Efficacy of Kyphoplasty With a New Intervertebral Expander

• Sponsor: Mohammad ARAB MOTLAGH (Other)
• Overall Status: Completed
• CT.gov ID: NCT03521661
• Collaborator: (none)
• Enrollment: 41
• Actual Duration (Months): 49.9

Study Details

Study Description

Brief Summary

Balloon kyphoplasty is a well-established treatment option to achieve pain relief and to correct kyphotic deformity caused by osteoporotic vertebral compression fracture. However, it has been demonstrated that reduction is partly lost as balloon is deflated in the vertebral body. An intravertebral expander was developed for better reduction and maintenance of vertebral body height while cement is injected. This study evaluates the efficacy of kyphoplasty with a new intravertebral expander with regard to correction of kyphosis angel and to restoration of vertebral body height.

Condition or Disease	Intervention/Treatment	Phase
Vertebral Body Compression	Procedure: Kyphoplasty

Study Design

• Study Type: Observational
• Actual Enrollment: 41 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Efficacy of Kyphoplasty With an Intravertebral Expander for Correction of Spine Deformity After Osteoporotic Vertebral Fracture
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Kyphoplasty Patients underwent kyphoplasty with an intravertebral expander	Procedure: Kyphoplasty; Fractured vertebral body was reduced with an intravertebral expander and was cement augmented thereafter

Outcome Measures

Primary Outcome Measures

1. Radiological evaluation [12 months]

   Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray

Secondary Outcome Measures

1. Visual Analogue Scale [12 months]

   Scores range from 0 (no pain) to 10 (worst possible pain)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Osteoporotic vertebral body fractures 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mohammad ARAB MOTLAGH

Investigators

• Principal Investigator: Mohammad Arab Motlagh, MD, PhD, University Hospital Frankfurt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammad ARAB MOTLAGH, MD PhD, Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT03521661
• Other Study ID Numbers: Kyphoplasty
• First Posted: May 11, 2018
• Last Update Posted: May 22, 2018
• Last Verified: May 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohammad ARAB MOTLAGH, MD PhD, Johann Wolfgang Goethe University Hospital: Vertebral fracture; Kyphotic deformity; Kyphoplasty; Vertebroplasty

Study Results

No Results Posted as of May 22, 2018