Internal Fixation Reconstruction With Stent Screw VS Balloon Kyphoplasty in the Treatment of Kummell's Disease: a Double Blinded Randomized Controlled Trial

Second Affiliated Hospital, School of Medicine, Zhejiang University0 sites70 target enrollmentJanuary 1, 2024

ConditionsBKP Osteoporotic Vertebral Compression Fracture Kummell's Disease Stent-screw-assisted Internal Fixation

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: BKP
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 70
Primary Endpoint: ODI score
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (Kummell's disease) are better with the use of stent screw internal fixation and percutaneous bone cement reconstruction technique compared to patients undergoing traditional percutaneous balloon kyphoplasty (BKP) for vertebral augmentation

Registry

clinicaltrials.gov

Start Date

January 1, 2024

End Date

September 1, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 60 or above, gender not specified.
•Must have one to three vertebral segments with vertebral compression fracture (VCF) located between T5 and L5, attributed to underlying primary or secondary osteoporosis rather than cancer.
•All VCFs must exhibit the following radiographic changes: according to Genant's criteria, acute (≤4 months) decrease in anterior, middle, or posterior vertebral height by at least one grade (20-25% reduction in vertebral height, 10-20% reduction in vertebral area) compared to previous X-ray, CT, or MRI results.
•All VCFs for treatment must occur within four months or less.
•All VCFs for treatment must be technically feasible and clinically suitable for BKP or SAIF surgery.
•Pre-treatment back pain NRS score must be ≥ 7 and ineffective with conservative (non-surgical) treatment.
•Pre-treatment Oswestry Disability Index must be ≥ 30 (on a scale of 0-100).
•Patient's life expectancy must be ≥ 12 months.
•Must declare willingness to participate in all post-operative follow-ups.
•Must be capable of understanding the risks and benefits of the study and willing to provide written informed consent.

Exclusion Criteria

•Vertebral morphology or fracture morphology unsuitable for balloon kyphoplasty. VCF caused by high-energy trauma.
•Asymptomatic VCF or vertebral bodies amenable to prophylactic treatment.
•VCF at the same site associated with primary bone tumors.
•Back pain caused by reasons other than acute fractures. VCF with an estimated fracture time of more than 4 months, based on clinical assessment (radiological evidence and patient history).
•VCF associated with secondary radiculopathy or neurological compromise.
•VCF requiring spinal surgery other than BKP or SAIF.
•Spinal cord compression or vertebral canal injury requiring decompression surgery.
•Combined clinical conditions unsuitable for surgery or affecting subsequent long-term data collection or follow-up.
•Allergy to any component during the surgical procedure (e.g., bone cement, contrast agents).
•Concurrent participation in another clinical study.

Outcomes

Primary Outcomes

ODI score

Time Frame: ODI score measured 1,3,6 months post surgery during follow up

Each patients were asked to complete the Oswestry Disability Index questionnaire postoperatively during follow up

Secondary Outcomes

SF36 score(measured 1,3,6 months post surgery during follow up)
EQ-5D score(measured 1,3,6 months post surgery during follow up)
CT imaging indicators related to vertebral body stability(all variables were measured 1,3,6 months post surgery during follow up)
VAS score(measured 1,3,6 months post surgery during follow up)