PKP Assisted With MR Technology in OVCF With IVC

Not Applicable

Completed

• Conditions: Orthopedic Disorder of Spine
• Interventions: Device: Mixed Reality technology

• Registration Number: NCT03959059
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-06-15
• Primary Completion: 2017-09-30
• Study Completion: 2018-03-20
• Status Verified: 2019-05
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-21
• Last Update Submitted: 2019-05-21
• Study First Posted: 2019-05-22
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PKP of traditional procedure	Mixed Reality technology	traditional method of PKP

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	1 year	Oswestry Disability Index is for movement function, Questionnaire examines perceived level of disability in everyday activities of daily living. The ODI score (index) is calculated as: For example: If all 10 sections are completed, the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32%; If one section is missed (or not applicable), the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5%.
visual analog scale	1 year	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Vertebral height	1 year	Vertebral height in X-ray is for recontruction of the vertebra.
Kyphotic angle	1 year	kyphotic angle in X-ray is also for recontruction of the vertebra.

Trial Locations

Locations (1)

Mixed Reality; 🇨🇳 Nanjing, Jiangsu, China