PKP Assisted With MR Technology in OVCF With IVC

Orthopedic Disorder of Spine Clinical Trial

Official title:

Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959059
• Other study ID #: KY20160122-47
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: May 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 20, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder of Spine
• Spinal Diseases

Intervention

Device:
• Mixed Reality technology
combine image with real body

Locations

Country	Name	City	State
China	Mixed Reality	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.	1 year
Primary	Oswestry Disability Index	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%.	1 year
Primary	Vertebral height	Vertebral height in X-ray is for recontruction of the vertebra.	1 year
Primary	Kyphotic angle	kyphotic angle in X-ray is also for recontruction of the vertebra.	1 year