Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures

NCT ID: NCT05519332

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2025-12-31

Brief Summary

Purpose: To compare the clinical outcomes and radiological parameters of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing percutaneous vertebral-disc plasty (PVDP) for back pain, segmental instability, and kyphosis due to thoracolumbar very severe osteoporotic vertebral compression fractures (vsOVCFs).

This prospective study included elderly patients with thoracolumbar vsOVCFs. All the patients were randomly allocated into the PVP group (who underwent conventional PVP) and the PVDP group (who underwent PVP combined percutaneous cement discoplasty). The visual analogue scale (VAS), Oswestry Disability Index (ODI), local kyphosis angle, and disc height were recorded preoperatively and postoperatively.

Detailed Description

Patients diagnosed with thoracolumbar vsOVCFs in hospital and undergoing minimally invasive treatment from November 2019 to March 2021 were enrolled for the study. They were randomly allocated into two groups (based on random numbers generated by www. randomizer.org), namely PVP group and PVDP group.

Operative technique：In PVDP group, PVP and PCD both used a unilateral transpedicular approach into the vertebrae and disc. . Under general anesthesia, the patient was turned over to a prone position, and the deformity is reduced with a slight closed manipulative. Firstly, under fluoroscopic O-arm guidance, the puncture site was localized into the junction made by the transverse process and the superior articular process and entered the target area according to the puncture angle and depth measured before the operation. Secondly, the other puncture cannula was inserted into the intervertebral disc space adjacent to the ruptured endplate through the transpedicular access, and the target area was the middle of the intervertebral space. Thin-cut CT images were obtained intraoperatively by the O-arm fluoroscopy to confirm puncture needle placement location. Third, the bone cement was injected into the vertebrae and the intervertebral disc space, meanwhile, the cannula was also needed to move back to the vertebrae, and the bone cement in the vertebrae could connect the intervertebral disc space and the vertebrae to form a whole. Finally, the PVP group and the adjacent vertebrae performed by prophylactic vertebroplasty used bilateral pedicle puncture, under the guidance of the O-arm, two puncture needles were percutaneously inserted into the vertebrae, reaching about the middle of the vertebrae. Then, cement was slowly injected into the vertebral body, once cement leakage into the spinal canal or veins was detected, the injection was stopped.

The investigators measured radiological parameters including the local kyphotic angle (LKA), disc height anterior (DHA), and disc height posterior (DHP) from lateral plain radiographs preoperatively and at 1 day and final follow-up after surgery. The visual analog score (VAS) was used to assess the preoperative and postoperative back pain relief. The Oswestry Disability Index (ODI) was used to assess the quality of life and was recorded preoperatively, postoperatively, and final follow-up.

Conditions

Osteoporotic Fracture of Vertebra

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PVDP group

Patients underwent percutaneous vertebral-disc plasty

Group Type: EXPERIMENTAL

percutaneous vertebral-disc plasty

Intervention Type: PROCEDURE

percutaneous vertebroplasty combined percutaneous cement discoplasty

PVP group

Patients underwent conventional percutaneous vertebroplasty

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

percutaneous vertebral-disc plasty

percutaneous vertebroplasty combined percutaneous cement discoplasty

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• bone mineral density T scores <-2.5;
• compression of the vertebral anterior column greater than two-thirds of their original height;
• Kyphosis with LKA greater than 20°;
• the accordion phenomenon: the different angles of a supine CT scan and a lateral standing X-ray measurement;
• upper or lower vertebral endplate fracture;
• the involved vertebral body was intact;
• Elderly patients with a history of major illness (such as cardiovascular disease, cancer or active malignancy) and were intolerant of the traditional open surgery.

Exclusion Criteria

• Pathological vertebral fractures caused by spinal tumors, spinal tuberculosis, and spinal infection and so on;
• Patients with symptoms of nerve roots or spinal cord compression;
• Patients with a previous history of spinal fusion;
• A history of abnormal bleeding or coagulation disorder dysfunction.

• Minimum Eligible Age: 58 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiawei Jiang

OTHER

Sponsor Role: lead

Responsible Party

Jiawei Jiang

resident physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Guanhua Xu, Dr

Role: PRINCIPAL_INVESTIGATOR

Affiliated 2 Hospital of Nantong University

Locations

Affiliated 2 Hospital of Nantong University

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiawei Jiang, Dr

Role: CONTACT

18862802782@163.com

18862802782

Facility Contacts

Jiawei Jiang, Dr

Role: primary

18862802782@163.com

18862802782

Other Identifiers

JJiang

Identifier Type: -

Identifier Source: org_study_id