N/A
Completed N=180
Xpede Clinical Study
Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) · Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)
Source: ClinicalTrials.gov NCT03730207 ↗
Enrolled (actual)
180
Serious AEs
1.1%
Results posted
Jan 2023
Primary outcomePrimary: The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative — -4.2; -4.4 score
Summary
The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative |
-4.2; -4.4 | — |
| PRIMARY The Change of Index Vertebral Body Angle From Baseline at 6 Months |
-0.869; -0.952 | — |
| SECONDARY The Change of NRS Score From Baseline at 1 Day and 3 Months |
-2.9; -2.3; -3.6; -3.8 | — |
| SECONDARY The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months |
-26.407; -29.108; -26.407; -29.108; -1.757; 1.746 | — |
| SECONDARY The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months |
3.781; -1.436; 5.740; 0.086; 0.650; 0.809 | — |
| SECONDARY Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months |
-4.271; -4.429; -3.949; -4.154; -2.514; -2.738 | — |
| SECONDARY Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months |
-1.710; -1.662; -2.739; -2.375 | — |
| SECONDARY Number of Participants With Adverse Events Reported Through 6 Months |
28; 32 | — |
Eligibility Criteria
Inclusion Criteria
- Subject being diagnosed as having painful pathological vertebral body fracture, who is suitable for VP/BKP procedure (1-3 levels) according to clinic practice.
- Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
- Subjects are at least 18 and ≤80 years old .
Exclusion Criteria
- Subject has a local or systemic infection.
- Subject has pains caused by other spine disease than painful pathological vertebral compression fracture.
- Subject has a medical condition with less than 1 year of life expectancy.
- Subject is grossly obese, i.e. BMI≥40.
- Subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision.
- Subject has an allergy or an intolerance to bone cement component.
- Subject has past spinal surgeries at the target level(s) for which the VP/BKP procedure is suitable.
- Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager and Medtronic Medical Advisor.
- Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence.
- Subjects with exclusion criteria required by local law (age or other).
- Subjects with medical condition which precludes them from participation in the opinion of the Investigator.
Data sourced from ClinicalTrials.gov (NCT03730207). 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.