Vertebral Compression Fracture Clinical Trial
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
NCT number | NCT04581707 |
Other study ID # | JO-2020Kypho |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | October 2021 |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | October 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). - 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. Exclusion Criteria: - 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) - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital for Orthopedics Tuebingen | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in vertebral body height | Change in vertebral body height | pre-operative, 5 days and 3 months post-operatively | |
Primary | 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. | pre-operation, 5 days and 3 months post-operation | |
Primary | 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. | pre-operation, 5 days and 3 months post-operation | |
Secondary | Safety Outcomes: Occurence of adverse events and complications | Occurence of adverse events and complications | during procedure, 5 days and 3 months post-operation |
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