Kummell DiseaseKD-CASSIFNCT07724236

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

An observational study of Kummell Disease, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Kummell Disease
Type of treatment: Injection or infusion
How many people: 60 participants
Where: 1 siteChina
Study dates: 30 Nov 2025to 30 Jun 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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;

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine
Guangzhou, Guangdong, 510405

Other trials in China

About this study

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

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07724236
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Vertebral Anterior Height Maintenance Rate
Measured: Baseline (within 7 days preoperatively) and at the 3-month postoperative follow-up visit
Postoperative Incidence of Complications Related to Internal Fixation
Measured: From surgery through the 3-month postoperative follow-up visit
Preoperative Anterior Height of Intervertebral Disc
Measured: Baseline (within 7 days preoperatively)
Postoperative Anterior Height of Intervertebral Disc
Measured: At discharge
Preoperative Anterior Height of Ajacent Healthy Intervertebral Discs
Measured: Baseline (within 7 days preoperatively)
Postoperative Anterior Height of Adjacent Healthy Intervertebral Discs
Measured: At discharge

Secondary outcomes (9)

Postoperative Lumbar Pain Visual Analogue Scale Score
Visual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.
Measured: At the 3-month postoperative follow-up visit
Preoperative Lumbar Pain Visual Analog Scale Score
Visual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.
Measured: Baseline (within 7 days preoperatively)
Postoperative Lower Extremity Pain Visual Analog Scale score
Visual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.
Measured: At the 3-month postoperative follow-up visit
Preoperative Lower Extremity Pain Visual Analog Scale Score
Visual Analogue Scale (VAS) for lumbar pain, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse outcome.
Measured: Baseline (within 7 days preoperatively)
Preoperative Oswestry Disability Index
Oswestry Disability Index (ODI), ranging from 0 (no disability) to 50 (maximum disability), with higher scores indicating worse outcome.
Measured: Baseline (within 7 days preoperatively)
Postoperative Oswestry Disability Index
Oswestry Disability Index (ODI), ranging from 0 (no disability) to 50 (maximum disability), with higher scores indicating worse outcome.
Measured: At the 3-month postoperative follow-up visit.
Preoperative Cobb's angle
Measured: Baseline (within 7 days preoperatively)
Postoperative Cobb's angle
Measured: At the 3-month postoperative follow-up visit
Reoperation rate
Measured: Up to 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202530 Jun 2026

First posted24 Jul 2026
Study start30 Nov 2025
Primary completion31 Jan 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Kummell DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07724236
Sponsor's protocol ID: DWang
Acronym: KD-CASSIF
Status last verified: Jul 2026
First submitted: 18 Jul 2026
Last updated: 24 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Study on the Treatment of Stage ll Kümmell's Disease With Cement-Augmented Short-Segment Internal Fixation
ClinicalTrials.gov ID: NCT07724236
Acronym / sponsor ID: KD-CASSIF / DWang
Conditions: Kummell Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
Study start: 30 Nov 2025 (actual)
Primary completion: 31 Jan 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 24 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)
Postoperative Anterior Height of Adjacent Healthy Intervertebral Discs
Time frame: At discharge

9 secondary outcomes

Postoperative Lumbar Pain Visual Analogue Scale Score
Time frame: At the 3-month postoperative follow-up visit
Preoperative Lumbar Pain Visual Analog Scale Score
Time frame: Baseline (within 7 days preoperatively)
Postoperative Lower Extremity Pain Visual Analog Scale score
Time frame: At the 3-month postoperative follow-up visit
Preoperative Lower Extremity Pain Visual Analog Scale Score
Time frame: Baseline (within 7 days preoperatively)
Preoperative Oswestry Disability Index
Time frame: Baseline (within 7 days preoperatively)
Postoperative Oswestry Disability Index
Time frame: At the 3-month postoperative follow-up visit.
Preoperative Cobb's angle
Time frame: Baseline (within 7 days preoperatively)
Postoperative Cobb's angle
Time frame: At the 3-month postoperative follow-up visit
Reoperation rate
Time frame: Up to 3 months after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Kummell Disease, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertebral Anterior Height Maintenance Rate (time frame: Baseline (within 7 days preoperatively) and at the 3-month postoperative follow-up visit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07724236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.