PKP Assisted With MR Technology in OVCF With IVC

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

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

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder of Spine
• Intervention / Treatment: Device: Mixed Reality technology

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Mixed Reality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PKP of traditional procedure; traditional method of PKP	Device: Mixed Reality technology; combine image with real body

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.	1 year
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
Vertebral height	Vertebral height in X-ray is for recontruction of the vertebra.	1 year
Kyphotic angle	kyphotic angle in X-ray is also for recontruction of the vertebra.	1 year

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

General Publications

• Wei P, Yao Q, Xu Y, Zhang H, Gu Y, Wang L. Percutaneous kyphoplasty assisted with/without mixed reality technology in treatment of OVCF with IVC: a prospective study. J Orthop Surg Res. 2019 Aug 8;14(1):255. doi: 10.1186/s13018-019-1303-x.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases
• Other Study ID Numbers: KY20160122-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No