CLIF Correction VS. Conventional Correction Strategy for ASD

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Deformity
• Intervention / Treatment: Procedure: CLIF correction; Procedure: conventional correction strategy

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.

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhi-wei WANG, Ph.D and MD.; Phone Number: 86 0571-88981080; Email: 2316002@zju.edu.cn
• Study Contact Backup: Name: Fang-cai LI, Ph.D and MD.; Phone Number: 0571-88981080; Email: 2505004@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Second Affiliated Hospital, School of Medicine, Zejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Zhi-wei WANG, Ph.D and MD., 2nd Hospital, Zhejiang University, School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: minimal invasive; correction; adult spinal deformity; CLIF; crenal lumbar interbody fusion; surgical strategy
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CLIF correction for ASD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: When the first stage is done, the study plan would be open for others

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No