The present study intends to: 1)establish a multi-center large-sample randomized controlled trial to explore the technical advantages and surgical indications of the novel surgical technique of CLIF correction for ASD compared with the conventional correction strategy; 2)analyze the postoperative clinical and imaging results, and to explore the related complications and preventive measures; 3) establish 2-year follow-up to further quantify the clinical and radiographical outcomes of CLIF correction.
Adult spinal deformity (ASD) is the most common spinal deformity in the elder, which often causes the low back pain and/or physical deformity. Severe cases need surgical treatment. Because the conventional posterior approach had the disadvantages of big trauma and slow recovery, and the elder were always complicated with complicated medical diseases, the perioperative risk was high. At present, the novel surgical technique of CLIF correction was a popular way for ASD treatment. Preliminary results showed that it had less trauma, shorter operation time, faster recovery, fewer complications and remarkable clinical and adiographical outcomes. Therefore, the present study intends to: 1) establish a multi-center large-sample randomized controlled trial to explore the technical advantages and surgical indications of the novel CLIF correction for ASD treatment compared with the conventional correction strategy; 2) establish 2-year follow-up to further quantify the clinical and radiographical outcomes, and to explore the related complications and preventive measures;. Therefore, the present project aims to explore the best surgical plan for treating ASD by studying the safety and effectiveness of the novel CLIF correction, and provide new surgical strategies for minimally invasive and Individualized treatment for ASD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach
conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach
Second Affiliated Hospital, School of Medicine, Zejiang University
Hangzhou, Zhejiang, China
ODI score
ODI score is Oswestry Disability Index(0-100), indicating the back pain; the higher score, the greater back pain
Time frame: 2 year after surgery
SF-36 score
SF-36 score is the MOS item short from health survey (0-100), indicating the life quality; the higher score, the better life quality
Time frame: 2 year after surgery
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