Vertebral Compression FractureNCT04581707
Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOs® Inject Bone Cement
An observational study of Vertebral Compression Fracture, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone cement for treatment of Vertebral Compression Fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Compression Fracture
- What is being tested?
- Kyphoplasty Single Balloon Catheter Allevo and Quattroplasty Double Balloon Catheter Stop'n GO
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to Oct 2021
- Phase
- Observational
- 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
Study population: Patients undergoing or patients who have already undergone percutaneous balloon kyphoplasty for treatment of Vertebral Compression Fractures as indicated in the Instructions for use of the investigational devices.
Who may be able to join
- patients aged ≥18 years
- 1-3 painful VCF(s), of which at least 1 meets the following criteria:
- VCF between T7 and L5
- Fracture age <3 months
- VCF shows hyperintense signal on STIR or T2 sequence MRI.
- Investigator estimates that target VB(s) is/ are suitable for Quattroplasty double balloon catheter or Kyphoplasty single balloon catheter (e.g. appropriate pedicle diameter, no cortical bone protruding into the spinal canal).
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- Patient has an ODI score of 30% or more.
- Patient is willing and able to comply with study requirements.
- Patient signs informed consent form.
- Women who are post-menopausal, surgically sterile or on contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.
Who cannot join
- Segmental kyphosis of target VB of >30°
- Pre-existing or clinically unstable neurologic deficit
- Any physical exam evidence of myelopathy or radiculopathy
- Not able to walk without assistance prior to fractures
- Any radiographic evidence of pedicle fracture or interspinous-process widening
- Spondylolisthesis >grade 1 at target VB(s)
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- History of spine surgery, including prior vertebral augmentation, during the last year
- Any underlying systemic bone disease other than osteoporosis (e.g. osteomalacia, osteogenesis imperfect, etc.)
- Irreversible coagulopathy and/or taking peri-operatively warfarin (Coumadin) or other anticoagulant
- Pregnancy and nursing
- Pain due to any other condition that requires daily narcotic medication
- Disabling back pain due to causes other than acute fracture
- History of intolerance, or allergic reaction to titanium or acrylic compounds
- Active systemic or local infection at baseline
- Severe cardiopulmonary disease (e.g. stage IV heart failure, severe chronic obstructive pulmonary disease)
- Any other medical illness or condition that, in the investigator's opinion, is likely to impair long-term follow-up (e.g. cancer) or greatly increase the risk of surgery
- Any evidence of substance abuse
- The patient is on long-term steroid therapy (steroid dose 30 mg/day for >3 months)
- The patient is known to be involved in medical litigation including Workmen's compensation.
- Patient with contraindication for MRI including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
- Patient who is contraindicated for the use of PMMA cement
- Patients who belong to a vulnerable population or that are not able to sign the informed consent form.
- Patients where the VCF was treated in combination with fusion.
- Patients with any contraindication according to the IFU
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital for Orthopedics Tuebingen
Tübingen, 72076
Lisanne Exner
Lisanne Exner
About this study
Official title: Evaluation of Surgical Therapy of Vertebral Compression Fractures With the Kyphoplasty Single Balloon Catheter Allevo (Joline®) and the Quattroplasty Double Balloon Catheter Stop'n GO (Joline®) With BonOs® Inject Bone Cement
The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone cement for treatment of Vertebral Compression Fractures.
Read the detailed description
Vertebral compression fracture (VCF) is a very common medical problem and describes the collapse of a vertebral body (VB) in the spine. VCF can lead to severe pain, decreased physical function, spinal deformity and in rare cases thoracic or abdominal wall deformities, that can impair pulmonary and gastrointestinal function. A VCF can occur in patients with healthy spines upon severe trauma, in patients suffering from osteoporosis or in patients with metastatic tumors.
Currently available therapy for VCF includes medical management, surgical treatments and vertebral augmentation (VA). Medical management consists of bed rest followed by early mobilization and analgesic medications. Surgical options include spinal stabilization with rods and screws. VA procedures attempt to stabilize the spine and reduce vertical compression by adding material to the spine.
Kyphoplasty is a commonly performed VA procedure. In kyphoplasty, a surgical instrument is used to reduce the collapsed VB towards its original shape. Reduction of the fractured VB is thought to be beneficial since (1) it may reduce anterior directed compressive forces resulting from kyphosis of the spine due to the fracture, and (2) it may reduce some physiologic abnormalities due to kyphosis, such as restrictive lung disease or abdominal compression. After fracture reduction, bone cement is placed in the VB to stabilize the reduction. Fracture reduction follows the orthopedic general principles of fracture repair: reduction and stabilization.
Primary objective of this observational study is to compare the effectiveness of the Quattroplasty double balloon catheter Stop'n GO (Joline®) with the Kyphoplasty single balloon catheter Allevo (Joline®) combined with BonOs® Inject bone cement for use in VCF reduction, to confirm the performance of those two devices and to investigate potential major adverse events associated with the use of the device in patients treated in a controlled setting when used according to the IFU. Secondary objective is to compare the safety of the Quattroplasty double balloon catheter Stop'n GO (Joline®) with the Kyphoplasty single balloon catheter Allevo (Joline®) combined with BonOs® Inject bone cement.
- Conditions
- Vertebral Compression Fracture
- Being tested
- Kyphoplasty Single Balloon Catheter Allevo, Quattroplasty Double Balloon Catheter Stop'n GO
- Keywords
- Vertebral augmentation, Balloon kyphoplasty systems, Bone cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyphoplasty Single Balloon Catheter AllevoDevice
Vertebral compression fractures treated with Kyphoplasty Single Balloon Catheter Allevo (Joline®) and BonOs® Inject bone cement
Quattroplasty Double Balloon Catheter Stop'n GODevice
Vertebral compression fractures treated with Stop'n GO double balloon kyphoplasty system (Joline®) and BonOs® Inject bone cement
| Study group | Role | What they receive |
|---|---|---|
| Kyphoplasty Single Balloon Catheter Allevo | Not described Receives: Device: Kyphoplasty Single Balloon Catheter Allevo | |
| Quattroplasty Double Balloon Catheter Stop'n GO | Not described Receives: Device: Quattroplasty Double Balloon Catheter Stop'n GO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vertebral body height
Change in vertebral body height
Measured: pre-operative, 5 days and 3 months post-operatively
Change in Visual Analog Scale (VAS) of subjective pain
The Visual Analog Scale (VAS) is a measure for pain intensity. The score of the sclae ranges from 0 for "no pain" to 10 for "worst imaginable pain". Patients will report their pain at baseline and at 2 dedicated periods to assess change in pain intensity.
Measured: pre-operation, 5 days and 3 months post-operation
Change in functional disability
The Oswestry Disability Index (ODI) is used to assess functional disability. The questionnaire consists of 10 items with each item having 6 statements. All scores are summed, then multiplied by two to obtain the index (range from 0 to 100) with higher score indicating greater disability.
Measured: pre-operation, 5 days and 3 months post-operation
Secondary outcomes (1)
Safety Outcomes: Occurence of adverse events and complications
Occurence of adverse events and complications
Measured: during procedure, 5 days and 3 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Mar 2020
- Primary completionJun 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Compression FractureStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisanne Exner, University Hospital Tuebingen
- Investigators
- Lisanne Exner, Principal investigator, University Hopsital for Orthopedics Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581707
- Sponsor's protocol ID
- JO-2020Kypho
- Status last verified
- Jan 2021
- First submitted
- 18 Sep 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Therapy of Vertebral Compression Fractures With the Kyphoplasty Single Balloon Catheter Allevo (Joline®) and the Quattroplasty Double Balloon Catheter Stop'n GO (Joline®) With BonOs® Inject Bone Cement
- ClinicalTrials.gov ID
- NCT04581707
- Acronym / sponsor ID
- JO-2020Kypho
- Conditions
- Vertebral Compression Fracture
- Keywords
- Vertebral augmentation, Balloon kyphoplasty systems, Bone cement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 9 Oct 2020 (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.
The purpose of this study is to assess the performance and safety of two balloon kyphoplasty systems (Joline®), the single balloon catheter Allevo and Quattroplasty double balloon catheter Stop'n Go, using BonOs® Inject bone cement for treatment of Vertebral Compression Fractures.
Detailed description
Vertebral compression fracture (VCF) is a very common medical problem and describes the collapse of a vertebral body (VB) in the spine. VCF can lead to severe pain, decreased physical function, spinal deformity and in rare cases thoracic or abdominal wall deformities, that can impair pulmonary and gastrointestinal function. A VCF can occur in patients with healthy spines upon severe trauma, in patients suffering from osteoporosis or in patients with metastatic tumors.
Currently available therapy for VCF includes medical management, surgical treatments and vertebral augmentation (VA). Medical management consists of bed rest followed by early mobilization and analgesic medications. Surgical options include spinal stabilization with rods and screws. VA procedures attempt to stabilize the spine and reduce vertical compression by adding material to the spine.
Kyphoplasty is a commonly performed VA procedure. In kyphoplasty, a surgical instrument is used to reduce the collapsed VB towards its original shape. Reduction of the fractured VB is thought to be beneficial since (1) it may reduce anterior directed compressive forces resulting from kyphosis of the spine due to the fracture, and (2) it may reduce some physiologic abnormalities due to kyphosis, such as restrictive lung disease or abdominal compression. After fracture reduction, bone cement is placed in the VB to stabilize the reduction. Fracture reduction follows the orthopedic general principles of fracture repair: reduction and stabilization.
Primary objective of this observational study is to compare the effectiveness of the Quattroplasty double balloon catheter Stop'n GO (Joline®) with the Kyphoplasty single balloon catheter Allevo (Joline®) combined with BonOs® Inject bone cement for use in VCF reduction, to confirm the performance of those two devices and to investigate potential major adverse events associated with the use of the device in patients treated in a controlled setting when used according to the IFU. Secondary objective is to compare the safety of the Quattroplasty double balloon catheter Stop'n GO (Joline®) with the Kyphoplasty single balloon catheter Allevo (Joline®) combined with BonOs® Inject bone cement.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kyphoplasty Single Balloon Catheter Allevo | – | Device: Kyphoplasty Single Balloon Catheter Allevo |
| Quattroplasty Double Balloon Catheter Stop'n GO | – | Device: Quattroplasty Double Balloon Catheter Stop'n GO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing or patients who have already undergone percutaneous balloon kyphoplasty for treatment of Vertebral Compression Fractures as indicated in the Instructions for use of the investigational devices.
Key inclusion criteria (10 listed)
- patients aged ≥18 years
- 1-3 painful VCF(s), of which at least 1 meets the following criteria:
- Investigator estimates that target VB(s) is/ are suitable for Quattroplasty double balloon catheter or Kyphoplasty single balloon catheter (e.g. appropriate pedicle diameter, no cortical bone protruding into the spinal canal).
- Patient has an ODI score of 30% or more.
- Patient is willing and able to comply with study requirements.
Key exclusion criteria (24 listed)
- Segmental kyphosis of target VB of >30°
- Pre-existing or clinically unstable neurologic deficit
- Any physical exam evidence of myelopathy or radiculopathy
- Not able to walk without assistance prior to fractures
- Any radiographic evidence of pedicle fracture or interspinous-process widening
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 |
|---|---|---|
| Kyphoplasty Single Balloon Catheter AllevoVertebral compression fractures treated with Kyphoplasty Single Balloon Catheter Allevo (Joline®) and BonOs® Inject bone cement | Device | Kyphoplasty Single Balloon Catheter Allevo |
| Quattroplasty Double Balloon Catheter Stop'n GOVertebral compression fractures treated with Stop'n GO double balloon kyphoplasty system (Joline®) and BonOs® Inject bone cement | Device | Quattroplasty Double Balloon Catheter Stop'n GO |
Primary outcome
Change in vertebral body height
Time frame: pre-operative, 5 days and 3 months post-operatively
Change in vertebral body height
Change in Visual Analog Scale (VAS) of subjective pain
Time frame: pre-operation, 5 days and 3 months post-operation
The Visual Analog Scale (VAS) is a measure for pain intensity. The score of the sclae ranges from 0 for "no pain" to 10 for "worst imaginable pain". Patients will report their pain at baseline and at 2 dedicated periods to assess change in pain intensity.
Change in functional disability
Time frame: pre-operation, 5 days and 3 months post-operation
The Oswestry Disability Index (ODI) is used to assess functional disability. The questionnaire consists of 10 items with each item having 6 statements. All scores are summed, then multiplied by two to obtain the index (range from 0 to 100) with higher score indicating greater disability.
1 secondary outcome
Safety Outcomes: Occurence of adverse events and complications
Time frame: during procedure, 5 days and 3 months post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- 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.
Lisanne Exner principal investigator
University Hopsital for Orthopedics Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Compression Fracture, run by University Hospital Tuebingen at 1 site in Germany.
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 24 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 19 Jan 2021. 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 Germany. 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 Lisanne Exner (+4970712986646, Lisanne.Exner@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vertebral body height (time frame: pre-operative, 5 days and 3 months post-operatively). 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?
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 19 Jan 2021.