Phase 4
Completed N=84
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Source: ClinicalTrials.gov NCT01383616 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups — 15; 14 units on a scale — p=0.85
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups |
15; 14 | 0.85 |
| PRIMARY Change in RDQ in the Bipedicular Group From 3 to 12 Months |
4.7 | 0.008 sig |
| SECONDARY Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty |
20.5; 14.8 | 0.17 |
| SECONDARY Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty |
4.80; 4.70 | 0.93 |
| SECONDARY Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups |
11.2; 8.1 | 0.17 |
| SECONDARY Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups |
4.3; 3.9 | 0.67 |
| SECONDARY Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups |
14.8; 14.1 | 0.90 |
| SECONDARY Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups |
8.1; 6.7 | 0.36 |
| SECONDARY Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups |
3.7; 3.5 | 0.87 |
| SECONDARY Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty |
17.8; 13.7 | 0.24 |
Eligibility Criteria
Inclusion Criteria
- Males or females older than 50 years of age with acute vertebral compression fractures causing significant pain and functional limitations in their daily activities.
Exclusion Criteria
- primary tumors of bone or evidence of metastasis at the index vertebrae
- pre-existing chronic pain or functional disability unrelated to a vertebral compression fracture which would confound the data analysis
- fracture secondary to a traumatic event
- inability to fully visualize both pedicles of the fractured vertebrae on intraoperative fluoroscopy
Data sourced from ClinicalTrials.gov (NCT01383616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.