CompletedNot Applicable

Xpede Clinical Study

China180 participantsStarted 2018-12-18

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative

Timeframe: Baseline and 6 months

The Change of Index Vertebral Body Angle From Baseline at 6 Months

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT03730207

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-14

Results submitted2022-09-22

View on ClinicalTrials.gov More Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) trials