Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis: Randomized Trial.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a randomized trial with 1:1 allocation. The aim of the study is to evaluate clinical and radiographic outcomes in patients with developmental age idiopathic scoliosis treated with mini invasive scoliosis surgery (MIS) technique versus posterior spinal fusion (PSF) technique through clinical and radiographic evaluations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 25
Healthy Volunteers: f
View:

• Patients with AIS

• Age between 12 and 25 years;

• Site of scoliotic curve: thoracic and/or lumbar;

• Preoperative radiographic range of the main scoliotic curve between 40° and 70° according to Cobb;

• Ability and consent of patients/parents to actively participate in the study and clinical follow-up.

Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Contact Information
Primary
Alessandro Gasbarrini, MD
alessandro.gasbarrini@ior.it
6366528
Backup
Bruna Maccaferri, MD
bruna.maccaferri@ior.it
6366567
Time Frame
Start Date: 2023-07-15
Estimated Completion Date: 2032-06
Participants
Target number of participants: 126
Treatments
Experimental: mini invasive scoliosis surgery (MIS)
This technique involves making small, noncontiguous, midline skin incisions at the levels to be instrumented, usually proximal and distal to the area of arthrodesis. A median fascial incision is then made to expose the vertebral segments on which to thread the screws while the bar is inserted submuscularly in a cranio-caudal direction, after appropriate maneuvers to correct the deformity.
Active_comparator: posterior spinal fusion technique (PSF)
This technique is the surgical gold standard. It consists of an instrumented arthrodesis with posterior access and requires a wide median incision with extensive muscle dissection.
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov