Clinical trial NCT06093087: Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease
Official title: Internal Fixation Reconstruction With Stent Screw VS Balloon Kyphoplasty in the Treatment of Kummell's Disease: a Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: BKP
Osteoporotic Vertebral Compression Fracture
Kummell's Disease
Stent-screw-assisted Internal Fixation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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


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.

Primary outcomes:
measure: ODI score
timeFrame: ODI score measured 1,3,6 months post surgery during follow up
Secondary outcomes:
measure: CT imaging indicators related to vertebral body stability
timeFrame: all variables were measured 1,3,6 months post surgery during follow up
measure: SF36 score
timeFrame: measured 1,3,6 months post surgery during follow up
measure: VAS score
timeFrame: measured 1,3,6 months post surgery during follow up
measure: EQ-5D score
timeFrame: measured 1,3,6 months post surgery during follow up
Other outcomes:
Locations:
Study officials:
References: