CLIF Correction VS. Conventional Correction Strategy for ASD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult spinal deformtiy;

40yrs≤age≤80yrs;

Lenke-Silva classification II-V grade;

ineffective with conservative treatment;

Disqualifiers

severe osteoprosis with T value <-2.5;

with preliminary spinal surgery;

ASA score≥III grade;

more than II degree spondylisthesis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • CLIF correction

    Procedure/Surgery

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

  • conventional correction strategy

    Procedure/Surgery

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

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Novel CLIF correctionExperimental treatment 1 intervention
Group B: conventional correction strategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ODI score

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 outcomes

1

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

Time frame
2 year after surgery

Other outcomes

Sponsors and contacts

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