Minimal Invasive Scoliosis or Open Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-25
SponsorUppsala University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Idiopathic scoliosis
Age between 10-25 years
Planed surgery: Posterior correction for scoliosis
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Minimally invasive scoliosis surgery
Procedure/SurgeryPatients undergoing minimally invasive surgery have screws placed using the surgeon's preferred method: 3D navigation, robotic assistance, freehand, or combinations. A long incision of the skin is made without detaching the erector spinae muscles. Each screw is inserted through the musculature, and positioning is verified with intraoperative CT; misplaced screws are corrected. Rods are then shaped, placed, and deformity correction is performed. The surgeon may decorticate some or all facet joints using minimally invasive techniques before closing the wound.
Traditional open scoliosis surgery group
Procedure/SurgeryIn traditional open scoliosis surgery, the surgeon uses the preferred method for screw placement (3D navigation, robotic assistance, freehand, or combinations). A long incision is made, and the spinal musculature is detached to fully expose the posterior elements. All screws are inserted through this open area, and their positions are verified with intraoperative CT; misplacements are corrected if needed. Rods are shaped, placed, and deformity correction is performed. Decortication of facet joints, spinous processes, and laminae may be performed with a high-speed burr or similar technique. The wound is then closed.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Minimally invasive scoliosis surgery groupExperimental treatment 1 intervention
Group B: Open scoliosis surgery groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.
Time frame
From the inclusion of the first subject up to two years after the operation of the last subject.Secondary outcomes
1
Inpatient stay
Inpatient stay from the day of operation up to discharge measured in days
Time frame
During the discharge of each subject, assessed up to two weeks after the operation of the last subject.2
Deformity correction rate
The deformity correction rate will be assessed as Cobb-angle correction in a postoperative x-ray from the first standing radiograph compared to the last preoperative radiograph. The correction of the curve will be calculated according to the formula: (preoperative Cobb angle - postoperative Cobb angle) / (preoperative Cobb angle) × 100%.
Time frame
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.3
Progression of Cobb angle in the operated levels at 2-years standing x-ray
Progression of Cobb angle in the operated levels at 2-years standing x-ray compared to the 3-month (first follow-up) x-ray. The progression of the curve will be calculated according to the formula: (2-year Cobb angle - 3-month Cobb angle) / (2-year Cobb angle) × 100%.
Time frame
At 2-year follow-up for each subject assessed up to the 2-year follow-up of the last subject.4
Progression of secondary curve angles at 2-years standing x-ray
Progression of secondary curve angles at 2-years standing x-ray compared to the 3-month (first follow-up) x-ray. The progression of the curve will be calculated according to the formula: (2-year Cobb angle - 3-month Cobb angle) / (2-year Cobb angle) × 100%.
Time frame
During the 2-year follow-up for each subject up to the 2-year follow-up of the last subject.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala University
Lead sponsor
University of Oslo
Collaborator
Karolinska University Hopsital
Collaborator
University Hospital, Umeå
Collaborator
Örebro University, Sweden
Collaborator
Skane University Hospital
Collaborator
Sahlgrenska University Hospital
Collaborator
Uppsala University Hospital
Collaborator
Linkoeping University
Collaborator
Source ClinicalTrials.gov
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