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 range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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