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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel CLIF correction | Experimental | ASD patients with novel CLIF correction |
|
| conventional correction strategy | Active Comparator | ASD patients with conventional correction strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLIF correction | Procedure | CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi-wei WANG, Ph.D and MD. | Contact | 0571-88981080 | 86 | 2316002@zju.edu.cn |
| Fang-cai LI, Ph.D and MD. | Contact | 0571-88981080 | 2505004@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-wei WANG, Ph.D and MD. | 2nd Hospital, Zhejiang University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zejiang University | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16328223 | Result | Aebi M. The adult scoliosis. Eur Spine J. 2005 Dec;14(10):925-48. doi: 10.1007/s00586-005-1053-9. Epub 2005 Nov 18. | |
| 26378361 | Result | Ailon T, Smith JS, Shaffrey CI, Lenke LG, Brodke D, Harrop JS, Fehlings M, Ames CP. Degenerative Spinal Deformity. Neurosurgery. 2015 Oct;77 Suppl 4:S75-91. doi: 10.1227/NEU.0000000000000938. |
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When the first stage is done, the study plan would be open for others
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with/without novel CLIF correction
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| conventional correction strategy | Procedure | conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach |
|
| 15864163 | Result | Schwab F, Dubey A, Gamez L, El Fegoun AB, Hwang K, Pagala M, Farcy JP. Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976). 2005 May 1;30(9):1082-5. doi: 10.1097/01.brs.0000160842.43482.cd. |
| 20683385 | Result | Smith JS, Shaffrey CI, Glassman SD, Berven SH, Schwab FJ, Hamill CL, Horton WC, Ondra SL, Sansur CA, Bridwell KH; Spinal Deformity Study Group. Risk-benefit assessment of surgery for adult scoliosis: an analysis based on patient age. Spine (Phila Pa 1976). 2011 May 1;36(10):817-24. doi: 10.1097/BRS.0b013e3181e21783. |