CompletedNot Applicable

Clinical Evaluation of the Crosstrees Pod™ 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 range

50 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Six months

Trial details

NCT IDNCT00933036

SponsorCrosstrees Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-06

View on ClinicalTrials.gov More Pathologic Fracture of the Vertebra Due to Osteoporosis trials