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NCT Number: NCT06093087

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

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

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Key information

Conditions

BKP Kummell's Disease Osteoporotic Vertebral Compression Fracture Stent-screw-assisted Internal Fixation

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

BKP

Procedure

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.

Primary outcomes

  1. ODI score

    Time frame: 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 outcomes

  1. CT imaging indicators related to vertebral body stability

    Time frame: 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)

  2. SF36 score

    Time frame: 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

  3. VAS score

    Time frame: 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

  4. EQ-5D score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wanli Li, MD

CONTACT

[email protected]

+86 13967116021

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Internal Fixation Reconstruction With Stent Screw VS Balloon Kyphoplasty in the Treatment of Kummell's Disease: a Double Blinded Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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