CLIF Correction VS. Conventional Correction Strategy for ASD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2028-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

with/without novel CLIF correction

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Novel CLIF correction

ASD patients with novel CLIF correction

Group Type EXPERIMENTAL

CLIF correction

Intervention Type PROCEDURE

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

conventional correction strategy

ASD patients with conventional correction strategy

Group Type ACTIVE_COMPARATOR

conventional correction strategy

Intervention Type PROCEDURE

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

Interventions

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CLIF correction

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

Intervention Type PROCEDURE

conventional correction strategy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No