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

NCT07724236 | Completed

• 1 other identifier: DWang
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Kummell Disease

Outcome Measures

Primary Outcomes (6)

• Vertebral Anterior Height Maintenance Rate

  Baseline (within 7 days preoperatively) and at the 3-month postoperative follow-up visit

• Postoperative Incidence of Complications Related to Internal Fixation

  From surgery through the 3-month postoperative follow-up visit

• Preoperative Anterior Height of Intervertebral Disc

  Baseline (within 7 days preoperatively)

• Postoperative Anterior Height of Intervertebral Disc

  At discharge

• Preoperative Anterior Height of Ajacent Healthy Intervertebral Discs

  Baseline (within 7 days preoperatively)

• Postoperative Anterior Height of Adjacent Healthy Intervertebral Discs

  At discharge

Secondary Outcomes (9)

• Postoperative Lumbar Pain Visual Analogue Scale Score

  At the 3-month postoperative follow-up visit

• Preoperative Lumbar Pain Visual Analog Scale Score

  Baseline (within 7 days preoperatively)

• Postoperative Lower Extremity Pain Visual Analog Scale score

  At the 3-month postoperative follow-up visit

• Preoperative Lower Extremity Pain Visual Analog Scale Score

  Baseline (within 7 days preoperatively)

• Preoperative Oswestry Disability Index

  Baseline (within 7 days preoperatively)

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study includes 60 patients diagnosed with stage II KD with single-level involvement, who failed conservative treatment for ≥6 weeks. All patients had complete preoperative and postoperative clinical/imaging data with at least 3 months of follow-up. Patients were divided into two groups: PVP alone (n=30) and combined procedure (vertebral augmentation with short-segment percutaneous cement-augmented pedicle screw fixation, n=30). Exclusion criteria: multilevel lesions, prior lumbar surgery, spinal infection, uncontrolled hypertension, diabetes, severe cardiopulmonary/hepatic/renal dysfunction, endocrine disorders, immunodeficiency/malignancy, psychiatric/cognitive impairment, or participation in drug trials within 6 months.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine

Guangzhou, Guangdong, 510405, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 24, 2026
• Study Start: November 30, 2025
• Primary Completion: January 31, 2026
• Study Completion: June 30, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

CN (1)