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.

Age range18 Years – 80 Years

SexALL

See this in plain English?

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

✓. 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 .

✕. 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.

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

NCT IDNCT03730207

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-14

Results submitted2022-09-22

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

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

✓. 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 .

✕. 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.