Second Affiliated Hospital, School of Medicine, Zejiang University
Hangzhou, Zhejiang, 310000, China
NCT Number: NCT05982808
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.
Trial opening soon.
Get Notified40 year–80 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 2 year after surgery
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 is the MOS item short from health survey (0-100), indicating the life quality; the higher score, the better life quality
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
A Novel Surgical Technique of CLIF Correction VS. Conventional Corrective Strategy on the Treatment of Adult Complex Spinal Deformity With a Multicenter Randomized Controlled Trial
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