NCT03959059

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthopedic Disorder of Spine

Interventions

Type	Name	Description
DEVICE	Mixed Reality technology	combine image with real body

Timeline

• Start date: 2017-06-15
• Primary completion: 2017-09-30
• Completion: 2018-03-20
• First posted: 2019-05-22
• Last updated: 2019-05-22

Locations

1 site across 1 country: China