CLIF Correction VS. Conventional Correction Strategy for ASD

Zhejiang University

Status: Not yet enrolling

Conditions: Spinal Deformity

Treatments: Procedure: conventional correction strategy; Procedure: CLIF correction

Study type: Interventional

Funder types: Other

Identifiers

NCT05982808

CLIF correction for ASD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

420 participants in 2 patient groups

Novel CLIF correction

Experimental group

Description:

ASD patients with novel CLIF correction

Treatment:

Procedure: CLIF correction

conventional correction strategy

Active Comparator group

Description:

ASD patients with conventional correction strategy

Treatment:

Procedure: conventional correction strategy