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NCT Number: NCT05982808

CLIF Correction VS. Conventional Correction Strategy for ASD

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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Key information

Conditions

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, School of Medicine, Zejiang University

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

CLIF correction

Procedure

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

conventional correction strategy

Procedure

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

Primary outcomes

  1. ODI score

    Time frame: 2 year after surgery

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

Secondary outcomes

  1. SF-36 score

    Time frame: 2 year after surgery

    SF-36 score is the MOS item short from health survey (0-100), indicating the life quality; the higher score, the better life quality

Study contacts

Contact information is provided by the study sponsor or research team.

Fang-cai LI, Ph.D and MD.

CONTACT

[email protected]

0571-88981080

Zhi-wei WANG, Ph.D and MD.

CONTACT

[email protected]

0571-88981080 ext. 86

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Aug 9, 2023
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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