A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Patient rated pain intensity
Study Overview
Brief Summary
The objective of this study is to gather data regarding the efficacy, safety and cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all vertebroplasties.
The primary effectiveness analysis will be based on the number of patients whose numeric rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly larger proportion of patients achieving pain reduction than the control group. A secondary analysis will compare the change in mean pain scores and specific activity related pain scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary effectiveness analysis will include the mean change in the back-pain specific limitation in function as quantified by the Roland Scale at these same data collection time points.
Detailed Description
The study will be a two arm randomised, blind placebo controlled trial of vertebroplasty for acute (< 6 weeks) osteoporotic vertebral compression fractures. Patients with substantial pain or immobility despite medical therapy will be recruited to the study, randomised to study treatments and followed for 6 months. The primary effectiveness variable is back-pain as recorded on a numerical verbal rating scale at two weeks post-procedure. Secondary effectiveness variable will be the Roland Morris back pain specific disability score.
In parallel with the trial an economic analysis will be conducted.
Study participants will be recruited from patients who are referred for vertebroplasty evaluations from five clinical sites of the Sydney metropolitan area. The sites will be St George Private Hospital, Kareena Private Hospital, St George Public Hospital, Sutherland Hospital and Liverpool Hospital. These sites have the advantage of having robust, established vertebroplasty programs and high levels of technical operator experience with vertebroplasty in acute fractures. Potential patients are patients identified with a recent vertebral fracture that requires assessment for a vertebroplasty. The referring physician will request an MRI and spinal radiograph as part of routine assessment and standard clinical care. Potential involvement in the study will be discussed at this point between patient and referring physician. Patients will be given a consent form to read and consider. The research team will then contact potential subjects and ask them a series of questions to determine eligibility. The investigator and the research coordinator will then describe the study to eligible patients and informed consent will be obtained prior to conducting baseline evaluations and randomization.
Treatment Intervention (Vertebroplasty Procedure):
5.1.1 The procedure is performed under strict aseptic conditions. All personnel wear surgical masks and caps in addition to gowns and gloves for operators, to minimize the risk of infection. 1G ceftriaxone will be administered at the commencement of the procedure unless the patient is allergic. In case of allergy then antibiotics are not mandatory.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patient is greater than 60 years of age.
- •Patient has pain which is not adequately controlled by oral analgesia or which has required hospitalisation and prevents early mobilisation
- •Patient has pain from one or two compression fractures of the vertebrae in the areas T4 to L5 confirmed with a sagittal STIR (short tau inversion recovery) and sagittal T1 weighted MRI scan of the spine. Patients with three or more recent fractures are excluded.
- •Clinical history verifies that patient's fracture occurred in the previous 6 weeks.
- •Patient does not have a known coagulopathy. If on warfarin, the INR should be less than 2.5 within the last three days.
- •Patient has no contraindications for conscious sedation.
- •Patient reports pain during ambulation or movement from the compression fracture(s) of at least seven (7) out of ten (10) on a numerical pain scale.
- •Patient has access to a telephone.
- •Patient speaks English well enough to answer all health questions via telephone.
- •Patient has a confirmed diagnosis of osteoporosis via a BMD within 6 months of baseline or a QCT at baseline.
- •Patient does not have a history of debilitating chronic back pain which requires regular analgesia.
- •Patients with chronic back pain who regularly use medication containing any narcotic for a period greater than 6 weeks, that is prior to the acute fracture.
- •Patient does not have significant retropulsed fragment or spinal canal compromise of greater than 20% by retropulsed fragment.
- •Patient has no mental incapacity or dementia that makes him/her unable to give informed consent.
- •Patient has no history of vertebral osteomyelitis.
- •Patient has vertebral body collapse not greater than 60% relative to closest intact vertebra.
- •Patient has no pedicle fractures.
- •Patient has no active local or systemic infection.
- •Patient has not had surgery (within the last 60 days).
- •Patient has no concomitant hip fracture.
- •Patient has no malignant tumour deposit (multiple myeloma), tumour mass, or tumour extension into the epidural space at the level of the fracture to be treated on MRI.
- •Patient does not have severely immunocompromised health status (including any patient who is HIV positive, currently on chemotherapy, taking high doses of long term corticosteroids - defined as a dose of prednisone exceeding 10mg for greater than 3 months in the last 12 months, has a hematologic malignancy, or a transplant recipient.)
- •Patient able to attend face to face visits.
Outcomes
Primary Outcomes
Patient rated pain intensity
Time Frame: two weeks
Secondary Outcomes
- Functional Disability(two weeks)
Investigators
Paul Bird
Principal Investigator
Optimus Clinical Research