Compression Fracture SpineNCT03451305
Postrual Reduction With Pillow in Osteoporotic Vertebral Fracture
A study testing Pillow in people with Compression Fracture Spine and Osteoporosis Fracture, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Compression Fracture Spine, Osteoporosis Fracture
- What is being tested?
- Pillow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jan 2018to 23 May 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single level osteoporotic compression fracture of thoracic and lumbar spine
Who cannot join
- Can't tolerate the postural reduction by pillow
- Pathological spine fracture caused by tumor, infection.
- Multiple spine fractures
- Patient presented with neurological. deficits
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Ming-Chau Chang, M.D., 886-2-28717557 ext. 9, mcchang@vghtpe.gov.tw
About this study
Official title: Postrual Reduction With Pillow in Osteoporotic Vertebral Fractures: a Randomized, Prospective Study
Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.
- Conditions
- Compression Fracture Spine, Osteoporosis Fracture
- Being tested
- Pillow
- Keywords
- Compression fracture, postural reduction, vertebroplasty
- Medical subject headings
- Osteoporotic Fractures, Fractures, Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillowOther
A soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position
| Study group | Role | What they receive |
|---|---|---|
| Pillow group | Experimental | Before surgery, with the patient lying in the supine position, a soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position. 12 hours duration suggested from 11:00 pm 1 night before the surgery till next day. Receives: Other: Pillow |
| No pillow group | No intervention | No intervention was given in this group before surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sagittal plane contour
Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs
Measured: 6 months of post-operative follow up
Secondary outcomes (1)
Functional outcome
Visual Analogue Scale This is a pain scale, 10 scoes is the worest pain ever. 0 scores is no pain
Measured: 6 months of post-operative follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start23 Jan 2018
- Primary completion23 May 2019 (estimated)
- Study completion23 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Compression Fracture SpineStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Single group
- Model description
- Patients with single level osteoporotic compression fracture
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451305
- Sponsor's protocol ID
- 2017-05-005C
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rao RD, Singrakhia MD. Painful osteoporotic vertebral fracture. Pathogenesis, evaluation, and roles of vertebroplasty and kyphoplasty in its management. J Bone Joint Surg Am. 2003 Oct;85(10):2010-22. No abstract available.
PubMed 14563813Lee JH, Lee DO, Lee JH, Lee HS. Comparison of radiological and clinical results of balloon kyphoplasty according to anterior height loss in the osteoporotic vertebral fracture. Spine J. 2014 Oct 1;14(10):2281-9. doi: 10.1016/j.spinee.2014.01.028. Epub 2014 Jan 23.
PubMed 24462536Chin DK, Kim YS, Cho YE, Shin JJ. Efficacy of postural reduction in osteoporotic vertebral compression fractures followed by percutaneous vertebroplasty. Neurosurgery. 2006 Apr;58(4):695-700; discussion 695-700. doi: 10.1227/01.NEU.0000204313.36531.79.
PubMed 16575333
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postrual Reduction With Pillow in Osteoporotic Vertebral Fractures: a Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT03451305
- Acronym / sponsor ID
- 2017-05-005C
- Conditions
- Compression Fracture Spine, Osteoporosis Fracture
- Keywords
- Compression fracture, postural reduction, vertebroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 23 May 2019 (estimated)
- Study completion
- 23 May 2019 (estimated)
- First posted
- 1 Mar 2018 (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.
Vertebroplasty in the symptomatic osteoporotic vertebral fracture has become increasingly popular. However, there have been some limitations in restoring the height of the collapsed vertebrae and in preventing the leaking of cement. In the severely collapsed vertebrae of more than two thirds of their original height, vertebroplasty is regarded as a contraindication. We tried postural reduction using a soft pillow under the compressed level. This study was undertaken to investigate the effectiveness of the combination of postural reduction and vertebroplasty for re-expansion and stabilization of the osteoporotic vertebral fractures. single level vertebral compression fracture were treated with postural reduction followed by vertebroplasty. We analyzed the degree of re-expansion according to the onset duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients with single level osteoporotic compression fracture
| Arm | Type | Receives |
|---|---|---|
| Pillow group | Experimental | Other: PillowBefore surgery, with the patient lying in the supine position, a soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position. 12 hours duration suggested from 11:00 pm 1 night before the surgery till next day. |
| No pillow group | No intervention | –No intervention was given in this group before surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Single level osteoporotic compression fracture of thoracic and lumbar spine
Key exclusion criteria (4 listed)
- Can't tolerate the postural reduction by pillow
- Pathological spine fracture caused by tumor, infection.
- Multiple spine fractures
- Patient presented with neurological. deficits
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 |
|---|---|---|
| PillowA soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position | Other | Pillow group |
Primary outcome
Sagittal plane contour
Time frame: 6 months of post-operative follow up
Sagittal plane measurement by measuring the Cobb angle of the injured vertebral on lateral radio-graphs
1 secondary outcome
Functional outcome
Time frame: 6 months of post-operative follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Background: PubMed 14563813Rao RD, Singrakhia MD. Painful osteoporotic vertebral fracture. Pathogenesis, evaluation, and roles of vertebroplasty and kyphoplasty in its management. J Bone Joint Surg Am. 2003 Oct;85(10):2010-22. No abstract available.
- Background: PubMed 24462536Lee JH, Lee DO, Lee JH, Lee HS. Comparison of radiological and clinical results of balloon kyphoplasty according to anterior height loss in the osteoporotic vertebral fracture. Spine J. 2014 Oct 1;14(10):2281-9. doi: 10.1016/j.spinee.2014.01.028. Epub 2014 Jan 23.
- Results publication: PubMed 16575333Chin DK, Kim YS, Cho YE, Shin JJ. Efficacy of postural reduction in osteoporotic vertebral compression fractures followed by percutaneous vertebroplasty. Neurosurgery. 2006 Apr;58(4):695-700; discussion 695-700. doi: 10.1227/01.NEU.0000204313.36531.79.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pillow in people with Compression Fracture Spine and Osteoporosis Fracture, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 inclusion and 4 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Chau Chang, M.D. (886-2-28717557 ext. 9, mcchang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sagittal plane contour (time frame: 6 months of post-operative follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451305, which also lists 3 linked publications.
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 1 Mar 2018.