CLIF Correction VS. Conventional Correction Strategy for ASD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Spinal Deformity

Intervention / Treatment
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* Procedure: CLIF correction
* Procedure: conventional correction strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult spinal deformtiy; 40yrs≤age≤80yrs; Lenke-Silva classification II-V grade; ineffective with conservative treatment; Exclusion Criteria: severe osteoprosis with T value <-2.5; with preliminary spinal surgery; ASA score≥III grade; more than II degree spondylisthesis; with mental disease;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: with/without novel CLIF correction
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel CLIF correction<br>ASD patients with novel CLIF correction | Procedure: CLIF correction<br>* CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach<br>|
| Active Comparator: conventional correction strategy<br>ASD patients with conventional correction strategy | Procedure: conventional correction strategy<br>* conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODI score | ODI score is Oswestry Disability Index（0-100）, indicating the back pain; the higher score, the greater back pain | 2 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult spinal deformity, CLIF, crenal lumbar interbody fusion, minimal invasive, correction, surgical strategy