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Effect of percutaneous vertebroplasty vs. kyphoplasty in treatment of Kümmell’s disease

Comparison of the clinical outcomes of percutaneous vertebroplasty vs. kyphoplasty for the treatment of osteoporotic Kümmell’s disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200325046855N1
Enrollment
60
Registered
2020-04-11
Start date
2637-02-20
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Kümmell’s disease is a special type of osteoporotic vertebral compression fracture (OVCF), which is relatively rare in clinical practice. Kümmell's disease is also known as nonunion after OVCF, delayed vertebral osteonecrosis after trauma, and delayed vertebral collapse. Imaging examination can discover the late-onset collapse of vertebrae and characteristic change of intravertebral vacuum cleft (IVC), which is considered one of important inducing factors for injured vertebral progress after the

Interventions

Intervention 1: Intervention group: PVP group of surgeries were performed by the same group of physicians, and the PVP procedures followed the same principle. The patients were placed in the prone pos

Sponsors

National Natural Science Foundation of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients suffered single-segment Kümmell's disease without new OVCF in the adjacent vertebrae; Computed tomography (CT) or magnetic resonance imaging (MRI) examination confirmed the existence of IVC. the IVC refers to a significant radiolucency (gas containing), which is located centrally or adjacent to the vertebral body endplates as seen on CT or plain radiographs. On MRI, it is usually shown as a low signal intensity on a T1-weighted image and as a high signal or a low signal on a T2-weighted image, depending on whether the fluid or gas fills the cleft; Dual energy X-ray measurement of bone mineral density (BMD) T value was less than -2.5; PVP or PKP was conducted with bilateral pedicle; Follow-up time was more than 2 years; Postoperative calcium supplementation and anti-osteoporotic drugs were applied; No fall or other trauma occurred.

Exclusion criteria

Exclusion criteria: Patients with severe cardiopulmonary dysfunction; Patients with coagulopathy; Patients with local or systemic infection; Patients with nerve root or spinal cord compression symptoms; Patients with pathological fractures other than osteoporosis.

Design outcomes

Primary

MeasureTime frame
The Oswestry disability index (ODI). Timepoint: before surgery, at 1 days, 1 year and 2 years after surgery. Method of measurement: The ODI scale was used to evaluate the severity of the dysfunction [9].;Visual analogue scale (VAS). Timepoint: before surgery, at 1 days, 1 year and 2 years after surgery. Method of measurement: VAS is measured according to visual analogue scale.;Bone cement leakage rate. Timepoint: After surgery. Method of measurement: X-ray film is used to observe whether there is leakage of bone cement.;The incidence of new adjacent vertebral fracture. Timepoint: at 1 days, 1 year and 2 years after surgery. Method of measurement: X-ray film is used to observe whether there is a new adjacent vertebral fracture.;Rate of vertebral compression. Timepoint: before surgery, at 1 days, 1 year and 2 years after surgery. Method of measurement: Imaging measurement indexes: the height of the injured vertebral body and the kyphosis angle were measured before and after the operation by the anteroposterior and lateral X-ray images[10]. And the following indexes were calculated. 1) Rate of vertebral compression = the height of the injured vertebral body / the average height of adjacent upper and lower vertebral body heights [10];.;Correction degree of kyphosis. Timepoint: before surgery, at 1 days, 1 year and 2 years after surgery. Method of measurement: Imaging measurement indexes: the height of the injured vertebral body and the kyphosis angle were measured before and after the operation by the anteroposterior and lateral X-ray images[10]. And the following indexes were calculated. Correction degree of kyphosis = (preoperative kyphosis angle - postoperative kyphosis angle) / preoperative kyphosis angle × % [11].

Secondary

MeasureTime frame
Complications of bone cement. Timepoint: intraoperation and postoperation. Method of measurement: Closely observe the patient's symptoms and consult chief complaint and conduct related clinical examination?.

Countries

China

Contacts

Public ContactCheng-Liang Wang

CR & WISCO General Hospital

13476174874@139.com+86 27 8648 7273

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026