At a glance
ClinicalIndex Comparison Record- ✓1 to 3 painful vertebral compression fractures between T5-L5 with bone marrow edema on MRI or fracture on plain radiographs
- ✓Pain score ≥4 on 0-10 numeric rating scale
- ✓Roland Morris Disability Questionnaire score ≥10 on 0-24 scale
- ✓Age ≥21 years
- ✕Primary bone tumors (e.g. osteosarcoma) or solitary plasmacytoma at the index fracture site
- ✕Concurrent Phase I investigational anti-cancer treatment
- ✕Osteoblastic tumors at the site of index vertebral compression fracture
- ✕Spinal cord compression or canal compromise requiring decompression
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients
In Brief
A clinical study evaluating Balloon Kyphoplasty and Non Surgical Management for Cancer and Spinal Fractures. Completed, enrolled 134 participants across 20 sites in 8 countries.
Detailed Summary
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.
Study Details
Timeline
Interventions
Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.
Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.