Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease

Phase 1

Not yet recruiting

• Conditions: Stent-screw-assisted Internal Fixation; Kummell's Disease; BKP; Osteoporotic Vertebral Compression Fracture
• Interventions: Procedure: SAIF; Procedure: BKP

• Registration Number: NCT06093087
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23
• Study Start: 2024-01-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAIF	SAIF	patients will be treated with kyphoplasty surgery combined with pedicular screw-assisted internal fixation for vertebral augmentation
BKP	BKP	patients will be treated with balloon kyphoplasty surgery for vertebral augmentation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SF36 score	measured 1,3,6 months post surgery during follow up	SF-36 questionnaire aimed at two different constructs to measure health-related quality of life: the Physical Component and the Mental Component
EQ-5D score	measured 1,3,6 months post surgery during follow up	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.
CT imaging indicators related to vertebral body stability	all variables were measured 1,3,6 months post surgery during follow up	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)
VAS score	measured 1,3,6 months post surgery during follow up	The Visual Analogue Scale (VAS) measures pain intensity. 0 indicates no pain and 10 indicates pain as bad as it could possibly be