A Retrospective Study on the Treatment of Stage II Kümmell's Disease With Cement-Augmented Short-Segment Internal Fixation (KD-CASSIF) | NCT07724236

NCT07724236

Overview

NCT ID: NCT07724236
Lead Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineOTHER
Official Title: A Retrospective Study on the Treatment of Stage ll Kümmell's Disease With Cement-Augmented Short-Segment Internal Fixation
Brief Summary: This retrospective study compares the clinical and radiographic outcomes of percutaneous vertebroplasty (PVP) versus cement-augmented short-segment percutaneous pedicle screw fixation for the treatment of single-level stage II Kümmell's Disease (KD). A total of 60 patients who failed conservative treatment for at least 6 weeks and completed a minimum of 3 months of follow-up were included. The primary outcomes are Visual Analogue Scale (VAS) for low back and lower limb pain, and Cobb's angle correction and maintenance rates. Secondary outcomes include Oswestry Disability Index (ODI), vertebral anterior height maintenance rate, implant-related complications, and reoperation rate. This study aims to provide evidence for optimizing treatment strategies in stage II KD.
Conditions

Status and Timeline

Status: Completed
Last Update Posted: Jul 24, 2026Actual
Start Date: Nov 30, 2025Actual
Primary Completion Date: Jan 31, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patients with imaging findings consistent with stage II KD and corresponding clinical symptoms and signs;

All cases involve single-level lesions;

Individuals who have shown no improvement or experienced symptom progression after more than 6weeks of conservative treatment;

Patients with complete clinical and imaging data before and after surgery;

Those who were followed up for at least 3 months postoperatively.

Exclusion Criteria:

Patients with multilevel lumbar spondylolisthesis;

Individuals with a history of previous lumbar spine surgery;

Patients with spinal infection;

Individuals with uncontrolled hypertension;

Patients with uncontrolled diabetes mellitus;

Those with severe impairment of cardiac, pulmonary, liver, or kidney function;

Patients with gonadal diseases, adrenal diseases, parathyroid diseases, thyroid diseases, and pituitary disorders;

Individuals with a history of immunodeficiency diseases (such as HIV), cancer or malignant tumors, autoimmune diseases, severe cardiovascular or cerebrovascular diseases, or other conditions that may significantly reduce life expectancy;

Patients who have participated in any drug clinical trial within the last six months before screening;

Individuals with a clear history of mental illness or cognitive impairment who are unable to cooperate with follow-up and efficacy assessments;

Patients deemed unsuitable for participation in this study by the researchers.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 60Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine

Similar Studies

Participant Group/Arms

Percutaneous vertebroplasty Group

Percutaneous vertebroplasty (PVP): Under general anesthesia (GA), patient prone. Target vertebra and pedicles localized under C-arm fluoroscopy. Skin incisions \~0.3-0.5 cm. Puncture needles inserted via pedicular trajectory under lateral fluoroscopy to posterior cortex, then tapped into anterior-middle third of vertebral body. Stylets removed; cement cannulas inserted. High-viscosity cement prepared under vacuum to late stringy phase, loaded into syringes, and slowly injected at low pressure under continuous fluoroscopy. Cement dispersion monitored to prevent leakage into spinal canal, discs, or veins. Injection stopped when 50%-70% filling achieved or extravasation detected. After cement hardening, cannulas and sheaths withdrawn. Incisions irrigated, drains placed, wounds closed in layers.

Combined Surgical Group

Vertebral augmentation with short-segment cement-augmented pedicle screw fixation: Under GA, patient prone with chest/abdomen padded. Target vertebra and adjacent pedicles (one level above/below) localized under C-arm; skin marked. Four 1.5-cm incisions. Guidewires inserted under biplanar fluoroscopy; tissues dilated; cannulas and screws placed, with temporary rod on one side. At target level, guidewire removed; drill advanced to anterior-middle third for cement channel. Balloon inserted, inflated to elevate endplates, correct kyphosis, create cavity, then removed. High-viscosity cement (late stringy) injected under fluoroscopy until satisfactory fill without leakage. After hardening, permanent rods placed bilaterally and locked. Wounds irrigated, drain placed, fascia/subcutaneous/skin closed, sterile dressings applied.