Osteoporotic Vertebral Compression FracturesPhase 3NCT00279877
Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial
A Phase 3 study testing Kyphoplasty in people with Osteoporotic Vertebral Compression Fractures, run by University of Virginia at 1 site in United States.
Trial summary
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Osteoporotic Vertebral Compression Fractures
- What is being tested?
- Kyphoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Sep 2011
- Phase
- Phase 3
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- > or = 50 years of age
- Compression fracture (T4-L5)within previous 12 mo.
- Pain from compression fracture
- No malignant tumor
- No back surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.
- Being tested
- Kyphoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KyphoplastyProcedure or surgery
kyphoplasty
| Study group | Role | What they receive |
|---|---|---|
| vertebroplasty | Active comparator | vertebroplasty Receives: Procedure: Kyphoplasty |
| kyphoplasty | Active comparator | kyphoplasty Receives: Procedure: Kyphoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back specific functional status(Roland)
Measured: 12 mo
Pain
Measured: 12 mo
Secondary outcomes (1)
Health status outcome measure(SF-36)
Measured: 12 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startMay 2005
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporotic Vertebral Compression FracturesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Cardinal Health, ArthroCare Corporation, Cook Group Incorporated
- Responsible party
- Principal investigator, Avery Evans, MD, University of Virginia
- Investigators
- Avery Evans, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279877
- Sponsor's protocol ID
- 12031
- Status last verified
- Aug 2016
- First submitted
- 18 Jan 2006
- Last updated
- 18 Aug 2016
- Results posted
- No
Publications
Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.
PubMed 26109687
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial
- ClinicalTrials.gov ID
- NCT00279877
- Acronym / sponsor ID
- 12031
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Cardinal Health, ArthroCare Corporation, Cook Group Incorporated
- Study start
- May 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Jan 2006 (estimated)
- 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.
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vertebroplasty | Active comparator | Procedure: Kyphoplastyvertebroplasty |
| kyphoplasty | Active comparator | Procedure: Kyphoplastykyphoplasty |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Kyphoplastykyphoplasty | Procedure or surgery | kyphoplasty, vertebroplasty |
Primary outcome
Back specific functional status(Roland)
Time frame: 12 mo
Pain
Time frame: 12 mo
1 secondary outcome
Health status outcome measure(SF-36)
Time frame: 12 mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Derived from this study: PubMed 26109687Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.
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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.
Avery Evans, M.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Kyphoplasty in people with Osteoporotic Vertebral Compression Fractures, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Aug 2016. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Back specific functional status(Roland) (time frame: 12 mo). 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?
On the ClinicalTrials.gov record for NCT00279877, which also lists 1 linked publication.
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 18 Aug 2016.