Clinical trial NCT03730207: Xpede Clinical Study
Official title: A Prospective, 1: 1 Randomized, Single Blind, Multi-center Human Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder)
Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2018-11-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative
timeFrame: Baseline and 6 months
measure: The Change of Index Vertebral Body Angle From Baseline at 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: The Change of NRS Score From Baseline at 1 Day and 3 Months
timeFrame: Baseline, 1 day, and 3 months
measure: The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months
timeFrame: Baseline, 1 day, 3 months, and 6 months
measure: The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months
timeFrame: Baseline, 1 day, 3 months, and 6 months
measure: Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months
timeFrame: 1 day, 3 months, and 6 months
measure: Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months
timeFrame: Baseline, 1 day and 3 months
measure: Number of Participants With Adverse Events Reported Through 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou university
state: Henan
city: Changsha
country: China
facility: Hunan provincial people's hospital
state: Hunan
city: Suzhou
country: China
facility: The first affiliated hospital of Suzhou university
state: Jiangsu
Study officials:
References: