Clinical trial NCT05519332: Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
Official title: Percutaneous Vertebral-disc Plasty for Thoracolumbar Very Severe Osteoporotic Vertebral Compression Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporotic Fracture of Vertebra
Keywords: percutaneous vertebroplasty
percutaneous cement discoplasty
Lead sponsor: Affiliated 2 Hospital of Nantong University
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 58
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline visual analogue scale
timeFrame: One day before operation, one day after operation and 1year.
measure: Change from Baseline Oswestry Disability Index
timeFrame: One day before operation, one day after operation and 1year.
measure: Change from Baseline the local kyphotic angle
timeFrame: One day before operation, one day after operation and 1year.
Secondary outcomes:
measure: Change from Baseline the disc height anterior
timeFrame: One day before operation, one day after operation and 1year.
measure: Change from Baseline the disc height posterior
timeFrame: One day before operation, one day after operation and 1year.
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated 2 Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated 2 Hospital of Nantong University
name: Guanhua Xu, Dr
role: PRINCIPAL_INVESTIGATOR
References: