Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation

NCT ID: NCT02557113

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

Brief Summary

Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.

Conditions

Vertebral Body Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vertebroplasty

This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)

Group Type: ACTIVE_COMPARATOR

Vertebroplasty

Intervention Type: PROCEDURE

Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement

Cavuplasty

This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)

Group Type: EXPERIMENTAL

Cavuplasty

Intervention Type: PROCEDURE

Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection

Interventions

Vertebroplasty

Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement

Intervention Type: PROCEDURE

Cavuplasty

Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification

Exclusion Criteria

• More Than 2 Vertebral Body Fractures
• Fractures of Vertebral Body Based on Malignancy
• Previous Spinal Operation
• Spinal Infection
• Spinal Deformity (scoliosis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohammad ARAB MOTLAGH

OTHER

Sponsor Role: lead

Responsible Party

Mohammad ARAB MOTLAGH

Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohammad Arab Motlagh, MD

Role: STUDY_DIRECTOR

Department of Orthopaedic Surgery University Hospital Frankfurt

Other Identifiers

Cavuplasty

Identifier Type: -

Identifier Source: org_study_id