OsteopeniaPhase 4NCT00211211
FREE Study - Fracture Reduction Evaluation
A Phase 4 study testing Balloon Kyphoplasty in people with Osteopenia and Osteoporosis, run by Medtronic Spine LLC at 1 site in United States.
Trial summary
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteopenia, Osteoporosis, Multiple Myeloma
- What is being tested?
- Balloon Kyphoplasty
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Dec 2007
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum of one painful, acute (edema present on MRI obtained within a two weeks period prior to enrolment) thoracic or lumbar (T5-L5) vertebral body compression fracture, due to osteopenia arising from primary or secondary osteoporosis, multiple myeloma, or osteolytic metastatic tumors and maximum of three painful fractures requiring treatment. (NOTE: a T2-weighted MRI should be done unless it is not available);
- Minimum of one acute fracture to be treated that has height loss > 15% of predicted height (average height of two adjacent "normal" vertebrae) when measured at the middle of the vertebral endplate. (NOTE: If the adjacent vertebrae are not normal, the predicted height will be based on the height listed for the fractured vertebra in the table taken from Black et al.)
- Pre-treatment VAS score > 4 on a scale of 10 where 0 is no pain, 5 is moderate pain and 10 is pain "as bad as you can imagine";
- Patient 21 years of age or older;
- The investigator and surgeon/radiologist agree before randomization that the fracture(s) can technically be reduced using an inflatable bone tamp (IBT); and
- A signed Informed Consent is obtained from the patient.
Who cannot join
- Previous vertebroplasty;
- Vertebral body fracture morphology prevents use of devices (such as endplate below pedicles);
- Pedicle fractures;
- Acute fracture(s) to be treated symptomatic > 3 months at enrollment;
- Pre-existing (not the result of the index fracture) neurological deficit or radicular pain that is not well defined or unstable;
- Spinal cord compression or canal compromise requiring decompression;
Show all 19Show fewer
- Disabling back pain secondary to causes other than acute fracture;
- Vertebral fracture due to primary or osteoblastic tumors;
- Patient is currently on anticoagulation therapy that can not be interrupted;
- Pre-existing conditions contrary to the kyphoplasty procedure:
- Systemic infection
- Local fractured vertebral body infection
- Temporarily non-reversible bleeding disorder
- Known allergy to any of the drugs, bone void filler material or contrast medium used in the treatment of study subjects
- Dementia and/or inability to give informed consent;
- Inability to walk or stand prior to the vertebral body fracture (walking aids are allowed);
- MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis);
- Pregnancy
- Participation in any other clinical trial within the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An International Multicentric, Multidisciplinary Prospective and Randomized Study to Compare Minimally Invasive Reduction and Fixation Using the KyphX System and Radiopaque PMMA Cement to Medical Therapy Alone for the Treatment of Painful, Acute Osteopenic Vertebral Body Compression Fractures
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.
- Conditions
- Osteopenia, Osteoporosis, Multiple Myeloma, Bone Neoplasms
- Being tested
- Balloon Kyphoplasty
- Keywords
- Osteopenia, Osteoporosis, Multiple Myeloma, Osteolytic Metastatic Tumors, Vertebral Compression Fracture, Back Pain, Spine
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Multiple Myeloma, Bone Neoplasms, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon KyphoplastyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral compression fractures (VCFs).
Safety will be compared between the study groups throughout the study with focus on clinically meaningful events and subsequent VCFs including the "treated" vertebrae.
The primary study endpoint is the change in quality of life as measured by the Physical Component Summary (PCS) scale of the 36-Item Short Form (SF-36) as measured at the one-month follow-up visit.
Secondary outcomes (12)
The secondary study endpoints are: EuroQol self-report (EQ-5D) questionnaire and SF-36 scores at 1, 3, 6, 12 and 24 months
procedural safety (peri-operative clinical events)
function as measured by objective functionality tests-reaching, "get up and go" and by the subjective Roland Morris disability questionnaire at 1, 3, 6, 12 and 24 months
pain using a 10-point visual analogue scale (VAS) at 5-10 days (post enrollment for the control group and post kyphoplasty for the kyphoplasty group)
changes in spinal deformity as measured radiographically at baseline, 3, 12 and 24 months.
Maintenance of vertebral body height will be assessed from lateral spine x-rays obtained in Kyphoplasty treated subjects only at baseline and at 3, 12, and 24 month visits.
patient satisfaction at 1, 3, 6, 12, 24 months
outcome (nursing home, back to status prior to fracture) at 1, 3, 6, 12, 24 months
economic aspects (including hospital days, disabilities, etc.) at 1, 3, 6, 12, 24 months
the cost-effectiveness of kyphoplasty expressed in incremental cost/quality adjusted life year gained at different time points (1 year and 2 years)
rate of incident fractures at 3, 12 and 24 months (frequency, timing and location)
Each endpoint will be compared between the 2 groups and for its evolution over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Spine LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Johnell, MD, Principal investigator, UMRA - Malmo, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211211
- Sponsor's protocol ID
- SP0201 - FREE Study
- Status last verified
- Jan 2012
- First submitted
- 13 Sep 2005
- Last updated
- 8 Dec 2017
- Results posted
- No
Publications
Van Meirhaeghe J, Bastian L, Boonen S, Ranstam J, Tillman JB, Wardlaw D; FREE investigators. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine (Phila Pa 1976). 2013 May 20;38(12):971-83. doi: 10.1097/BRS.0b013e31828e8e22.
PubMed 23446769Ranstam J, Turkiewicz A, Boonen S, Van Meirhaeghe J, Bastian L, Wardlaw D. Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE). BMC Med Res Methodol. 2012 Mar 24;12:35. doi: 10.1186/1471-2288-12-35.
PubMed 22443312Fritzell P, Ohlin A, Borgstrom F. Cost-effectiveness of balloon kyphoplasty versus standard medical treatment in patients with osteoporotic vertebral compression fracture: a Swedish multicenter randomized controlled trial with 2-year follow-up. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2243-51. doi: 10.1097/BRS.0b013e3182322d0f.
PubMed 21912321Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009 Mar 21;373(9668):1016-24. doi: 10.1016/S0140-6736(09)60010-6. Epub 2009 Feb 24.
PubMed 19246088
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicentric, Multidisciplinary Prospective and Randomized Study to Compare Minimally Invasive Reduction and Fixation Using the KyphX System and Radiopaque PMMA Cement to Medical Therapy Alone for the Treatment of Painful, Acute Osteopenic Vertebral Body Compression Fractures
- ClinicalTrials.gov ID
- NCT00211211
- Acronym / sponsor ID
- SP0201 - FREE Study
- Conditions
- Osteopenia, Osteoporosis, Multiple Myeloma, Bone Neoplasms
- Keywords
- Osteopenia, Osteoporosis, Multiple Myeloma, Osteolytic Metastatic Tumors, Vertebral Compression Fracture, Back Pain, Spine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Medtronic Spine LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Sep 2005 (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.
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum of one painful, acute (edema present on MRI obtained within a two weeks period prior to enrolment) thoracic or lumbar (T5-L5) vertebral body compression fracture, due to osteopenia arising from primary or secondary osteoporosis, multiple myeloma, or osteolytic metastatic tumors and maximum of three painful fractures requiring treatment. (NOTE: a T2-weighted MRI should be done unless it is not available);
- Minimum of one acute fracture to be treated that has height loss > 15% of predicted height (average height of two adjacent "normal" vertebrae) when measured at the middle of the vertebral endplate. (NOTE: If the adjacent vertebrae are not normal, the predicted height will be based on the height listed for the fractured vertebra in the table taken from Black et al.)
- Pre-treatment VAS score > 4 on a scale of 10 where 0 is no pain, 5 is moderate pain and 10 is pain "as bad as you can imagine";
- Patient 21 years of age or older;
- The investigator and surgeon/radiologist agree before randomization that the fracture(s) can technically be reduced using an inflatable bone tamp (IBT); and
Key exclusion criteria (19 listed)
- Previous vertebroplasty;
- Vertebral body fracture morphology prevents use of devices (such as endplate below pedicles);
- Pedicle fractures;
- Acute fracture(s) to be treated symptomatic > 3 months at enrollment;
- Pre-existing (not the result of the index fracture) neurological deficit or radicular pain that is not well defined or unstable;
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 |
|---|---|---|
| Balloon Kyphoplasty | Device | – |
Primary outcome
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral compression fractures (VCFs).
Safety will be compared between the study groups throughout the study with focus on clinically meaningful events and subsequent VCFs including the "treated" vertebrae.
The primary study endpoint is the change in quality of life as measured by the Physical Component Summary (PCS) scale of the 36-Item Short Form (SF-36) as measured at the one-month follow-up visit.
12 secondary outcomes
The secondary study endpoints are: EuroQol self-report (EQ-5D) questionnaire and SF-36 scores at 1, 3, 6, 12 and 24 months
procedural safety (peri-operative clinical events)
function as measured by objective functionality tests-reaching, "get up and go" and by the subjective Roland Morris disability questionnaire at 1, 3, 6, 12 and 24 months
pain using a 10-point visual analogue scale (VAS) at 5-10 days (post enrollment for the control group and post kyphoplasty for the kyphoplasty group)
changes in spinal deformity as measured radiographically at baseline, 3, 12 and 24 months.
Maintenance of vertebral body height will be assessed from lateral spine x-rays obtained in Kyphoplasty treated subjects only at baseline and at 3, 12, and 24 month visits.
patient satisfaction at 1, 3, 6, 12, 24 months
outcome (nursing home, back to status prior to fracture) at 1, 3, 6, 12, 24 months
economic aspects (including hospital days, disabilities, etc.) at 1, 3, 6, 12, 24 months
the cost-effectiveness of kyphoplasty expressed in incremental cost/quality adjusted life year gained at different time points (1 year and 2 years)
rate of incident fractures at 3, 12 and 24 months (frequency, timing and location)
Each endpoint will be compared between the 2 groups and for its evolution over time.
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 8 Dec 2017.
- Derived from this study: PubMed 23446769Van Meirhaeghe J, Bastian L, Boonen S, Ranstam J, Tillman JB, Wardlaw D; FREE investigators. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine (Phila Pa 1976). 2013 May 20;38(12):971-83. doi: 10.1097/BRS.0b013e31828e8e22.
- Derived from this study: PubMed 22443312Ranstam J, Turkiewicz A, Boonen S, Van Meirhaeghe J, Bastian L, Wardlaw D. Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE). BMC Med Res Methodol. 2012 Mar 24;12:35. doi: 10.1186/1471-2288-12-35.
- Derived from this study: PubMed 21912321Fritzell P, Ohlin A, Borgstrom F. Cost-effectiveness of balloon kyphoplasty versus standard medical treatment in patients with osteoporotic vertebral compression fracture: a Swedish multicenter randomized controlled trial with 2-year follow-up. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2243-51. doi: 10.1097/BRS.0b013e3182322d0f.
- Derived from this study: PubMed 19246088Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009 Mar 21;373(9668):1016-24. doi: 10.1016/S0140-6736(09)60010-6. Epub 2009 Feb 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.
Prof. Johnell, MD principal investigator
UMRA - Malmo, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Balloon Kyphoplasty in people with Osteopenia and Osteoporosis, run by Medtronic Spine LLC 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?
The sponsor lists 6 inclusion and 19 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 8 Dec 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral compression fractures (VCFs).. The study lists 3 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 NCT00211211, which also lists 4 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 8 Dec 2017.