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OpenTrials
Completed

NCT Number: NCT03730207

Xpede Clinical Study

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first affiliated hospital of Zhengzhou university, Zhengzhou, Henan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence.
  • Subjects with exclusion criteria required by local law (age or other).
  • Subjects with medical condition which precludes them from participation in the opinion of the Investigator.

Treatment and study plan

Xpede™ Bone Cement

Device

Xpede™ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.

Mendec Spine Bone Cement

Device

Mendec Spine Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.

Primary outcomes

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

    Time frame: Baseline and 6 months

    NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

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

    Time frame: Baseline and 6 months

    Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.

Secondary outcomes

  1. The Change of NRS Score From Baseline at 1 Day and 3 Months

    Time frame: Baseline, 1 day, and 3 months

    NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

  2. The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months

    Time frame: Baseline, 1 day, 3 months, and 6 months

    ODI Questionnaire is used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

  3. The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months

    Time frame: Baseline, 1 day, 3 months, and 6 months

    The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS/MCS is between 0 and 100, with higher scores denoting better quality of life.

  4. Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months

    Time frame: 1 day, 3 months, and 6 months

    Vertebral Body Height in the lateral projection will be measured at each treated vertebra as well as the next adjacent vertebrae (superior and inferior) without fracture and reported in millimeters.

    Vertebral Body Height is the distance between comparable points on the superior and inferior endplates of the vertebral body at the posterior (Hp), midline (Hm) and anterior (Ha) locations。

  5. Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months

    Time frame: Baseline, 1 day and 3 months

    Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.

  6. Number of Participants With Adverse Events Reported Through 6 Months

    Time frame: 6 months

    Adverse events reported through 6 months, in particular, the following events will be reported:

    • Bone Cement Implantation Syndrome;
    • Bone Cement leakage;
    • Vertebral body compression fracture;
    • Adjacent vertebral body fracture;

Sponsors and collaborators

Lead sponsor

Medtronic Spinal and Biologics

Industry

Registry information

Official study title

A Prospective, 1: 1 Randomized, Single Blind, Multi-center Human Clinical Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2018
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.