A Retrospective Study on the Treatment of Stage ll Kümmell's Disease With Cement-Augmented Short-Segment Internal Fixation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative Anterior Height of Adjacent Healthy Intervertebral Discs
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Postoperative Anterior Height of Adjacent Healthy Intervertebral Discs
Time Frame: At discharge
Vertebral Anterior Height Maintenance Rate
Time Frame: Baseline (within 7 days preoperatively) and at the 3-month postoperative follow-up visit
Postoperative Incidence of Complications Related to Internal Fixation
Time Frame: From surgery through the 3-month postoperative follow-up visit
Preoperative Anterior Height of Intervertebral Disc
Time Frame: Baseline (within 7 days preoperatively)
Postoperative Anterior Height of Intervertebral Disc
Time Frame: At discharge
Preoperative Anterior Height of Ajacent Healthy Intervertebral Discs
Time Frame: Baseline (within 7 days preoperatively)
Secondary Outcomes
- 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))
- Postoperative Oswestry Disability Index(At the 3-month postoperative follow-up visit.)
- Preoperative Cobb's angle(Baseline (within 7 days preoperatively))
- Postoperative Cobb's angle(At the 3-month postoperative follow-up visit)
- Reoperation rate(Up to 3 months after surgery)
Investigators
Dongping Wang
Resident Physician
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine