Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment… (NCT06093087) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease
70 participantsStarted 2024-01-01
Plain-language 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
Who can participate
Age range60 Years
SexALL
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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. VC…
What they're measuring
1
ODI score
Timeframe: ODI score measured 1,3,6 months post surgery during follow up
Trial details
NCT IDNCT06093087
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University