Minimal Invasive Scoliosis or Open Surgery

NCT07203586 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-10-02

No results posted yet for this study

Summary

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.

Conditions

  • Idiopathic Adolescent Scoliosis
  • Idiopathic Juvenile Scoliosis

Interventions

PROCEDURE

Minimally invasive scoliosis surgery

Patients 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.

PROCEDURE

Traditional open scoliosis surgery group

In 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.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER
  • Karolinska University Hopsital

    collaborator UNKNOWN
  • University Hospital, Umeå

    collaborator OTHER
  • Örebro University, Sweden

    collaborator OTHER
  • Skane University Hospital

    collaborator OTHER
  • Sahlgrenska University Hospital

    collaborator OTHER
  • Department of Orthopedics, Uppsala University Hospital

    collaborator UNKNOWN
  • Linkoeping University

    collaborator OTHER_GOV
  • Uppsala University

    lead OTHER

Principal Investigators

  • Nikos Schizas, MD, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07203586 on ClinicalTrials.gov