A Retrospective Study on the Treatment of Stage II Kümmell's Disease With Cement-Augmented Short-… (NCT07724236) | Clinical Trial Compass
CompletedNot Applicable
A Retrospective Study on the Treatment of Stage II Kümmell's Disease With Cement-Augmented Short-Segment Internal Fixation (KD-CASSIF)
China60 participantsStarted 2025-11-30
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vertebral Anterior Height Maintenance Rate
Timeframe: Baseline (within 7 days preoperatively) and at the 3-month postoperative follow-up visit
2
Postoperative Incidence of Complications Related to Internal Fixation
Timeframe: From surgery through the 3-month postoperative follow-up visit
3
Preoperative Anterior Height of Intervertebral Disc
Timeframe: Baseline (within 7 days preoperatively)
4
Postoperative Anterior Height of Intervertebral Disc
Timeframe: At discharge
5
Preoperative Anterior Height of Ajacent Healthy Intervertebral Discs
Timeframe: Baseline (within 7 days preoperatively)
6
Postoperative Anterior Height of Adjacent Healthy Intervertebral Discs
Timeframe: At discharge
Trial details
NCT IDNCT07724236
SponsorThe First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
. 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;