A Dutch Prospective, Multi-disciplinary, Multicentric And Randomized Study To Compare Minimally Invasive Reduction and Fixation Using The Kyphx-System And Radiopaque PMMA Cement To Non surgical Therapy Alone For The Treatment of Painful, Acute Osteopenic Vertebral Body Compression Fractures

Phase 4

Withdrawn

• Conditions: osteopenia - porous bone; 10017322; 10005944

• Registration Number: NL-OMON30930
• Lead Sponsor: Hilversum Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

-Minimum of one and maximum of three painful, acute (edema present on MRI obtained within a one month period prior to enrolment) vertebral body compression fractures due to osteopenia arising from osteoporosis, multiple myeloma or osteolytic metastatic tumors.
-Pre-treatment VAS score of 4 or more on scale 0 (no pain) - 10 (worst imaginable pain)
-21 years of age or older
-balloon kyphoplasty is technically feasible
-a signed Informed constent has been obtained from the patient

Exclusion Criteria

-pedicle fractures
-pre-existing neurological deficit or radicular pain
-Spinal cord compression or canal compromise requiring decompression
-Disabling back pain secondary to causes other than the fractures
-pre-existing contraindications to surgery in general, to MRI or known allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in quality of life as measured by the EQ-5D at 7 days compared to at<br /><br>baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Following variables will be compared to at baseline:<br /><br>Pain using the VAS score (at 7days, 6 weeks, 4 & 12 months), EQ-5D (at 6 weeks<br /><br>and 4 & 12 months), Qualeffo (at 6 weeks adn 12 months) and an economic<br /><br>questionnaire (at 4 & 12 months)</p><br>