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CLIF Correction VS. Conventional Correction Strategy for ASD

Primary Purpose

Spinal Deformity

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CLIF correction
conventional correction strategy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Deformity focused on measuring adult spinal deformity, CLIF, crenal lumbar interbody fusion, minimal invasive, correction, surgical strategy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novel CLIF correction

conventional correction strategy

Arm Description

ASD patients with novel CLIF correction

ASD patients with conventional correction strategy

Outcomes

Primary Outcome Measures

ODI score
ODI score is Oswestry Disability Index(0-100), indicating the back pain; the higher score, the greater back pain

Secondary Outcome Measures

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

Full Information

First Posted
July 31, 2023
Last Updated
August 7, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05982808
Brief Title
CLIF Correction VS. Conventional Correction Strategy for ASD
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Deformity
Keywords
adult spinal deformity, CLIF, crenal lumbar interbody fusion, minimal invasive, correction, surgical strategy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
with/without novel CLIF correction
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novel CLIF correction
Arm Type
Experimental
Arm Description
ASD patients with novel CLIF correction
Arm Title
conventional correction strategy
Arm Type
Active Comparator
Arm Description
ASD patients with conventional correction strategy
Intervention Type
Procedure
Intervention Name(s)
CLIF correction
Intervention Description
CLIF correction was a novel surgical techqiue of correction of spinal deformtiy with minimal invasive approach
Intervention Type
Procedure
Intervention Name(s)
conventional correction strategy
Intervention Description
conventional correction was the classic surgical techqiue of correction of spinal deformtiy with open posterior approach
Primary Outcome Measure Information:
Title
ODI score
Description
ODI score is Oswestry Disability Index(0-100), indicating the back pain; the higher score, the greater back pain
Time Frame
2 year after surgery
Secondary Outcome Measure Information:
Title
SF-36 score
Description
SF-36 score is the MOS item short from health survey (0-100), indicating the life quality; the higher score, the better life quality
Time Frame
2 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-wei WANG, Ph.D and MD.
Phone
0571-88981080
Ext
86
Email
2316002@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-cai LI, Ph.D and MD.
Phone
0571-88981080
Email
2505004@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-wei WANG, Ph.D and MD.
Organizational Affiliation
2nd Hospital, Zhejiang University, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
When the first stage is done, the study plan would be open for others
Citations:
PubMed Identifier
16328223
Citation
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.
Results Reference
result
PubMed Identifier
26378361
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.
Results Reference
result
PubMed Identifier
15864163
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.cd.
Results Reference
result
PubMed Identifier
20683385
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). 2011 May 1;36(10):817-24. doi: 10.1097/BRS.0b013e3181e21783.
Results Reference
result

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CLIF Correction VS. Conventional Correction Strategy for ASD

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