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Completed

NCT Number: NCT07724236

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

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.

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Key information

Conditions

Kummell Disease

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine

Guangzhou, Guangdong, 510405, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Vertebral Anterior Height Maintenance Rate

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

  2. Postoperative Incidence of Complications Related to Internal Fixation

    Time frame: From surgery through the 3-month postoperative follow-up visit

  3. Preoperative Anterior Height of Intervertebral Disc

    Time frame: Baseline (within 7 days preoperatively)

  4. Postoperative Anterior Height of Intervertebral Disc

    Time frame: At discharge

  5. Preoperative Anterior Height of Ajacent Healthy Intervertebral Discs

    Time frame: Baseline (within 7 days preoperatively)

  6. Postoperative Anterior Height of Adjacent Healthy Intervertebral Discs

    Time frame: At discharge

Secondary outcomes

  1. Postoperative Lumbar Pain Visual Analogue Scale Score

    Time frame: At the 3-month postoperative follow-up visit

    Visual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.

  2. Preoperative Lumbar Pain Visual Analog Scale Score

    Time frame: Baseline (within 7 days preoperatively)

    Visual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.

  3. Postoperative Lower Extremity Pain Visual Analog Scale score

    Time frame: At the 3-month postoperative follow-up visit

    Visual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.

  4. Preoperative Lower Extremity Pain Visual Analog Scale Score

    Time frame: Baseline (within 7 days preoperatively)

    Visual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.

  5. Preoperative Oswestry Disability Index

    Time frame: Baseline (within 7 days preoperatively)

    Oswestry Disability Index (ODI), ranging from 0 (no disability) to 50 (maximum disability), with higher scores indicating worse outcome.

  6. Postoperative Oswestry Disability Index

    Time frame: At the 3-month postoperative follow-up visit.

    Oswestry Disability Index (ODI), ranging from 0 (no disability) to 50 (maximum disability), with higher scores indicating worse outcome.

  7. Preoperative Cobb's angle

    Time frame: Baseline (within 7 days preoperatively)

  8. Postoperative Cobb's angle

    Time frame: At the 3-month postoperative follow-up visit

  9. Reoperation rate

    Time frame: Up to 3 months after surgery

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Other

Registry information

Official study title

A Retrospective Study on the Treatment of Stage ll Kümmell's Disease With Cement-Augmented Short-Segment Internal Fixation

Acronym: KD-CASSIF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

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.