CLIF Correction VS. Conventional Correction Strategy for ASD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CLIF correction, conventional correction strategy.
- Who it may be relevant to
- Registry conditions: Spinal Deformity. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Procedure CLIF correction
CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach - Procedure conventional correction strategy
conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach
Primary outcome measures
- ODI score [Time frame: 2 year after surgery]
Secondary outcome measures (1)
- SF-36 score [Time frame: 2 year after surgery]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Affiliated Hospital, School of Medicine, Zejiang University — Hangzhou
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. PMID 16328223
- 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
- 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
- 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
Identifiers
NCT: NCT05982808 · CLIF correction for ASD