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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07724236
Acronym
KD-CASSIF
Enrollment
60
Registered
2026-07-24
Start date
2025-11-30
Completion date
2026-06-30
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kummell Disease

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.

Interventions

None listed

Sponsors

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients with imaging findings consistent with stage II KD and corresponding clinical symptoms and signs; 2. All cases involve single-level lesions; 3. Individuals who have shown no improvement or experienced symptom progression after more than 6weeks of conservative treatment; 4. Patients with complete clinical and imaging data before and after surgery; 5. Those who were followed up for at least 3 months postoperatively.

Exclusion criteria

1. Patients with multilevel lumbar spondylolisthesis; 2. Individuals with a history of previous lumbar spine surgery; 3. Patients with spinal infection; 4. Individuals with uncontrolled hypertension; 5. Patients with uncontrolled diabetes mellitus; 6. Those with severe impairment of cardiac, pulmonary, liver, or kidney function; 7. Patients with gonadal diseases, adrenal diseases, parathyroid diseases, thyroid diseases, and pituitary disorders; 8. 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; 9. Patients who have participated in any drug clinical trial within the last six months before screening; 10. Individuals with a clear history of mental illness or cognitive impairment who are unable to cooperate with follow-up and efficacy assessments; 11. Patients deemed unsuitable for participation in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
Vertebral Anterior Height Maintenance RateBaseline (within 7 days preoperatively) and at the 3-month postoperative follow-up visit
Postoperative Incidence of Complications Related to Internal FixationFrom surgery through the 3-month postoperative follow-up visit
Preoperative Anterior Height of Intervertebral DiscBaseline (within 7 days preoperatively)
Postoperative Anterior Height of Intervertebral DiscAt discharge
Preoperative Anterior Height of Ajacent Healthy Intervertebral DiscsBaseline (within 7 days preoperatively)
Postoperative Anterior Height of Adjacent Healthy Intervertebral DiscsAt discharge

Secondary

MeasureTime frameDescription
Postoperative Lumbar Pain Visual Analogue Scale ScoreAt the 3-month postoperative follow-up visitVisual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.
Preoperative Lumbar Pain Visual Analog Scale ScoreBaseline (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.
Postoperative Lower Extremity Pain Visual Analog Scale scoreAt the 3-month postoperative follow-up visitVisual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.
Preoperative Lower Extremity Pain Visual Analog Scale ScoreBaseline (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.
Preoperative Oswestry Disability IndexBaseline (within 7 days preoperatively)Oswestry Disability Index (ODI), ranging from 0 (no disability) to 50 (maximum disability), with higher scores indicating worse outcome.
Postoperative Oswestry Disability IndexAt 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.
Preoperative Cobb's angleBaseline (within 7 days preoperatively)
Postoperative Cobb's angleAt the 3-month postoperative follow-up visit
Reoperation rateUp to 3 months after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026