Clinical trial · Interventional
Xpede Clinical Study
A Prospective, 1: 1 Randomized, Single Blind, Multi-center Human Clinical Trial
NCT03730207CI-TRIAL-00063113completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder) | — | UNRESOLVED | — |
| Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mendec Spine Bone Cement | Device | — | UNRESOLVED |
| Xpede™ Bone Cement | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Xpede™ Bone Cement
- description
- The subjects in this group will be injected the Xpede™ Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body.
- interventionNames
- Device: Xpede™ Bone Cement
- type
- ACTIVE_COMPARATOR
- label
- Mendec Spine Bone Cement
- description
- The subjects in this group will be injected the Mendec Spine Bone Cement into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body.
- interventionNames
- Device: Mendec Spine Bone Cement
Primary outcomes (2)
- measure
- The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject being diagnosed as having painful pathological vertebral body fracture, who is suitable for VP/BKP procedure (1-3 levels) according to clinic practice. 2. 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. 3. Subjects are at least 18 and ≤80 years old . Exclusion Criteria: 1. Subject has a local or systemic infection. 2. Subject has pains caused by other spine disease than painful pathological vertebral compression fracture. 3. Subject has a medical condition with less than 1 year of life expectancy. 4. Subject is grossly obese, i.e. BMI≥40. 5. Subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision. 6. Subject has an allergy or an intolerance to bone cement component. 7. Subject has past spinal surgeries at the target level(s) for which the VP/BKP procedure is suitable. 8. 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. 9. Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence. 10. Subjects with exclusion criteria required by local law (age or other). 11. Subjects with medical condition which precludes them from participation in the opinion of the Investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.