Vertebral FractureKYPHOKNCT00748631
Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.
A study testing balloon kyphoplasty in people with Vertebral Fracture and Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Fracture, Multiple Myeloma, Osteolytic Metastases
- What is being tested?
- balloon kyphoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2007to Nov 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years or older
- 1 to 3 vertebral compression fracture(s), between T5-L5, responding to the following criteria:
- at least 15% loss of vertebral body height (anterior, median or posterior);
- malignant origin (bone metastases, multiple myeloma, hemopathy) assessed by imaging, including an MRI and a CT-SCAN of less than 4 weeks.
- Pain or painful deterioration less than 3 months old, related to one or more vertebral fractures with a VAS higher than 50/100 mm when changing position, or higher than 40/100 mm if associated with morphine ≥ 30 mg/day ;
- The pain related to the fractured vertebrae is the more prevalent
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- More than 3 months life expectancy.
- Blood Platelets rate more than or equal to 50 000/mm3 within the week before balloon kyphoplasty procedure (after a correct blood transfusion).
- Patient must have signed a consent form.
- Patient affiliated to social security
Who cannot join
- Patient younger than 18
- Impossibility to perform Balloon Kyphoplasty:
- Technical impossibility to achieve the percutaneous approach to the vertebra to treat.
- Vertebral pedicle diameter or height of treated vertebra(e) not sufficient regarding balloon kyphoplasty TROCATHETER size. This should be assessed through prescreening MRI and/or CT-Scan
- More than three symptomatic vertebral compression fractures in the same vertebral segment.
- Patient receiving additional local treatment within 15 days after balloon kyphoplasty procedure (surgery, radiofrequency, radiotherapy).
Show all 17Show fewer
- Patient with primary bone tumors (eg : osteosarcoma) or single solitary plasmocytoma (patients presenting those tumors on other parts of the body, other than VCF are eligible).
- Patients presenting sclerotic or mixed vertebral lesions(sclerotic vertebral lesions at another vertebral level are not a contraindication).
- Patients with less than 3 month life expectancy
- Patient undergoing an experimental anti-cancerous treatment in Phase I evaluated at the same time
- Patient having relevant co-morbidities which may interfere with the data management on pain and quality of life.
- Patient presenting an inadequate vertebra with Balloon Kyphoplasty.
- Patient undergoing an additional treatment other than balloon kyphoplasty for their vertebral fracture.
- Patient presenting neurological signs or spinal cord compression or spinal canal narrowing requiring surgical decompression;
- Patient with a medical or surgical condition not compatible with balloon kyphoplasty procedure (eg : a non-treated local infection)
- Patient having an allergy to the bone cement and/or to the contrast media used during the balloon kyphoplasty procedure.
- Pregnant or breast feeding women
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Henri Mondor - Service de Radiologie
Créteil, Val de Marne, 94000
Hôpital Lariboisière-service de radiologie ostéoarticulaire
Paris, 75010
Hôpital Cochin - service de radiologie
Paris, 75014
Hopital Bichat -service de radiologie
Paris, 75018
About this study
Official title: Assessment of Percutaneous Balloon Kyphoplasty in the Treatment of Malignant Vertebral Fractures (Multiple Myeloma and Osteolytic Metastases) : "Observational Study"
Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications.
This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure.
Read more
Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient.
The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.
Read the detailed description
Vertebral compression fractures (VCF) represent an important source of morbidity in patients presenting osteolytic metastatic or myelomatous vertebral involvement. In addition, cancer treatments may induce osteoporosis with an additional risk of vertebral fractures.
- Current medical treatments are symptomatic. They do not treat the fracture itself.
- Vertebroplasty is an interventional radiological technique that consists of injecting, percutaneously, acrylic cement into the fractured vertebra under radiological guidance and local or general anaesthesia, in order to combine two effects: stabilization of the vertebral body fracture and pain reduction.
- Balloon Kyphoplasty is a variant of vertebroplasty which is performed using the KyphX® System (Medtronic., Sunnyvale, California). Balloon kyphoplasty aims at restore vertebral height of the fractured vertebra using an inflatable balloon prior to inject surgical polymethylmetacrylate (PMMA)cement,into the vertebral body to fix the fracture. It is an expensive technique costing around 4,000 euros for up to 2 vertebrae in the same patient. The surgical technique for the procedure has been described by LIBERMEAN et al: A bilateral approach is usually chosen to insert working cannulas into the posterior part of the vertebral body through a posterior transpedicular approach. In case of limited and asymmetric vertebral destruction, a single unilateral approach may be preferred. Fluoroscopy is used to insert the tools and control the procedure. With reaming tools, two working channels are created and the balloons are inserted. The balloons are available in lengths of 10, 15 and 20 mm.
The two balloons (one on each side) should ideally be centered at middle height between the superior and inferior endplates and in the anterior two-thirds of the vertebral body. Balloon placement into the vertebral body is checked using radiopaque markers at the two extremities of the balloon. Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity. Inflation is stopped when one of the following inflation endpoints is reached: pressure raised over 400 psi, balloon contacts one of the cortical bone of the vertebra or reaching maximal balloon inflation volume. The balloons are then deflated and removed. The mean balloon inflation volume is 2 to 3ml. The Bone Filler Device, filled before with 1.5 ml of PMMA, is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula. This step is repeated till a complete fill of the cavity is obtained. The same procedure is repeated through the other working cannula at the contra-lateral pedicle. Filling of the cavity with highly viscous PMMA is performed under continuous fluoroscopic control.
The aim of this study is to quantify the analgesic and patient function improvement of Balloon Kyphoplasty together with complication types and rate in patients with malignant vertebral fractures due to metastatic disease or multiple myeloma.
- Conditions
- Vertebral Fracture, Multiple Myeloma, Osteolytic Metastases
- Being tested
- balloon kyphoplasty
- Keywords
- Vertebral fracture, Vertebral compression fracture, Multiple Myeloma Bone marrow diseases, Vertebral metastases, Balloon Kyphoplasty
- Medical subject headings
- Spinal Fractures, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon kyphoplastyDevice
A bilateral approach is chosen to insert working cannulas into the posterior part of the vertebral body through a posterior transpedicular approach.Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity.The balloons are then deflated and removed. The Bone Filler Device is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | balloon Kyphoplasty Receives: Device: balloon kyphoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients having a residual pain of ≤ 35mm on a VAS scale or a 50 % decrease in daily morphine dose at day 15 after Balloon Kyphoplasty compared to day 0 (day of procedure).
Measured: day 15
Secondary outcomes (12)
1° Clinical Outcomes:· Pain evaluation using a visual analogic scale
Measured: D-8-D-1, D2 to D5, d15, D90, D180; D360
quality of life evaluation (SF 12).
Measured: D-8 to D-1, D2 to D5, D15, D90, D180; D360
Assessment of the pain due to the compression fracture using a VAS scale in the same position as at the inclusion visit (standing or lying down),
Measured: D-8 to D-1, D2 to D5, D15, D90, D180; D360
Assessment of the patient global satisfaction score using a LICKERT Scale,
Measured: D-8 to D-1, D2 to D5, D15, D90, D180; D360
Percentage of patients who estimate than the pain due to the compression has decreased by more than 50% after the procedure,
Measured: day 15
· Percentage of patients who give a positive answer to the following question: "would you agree to undergo a new Balloon Kyphoplasty in case you need it?"
Measured: D2 to D5, D15; D90 ; D180; D360
Time elapsed between Balloon Kyphoplasty procedure and patient get up.
Measured: D2 to D5; D15;D90
Resumption of the upright position for patients confined to bed due to their vertebral fracture
Measured: D2 to D5; D15
Local and general complications related to cement leakage at each vertebral level treated.
Measured: each visit
2° Radiological Outcomes: · Modification of the regional kyphosis angle measured by the Traumatic Regional Angle (ART - STAGNARA and NIEDERMANN) for compression fractures of T10 to L5
Measured: D2to dJ5-d15-d90.-d180- d360
Modification of the global Thoracic and lumbar kyphosis angles.
Measured: D2 to d5 - D15 - D90 - d180 - d360
3° Therapeutic Outcomes :· Need for radiation at day 30 after Balloon Kyphoplasty in patient presenting with Multiple Myeloma.
Measured: D30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionNov 2010
Why it stopped: the data collected are enough to obtain a qualitative analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Denis LAREDO, M.D.,PR., Study director, Assistance Publique - Hôpitaux de ParisAntoine FEYDY, M.D., PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748631
- Sponsor's protocol ID
- P050323
- Acronym
- KYPHOK
- Status last verified
- Nov 2014
- First submitted
- 5 Sep 2008
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Percutaneous Balloon Kyphoplasty in the Treatment of Malignant Vertebral Fractures (Multiple Myeloma and Osteolytic Metastases) : "Observational Study"
- ClinicalTrials.gov ID
- NCT00748631
- Acronym / sponsor ID
- KYPHOK / P050323
- Conditions
- Vertebral Fracture, Multiple Myeloma, Osteolytic Metastases
- Keywords
- Vertebral fracture, Vertebral compression fracture, Multiple Myeloma Bone marrow diseases, Vertebral metastases, Balloon Kyphoplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the data collected are enough to obtain a qualitative analysis.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Sep 2008 (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.
Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications.
This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure.
Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient.
The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.
Detailed description
Vertebral compression fractures (VCF) represent an important source of morbidity in patients presenting osteolytic metastatic or myelomatous vertebral involvement. In addition, cancer treatments may induce osteoporosis with an additional risk of vertebral fractures.
- Current medical treatments are symptomatic. They do not treat the fracture itself.
- Vertebroplasty is an interventional radiological technique that consists of injecting, percutaneously, acrylic cement into the fractured vertebra under radiological guidance and local or general anaesthesia, in order to combine two effects: stabilization of the vertebral body fracture and pain reduction.
- Balloon Kyphoplasty is a variant of vertebroplasty which is performed using the KyphX® System (Medtronic., Sunnyvale, California). Balloon kyphoplasty aims at restore vertebral height of the fractured vertebra using an inflatable balloon prior to inject surgical polymethylmetacrylate (PMMA)cement,into the vertebral body to fix the fracture. It is an expensive technique costing around 4,000 euros for up to 2 vertebrae in the same patient. The surgical technique for the procedure has been described by LIBERMEAN et al: A bilateral approach is usually chosen to insert working cannulas into the posterior part of the vertebral body through a posterior transpedicular approach. In case of limited and asymmetric vertebral destruction, a single unilateral approach may be preferred. Fluoroscopy is used to insert the tools and control the procedure. With reaming tools, two working channels are created and the balloons are inserted. The balloons are available in lengths of 10, 15 and 20 mm.
The two balloons (one on each side) should ideally be centered at middle height between the superior and inferior endplates and in the anterior two-thirds of the vertebral body. Balloon placement into the vertebral body is checked using radiopaque markers at the two extremities of the balloon. Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity. Inflation is stopped when one of the following inflation endpoints is reached: pressure raised over 400 psi, balloon contacts one of the cortical bone of the vertebra or reaching maximal balloon inflation volume. The balloons are then deflated and removed. The mean balloon inflation volume is 2 to 3ml. The Bone Filler Device, filled before with 1.5 ml of PMMA, is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula. This step is repeated till a complete fill of the cavity is obtained. The same procedure is repeated through the other working cannula at the contra-lateral pedicle. Filling of the cavity with highly viscous PMMA is performed under continuous fluoroscopic control.
The aim of this study is to quantify the analgesic and patient function improvement of Balloon Kyphoplasty together with complication types and rate in patients with malignant vertebral fractures due to metastatic disease or multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: balloon kyphoplastyballoon Kyphoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, 18 years or older
- 1 to 3 vertebral compression fracture(s), between T5-L5, responding to the following criteria:
- The pain related to the fractured vertebrae is the more prevalent
- More than 3 months life expectancy.
- Blood Platelets rate more than or equal to 50 000/mm3 within the week before balloon kyphoplasty procedure (after a correct blood transfusion).
Key exclusion criteria (17 listed)
- Patient younger than 18
- Impossibility to perform Balloon Kyphoplasty:
- More than three symptomatic vertebral compression fractures in the same vertebral segment.
- Patient receiving additional local treatment within 15 days after balloon kyphoplasty procedure (surgery, radiofrequency, radiotherapy).
- Patient with primary bone tumors (eg : osteosarcoma) or single solitary plasmocytoma (patients presenting those tumors on other parts of the body, other than VCF are eligible).
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 kyphoplastyA bilateral approach is chosen to insert working cannulas into the posterior part of the vertebral body through a posterior transpedicular approach.Once inserted, the balloons are inflated using visual, volume and pressure control to create a cavity.The balloons are then deflated and removed. The Bone Filler Device is then advanced through the working cannula towards the anterior part of the cavity and cement is slowly extruded by a stainless steel stylet, acting as a plunger. When the amount of cement from the first Bone Filler Device is delivered in the cavity, it is removed and another Bone Filler Device is advanced through the working cannula. | Device | 1 |
Primary outcome
Percentage of patients having a residual pain of ≤ 35mm on a VAS scale or a 50 % decrease in daily morphine dose at day 15 after Balloon Kyphoplasty compared to day 0 (day of procedure).
Time frame: day 15
12 secondary outcomes
1° Clinical Outcomes:· Pain evaluation using a visual analogic scale
Time frame: D-8-D-1, D2 to D5, d15, D90, D180; D360
quality of life evaluation (SF 12).
Time frame: D-8 to D-1, D2 to D5, D15, D90, D180; D360
Assessment of the pain due to the compression fracture using a VAS scale in the same position as at the inclusion visit (standing or lying down),
Time frame: D-8 to D-1, D2 to D5, D15, D90, D180; D360
Assessment of the patient global satisfaction score using a LICKERT Scale,
Time frame: D-8 to D-1, D2 to D5, D15, D90, D180; D360
Percentage of patients who estimate than the pain due to the compression has decreased by more than 50% after the procedure,
Time frame: day 15
· Percentage of patients who give a positive answer to the following question: "would you agree to undergo a new Balloon Kyphoplasty in case you need it?"
Time frame: D2 to D5, D15; D90 ; D180; D360
Time elapsed between Balloon Kyphoplasty procedure and patient get up.
Time frame: D2 to D5; D15;D90
Resumption of the upright position for patients confined to bed due to their vertebral fracture
Time frame: D2 to D5; D15
Local and general complications related to cement leakage at each vertebral level treated.
Time frame: each visit
2° Radiological Outcomes: · Modification of the regional kyphosis angle measured by the Traumatic Regional Angle (ART - STAGNARA and NIEDERMANN) for compression fractures of T10 to L5
Time frame: D2to dJ5-d15-d90.-d180- d360
Modification of the global Thoracic and lumbar kyphosis angles.
Time frame: D2 to d5 - D15 - D90 - d180 - d360
3° Therapeutic Outcomes :· Need for radiation at day 30 after Balloon Kyphoplasty in patient presenting with Multiple Myeloma.
Time frame: D30
Results and safety
The study was stopped early (reason given: the data collected are enough to obtain a qualitative analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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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.
Jean-Denis LAREDO, M.D.,PR. study director
Assistance Publique - Hôpitaux de Paris
Antoine FEYDY, M.D., PhD principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon kyphoplasty in people with Vertebral Fracture and Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
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 10 inclusion and 17 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: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study was stopped early (reason given: the data collected are enough to obtain a qualitative analysis.). Results are not available in the source record.
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?
Percentage of patients having a residual pain of ≤ 35mm on a VAS scale or a 50 % decrease in daily morphine dose at day 15 after Balloon Kyphoplasty compared to day 0 (day of procedure). (time frame: day 15). 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 24 Mar 2015.