Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder)NCT03730207
Xpede Clinical Study
A study testing Xpede™ Bone Cement and Mendec Spine Bone Cement in people with Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) and Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder), run by Medtronic Spinal and Biologics at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder), Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)
- What is being tested?
- Xpede™ Bone Cement and Mendec Spine Bone Cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 18 Dec 2018to 14 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Hunan provincial people's hospital
Changsha, Hunan
The first affiliated hospital of Suzhou university
Suzhou, Jiangsu
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan
About this study
Official title: A Prospective, 1: 1 Randomized, Single Blind, Multi-center Human Clinical Trial
The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
- Conditions
- Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder), Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)
- Being tested
- Xpede™ Bone Cement, Mendec Spine Bone Cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpede™ Bone CementDevice
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 CementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Xpede™ Bone Cement | Experimental | 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. Receives: Device: Xpede™ Bone Cement |
| Mendec Spine Bone Cement | Active comparator | 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. Receives: Device: Mendec Spine Bone Cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative
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."
Measured: Baseline and 6 months
The Change of Index Vertebral Body Angle From Baseline at 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.
Measured: Baseline and 6 months
Secondary outcomes (6)
The Change of NRS Score From Baseline at 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."
Measured: Baseline, 1 day, and 3 months
The Change of Oswestry Disability Index (ODI) Score From Baseline at 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).
Measured: Baseline, 1 day, 3 months, and 6 months
The Change of SF-36 From Baseline at 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.
Measured: Baseline, 1 day, 3 months, and 6 months
Change in Vertebral Body Height at 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。
Measured: 1 day, 3 months, and 6 months
Change in Vertebral Body Angle From Baseline at 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.
Measured: Baseline, 1 day and 3 months
Number of Participants With Adverse Events Reported Through 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;
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start18 Dec 2018
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730207
- Sponsor's protocol ID
- MDT17075SD1707
- Status last verified
- Dec 2022
- First submitted
- 16 Oct 2018
- Last updated
- 10 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, 1: 1 Randomized, Single Blind, Multi-center Human Clinical Trial
- ClinicalTrials.gov ID
- NCT03730207
- Acronym / sponsor ID
- MDT17075SD1707
- Conditions
- Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder), Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Posted 10 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xpede™ Bone Cement | Experimental | Device: Xpede™ Bone CementThe 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. |
| Mendec Spine Bone Cement | Active comparator | Device: Mendec Spine Bone CementThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpede™ Bone CementXpede™ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae. | Device | Xpede™ Bone Cement |
| Mendec Spine Bone CementMendec 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. | Device | Mendec Spine Bone Cement |
Primary outcome
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."
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.
6 secondary outcomes
The Change of NRS Score From Baseline at 1 Day and 3 Months
Time frame: Baseline, 1 day, and 3 months
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
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
Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months
Time frame: 1 day, 3 months, and 6 months
Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months
Time frame: Baseline, 1 day and 3 months
Number of Participants With Adverse Events Reported Through 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpede™ Bone Cement and Mendec Spine Bone Cement in people with Pathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) and Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder), run by Medtronic Spinal and Biologics at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023; AzTrials last refreshed its copy on 27 Oct 2026.