PKP Assisted With MR Technology in OVCF With IVC

Nanjing Medical University

Status

Completed

Conditions

Orthopedic Disorder of Spine

Treatments

Device: Mixed Reality technology

Study type

Interventional

Funder types

Other

Identifiers

NCT03959059

KY20160122-47

Details and patient eligibility

About

To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.

Full description

The study is to prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC. Forty cases of OVCF with IVC undergoing PKP were randomized into a MR technology assisted group (group A) and a traditional C-arm fluoroscopy group (group B). Both groups were performed PKP and evaluated by VAS scores, ODI scores, radiological evidence of vertebral body height and kyphotic angle(KA) at pre-operation and post-operation. The volume of injected cement and Operation time was recorded. And whether cement touching both endplates or not(non-PMMA-endplates-contact, NPEC) in radiological evidence were also recorded postoperatively. The clinical outcomes and complications were evaluated afterwards. All patients received 10 to 14 months' follow-up, with an average of 12 months.

Enrollment

40 patients

Sex

All

Ages

50 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Single level OVCF in the thoracic and lumbar levels (T10-L4), suffering with severe back pain.;
OVCF without damaged vertebral posterior wall and nerve lesion;
The patient was over 50 years old and , the diagnosis of osteopenia or osteoporosis was confirmed by bone densitometry ;
All patients underwent（received） plain radiography, computed tomography (CT) and MRI before surgery, and with IVC presented in MRI.

Exclusion criteria