Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebr… (NCT00933036) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of the Crosstrees Podâ„¢ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients
United States135 participantsStarted 2009-06
Plain-language summary
The clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient is at least 50 years old.
✓. Patient must have a fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1 fractures (all) may be included in the study).
✓. Patient must have confirmed acute pain and tenderness over the spine at or near the level of x-ray compression deformity OR positive MRI evaluation.
✓. Patient must NOT have more than (3) three vertebral compression fractures located between T4 and L5.
✓. Subjects affected vertebral body must have a loss of 0- 50% in vertebral height as compared with the height of an adjacent normal vertebral body confirmed by radiological evaluation.
✓. Subject fracture is confirmed by MRI imaging including T1, T2 and STIR-weighted studies to determine the type and presence of fracture(s).
✓. Subjects affected vertebral body height and geometry is adequate for insertion of access instruments of 5.2mm OD, as determined by the investigator.
✓. Subjects pain score is equal to or greater than 5 according to the visual analog scale (VAS).
Exclusion criteria
✕. Patient has significant vertebral collapse, defined as \> 50% of the original height of the vertebral body, as measured against the nearest normal vertebral body. Degree of collapse will be determined by using the height of the nearest normal vertebral body to represent 100% and dividing the height of the collapsed vertebral body by the height of the normal vertebral body.
What they're measuring
1
Clinically significant improvement in pain as measured using a 10 mm Visual Analog Scale (VAS). In this scale 0 means "no pain" and 10 is "Severe pain". A difference of at least 2 points compared to baseline is regarded as clinically relevant.
✕. Patient has painful VCF with fracture age greater than 6 months.
✕. Patients has primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
✕. Patient has a fracture that extends into the posterior vertebral body wall.
✕. Patient has neurological compromise (including myelopathy) and instability
✕. Patient has a retropulsion severe enough to cause myelopathy, unless prior surgical decompression is performed.