A Phase 1/2 interventional study of SAIF and BKP in BKP, Osteoporotic Vertebral Compression Fracture and Kummell's Disease, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 1/2, Interventional, and Treatment
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
50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.
This study's planned enrollment of 70 is close to the median of 73 across 32 interventional studies indexed under Fractures, Compression.
Browse Fractures, Compression studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients will be treated with kyphoplasty surgery combined with pedicular screw-assisted internal fixation for vertebral augmentation
Procedure: SAIF
patients will be treated with balloon kyphoplasty surgery for vertebral augmentation
Procedure: BKP
The patient was placed in a prone position under general anesthesia. Using a C-arm X-ray machine and a positioning plate for navigation, the target position on the vertebral body was located one the surface of the body. The puncture needle core was withdrawn after puncturing, and a guide needle was inserted. After removing the puncture needle sleeve, a hollow bone cement screw was screwed into the anterior column of the vertebral body through the guide needle. Subsequently, bone cement was injected into the appropriate position through the bone cement screw to restore the vertebral height
The patient was placed in a prone position after general anesthesia. Using a C-arm X-ray machine and a positioning plate for guidance, the target position on the vertebral body was located from the surface of the body. A puncture needle sleeve was inserted into the vertebral body. A PKP balloon was then inserted to perform vertebral restoration. After removing the balloon, an appropriate amount of bone cement was injected to ensure even distribution within the vertebral body. Vertebral height augmentation and restoration will then be achieved.
ODI score
Each patients were asked to complete the Oswestry Disability Index questionnaire postoperatively during follow up
Time frame: ODI score measured 1,3,6 months post surgery during follow up
CT imaging indicators related to vertebral body stability
There are total 5 indicators measured based on CT images: Anterior vertebral height (ant VBH), middle vertebral height (mid VBH), posterior vertebral height (post VBH), vertebral kyphosis angle (VKA), local kyphosis angle (LKA)
Time frame: all variables were measured 1,3,6 months post surgery during follow up
SF36 score
SF-36 questionnaire aimed at two different constructs to measure health-related quality of life: the Physical Component and the Mental Component
Time frame: measured 1,3,6 months post surgery during follow up
VAS score
The Visual Analogue Scale (VAS) measures pain intensity. 0 indicates no pain and 10 indicates pain as bad as it could possibly be
Time frame: measured 1,3,6 months post surgery during follow up
EQ-5D score
The EQ-5D descriptive system measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: measured 1,3,6 months post surgery during follow up
No study locations are listed for this record.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →