Xpede Clinical Study

Medtronic

Status: Completed

Conditions: Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder); Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder)

Treatments: Device: Xpede™ Bone Cement; Device: Mendec Spine Bone Cement

Study type: Interventional

Funder types: Industry

Identifiers

NCT03730207

MDT17075SD1707

Details and patient eligibility

About

The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Xpede™ Bone Cement

Experimental group

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.

Treatment:

Device: Xpede™ Bone Cement

Mendec Spine Bone Cement

Active Comparator group

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.

Treatment:

Device: Mendec Spine Bone Cement