CLIF Correction VS. Conventional Correction Strategy for ASD

Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05982808
• Other study ID #: CLIF correction for ASD
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 1, 2028

Study information

• Verified date: August 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zhi-wei WANG, Ph.D and MD.
• Phone: 0571-88981080
• Email: 2316002[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

Intervention

Procedure:
• CLIF correction
CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach
• conventional correction strategy
conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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