Spinal Deformity
Conditions
Keywords
adult spinal deformity, CLIF, crenal lumbar interbody fusion, minimal invasive, correction, surgical strategy
Brief summary
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
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.
Interventions
PROCEDUREconventional correction strategy
conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach
PROCEDURECLIF correction
CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
with/without novel CLIF correction
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ODI score | 2 year after surgery | ODI score is Oswestry Disability Index（0-100）, indicating the back pain; the higher score, the greater back pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 score | 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 |
Countries
China
Contacts
Primary ContactZhi-wei WANG, Ph.D and MD.
Backup ContactFang-cai LI, Ph.D and MD.
Outcome results
None listed