoperatively. Patient reported outcomes will be assessed without influence of the caregiver.
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Idiopathic scoliosis
- •Age between 10-25 years
- •Planed surgery: Posterior correction for scoliosis
- •Major curve Cobb angle 75 degrees or less
排除标准
- •Inability to give informed consent
- •Other diagnosis of scoliosis than "idiopathic"
- •Rigid curves that require posterior or three-column osteotomy/ies
- •Previous surgery at the operated levels
- •BMI > 35
- •Psychological factors that make the patient unsuitable for inclusion in the study (e.g., substance abuse, developmental disability)
结局指标
主要结局
The primary outcome measure is the assessment of a composite group of variables by the statistical method of "win odds". The variables are listed in hierarchic order in the "description" below.
时间窗: From the inclusion of the first subject up to two years after the operation of the last subject.
The composite primary endpoint includes: (i) no reoperation within two years (defined as any secondary spinal procedure related to the index operation); (ii) no serious complications, defined as life-threatening events or complications associated with long-term disability; (iii) absence of early surgical site infection, defined as infections occurring within 12 weeks postoperatively; (iv) absence of other inpatient-related infections, such as pneumonia or urinary tract infections; (v) patient-reported pain at two years, measured using the Numeric Rating Scale (NRS) for back and leg pain; (vi) quality of life assessed with the SRS-22r questionnaire, which captures dimensions such as pain, function, self-image, mental health, and satisfaction; and (vii) radiological evidence of successful spinal fusion, defined as bone bridging across the operated spinal levels, either through the facet joints or between vertebral bodies.
次要结局
- Inpatient stay(During the discharge of each subject, assessed up to two weeks after the operation of the last subject.)
- Deformity correction rate(The assessment will take place during the first follow up of each subject (three months postoperatively) and will be assessed up to the first follow-up of the last subject.)
- Progression of Cobb angle in the operated levels at 2-years standing x-ray(At 2-year follow-up for each subject assessed up to the 2-year follow-up of the last subject.)
- Progression of secondary curve angles at 2-years standing x-ray(During the 2-year follow-up for each subject up to the 2-year follow-up of the last subject.)
- Perioperative blood loss(Assessed during the surgery of each subject)
- Accuracy of screw placement at the first attempt(Assessed during the surgery of each subject.)
- Total procedure time(From the start until the end of surgery for each subject.)
- Intraoperative neurophysiological monitoring(During the surgery of each subject.)
- Health economics(From the discharge of the first subject up to two years from the discharge of the last subject)
- SRS-22r(Patient reported outcome measure (PROM) registered in Swespine registry or similar platforms 1, 2, 5 and 10 years postoperatively.)
- EOSQ-24(Patient reported outcome measure (PROM) registered in Swespine registry or similar platforms 1, 2, 5 and 10 years postoperatively.)
- Oswestry Disability index (ODI)(Patient reported outcome measure (PROM) registered in Swespine registry or similar platforms 1, 2, 5 and 10 years postoperatively.)
- EQ-5D 3 level(Patient reported outcome measure (PROM) registered in Swespine registry or similar platforms 1, 2, 5 and 10 years postoperatively.)
- Postoperative pain relief(The information will be given by each subject at discharge as well as registered in Swespine registry or similar platforms 1, 2, 5 and 10 years postoperatively.)