CLIF Correction VS. Conventional Correction Strategy for ASD

NCT05982808 | Not Yet Recruiting DMC

• 1 other identifier: CLIF correction for ASD
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Deformity

Keywords

adult spinal deformity; CLIF; crenal lumbar interbody fusion; minimal invasive; correction; surgical strategy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• SF-36 score

  2 year after surgery

Study Arms (2)

Novel CLIF correction

EXPERIMENTAL

ASD patients with novel CLIF correction

Procedure: CLIF correction

conventional correction strategy

ACTIVE COMPARATOR

ASD patients with conventional correction strategy

Procedure: conventional correction strategy

Interventions

CLIF correction PROCEDURE

CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach

Novel CLIF correction

conventional correction strategy PROCEDURE

conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach

conventional correction strategy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult spinal deformtiy;
• yrs≤age≤80yrs;
• Lenke-Silva classification II-V grade;
• ineffective with conservative treatment;

You may not qualify if:

• severe osteoprosis with T value \<-2.5;
• with preliminary spinal surgery;
• ASA score≥III grade;
• more than II degree spondylisthesis;
• with mental disease;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related 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.

  PMID: 16328223 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.

  PMID: 26378361 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.

  PMID: 15864163 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.

  PMID: 20683385 RESULT

Study Officials

• Zhi-wei WANG, Ph.D and MD.

  2nd Hospital, Zhejiang University, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-wei WANG, Ph.D and MD.

CONTACT

0571-88981080; 2316002@zju.edu.cn

Fang-cai LI, Ph.D and MD.

CONTACT

0571-88981080; 2505004@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: with/without novel CLIF correction

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 9, 2023
• Study Start: July 1, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)