Status:
NOT_YET_RECRUITING
Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
BKP
Osteoporotic Vertebral Compression Fracture
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
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 stabilit...
Eligibility Criteria
Inclusion
- 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
- 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.
- Pregnancy during the study or planning to become pregnant.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06093087
Start Date
January 1 2024
End Date
September 1 2027
Last Update
October 23 2023
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