Spinal FracturesNCT03360383
Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures
A study testing percutaneous vertebroplasty and conservative treatment in people with Spinal Fractures, run by Peking University People's Hospital.
Trial summary
Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- percutaneous vertebroplasty and conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- vertebral compression fracture on spine radiograph (minimum 15% height loss)
- level of fracture at Th5 or lower; back pain for 6 weeks or less
- focal tenderness at fracture level on physical examination
- bone oedema of vertebral fracture on MRI
- decreased bone density (T scores ≤-1)
Who cannot join
- severe cardiopulmonary comorbidity
- suspected underlying malignant disease
- radicular syndrome
- spinal-cord compression syndrome
- contraindication for radiography exam
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures: a Multiple Center Randomized Controlled Trial
Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.
Read the detailed description
This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods.
Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.
- Conditions
- Spinal Fractures
- Being tested
- percutaneous vertebroplasty, conservative treatment
- Keywords
- Spinal Fractures/surgery, Vertebroplasty, Quality-Adjusted Life Years
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous vertebroplastyProcedure or surgery
Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.
conservative treatmentProcedure or surgery
complete on bed with prevention of complications
| Study group | Role | What they receive |
|---|---|---|
| grade 1 | Experimental | percutaneous vertebroplasty Receives: Procedure: percutaneous vertebroplasty |
| grade 2 | Active comparator | conservative treatment Receives: Procedure: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain relief
World Health Organization pain classification
Measured: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
Secondary outcomes (1)
quality of life
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
Measured: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Feb 2018 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Haiying, Peking University People's Hospital
- Investigators
- haiying liu, Study director, PekingUPH department of spinal surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360383
- Sponsor's protocol ID
- AVCF1
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Essentiality of Vertebroplasty Surgery in Acute Vertebral Compression Fractures: a Multiple Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03360383
- Acronym / sponsor ID
- AVCF1
- Conditions
- Spinal Fractures
- Keywords
- Spinal Fractures/surgery, Vertebroplasty, Quality-Adjusted Life Years
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.
Detailed description
This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods.
Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| grade 1 | Experimental | Procedure: percutaneous vertebroplastypercutaneous vertebroplasty |
| grade 2 | Active comparator | Procedure: conservative treatmentconservative treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- vertebral compression fracture on spine radiograph (minimum 15% height loss)
- level of fracture at Th5 or lower; back pain for 6 weeks or less
- focal tenderness at fracture level on physical examination
- bone oedema of vertebral fracture on MRI
- decreased bone density (T scores ≤-1)
Key exclusion criteria (5 listed)
- severe cardiopulmonary comorbidity
- suspected underlying malignant disease
- radicular syndrome
- spinal-cord compression syndrome
- contraindication for radiography exam
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 |
|---|---|---|
| percutaneous vertebroplastyUndertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement. | Procedure or surgery | grade 1 |
| conservative treatmentcomplete on bed with prevention of complications | Procedure or surgery | grade 2 |
Primary outcome
change of pain relief
Time frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
World Health Organization pain classification
1 secondary outcome
quality of life
Time frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: No
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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.
haiying liu study director
PekingUPH department of spinal surgery
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous vertebroplasty and conservative treatment in people with Spinal Fractures, run by Peking University People's Hospital.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chen guo (8618055644700, fantasy_g@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of pain relief (time frame: 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year). 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 5 Dec 2017.