Performance and Safety of Joline® Kyphoplasty Single Balloon Catheter Allevo vs. Quattroplasty Double-Balloon Catheter Stop'n GO With BonOs® Inject Bone Cement

- 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.

- 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.

- 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