Randomized Controlled Trial of Internal Fixation Reconstr... | NCT06093087

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAIF	Experimental	patients will be treated with kyphoplasty surgery combined with pedicular screw-assisted internal fixation for vertebral augmentation	Procedure: SAIF
BKP	Active Comparator	patients will be treated with balloon kyphoplasty surgery for vertebral augmentation	Procedure: BKP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAIF	Procedure	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 The puncture needle core was withdrawn after puncturing, and a guide needle was inserted.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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ODI score	Each patients were asked to complete the Oswestry Disability Index questionnaire postoperatively during follow up	ODI score measured 1,3,6 months post surgery during follow up

Secondary Outcomes

Measure	Description	Time Frame
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)	all variables were measured 1,3,6 months post surgery during follow up

Eligibility Module

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.
Pregnancy during the study or planning to become pregnant.