Vertebroplasty, a procedure where spine surgeons use image guidance to inject bone cement through a needle into the fractured area of the bone, has shown good results for several years and validated by numerous clinical studies worldwide, says David Veino, national director of sales and marketing for Stryker Interventional Spine. However, a recent study published in the New England Journal of Medicine found that vertebroplasty has no beneficial effects over a "sham" procedure, in which an anesthetic was injected over the target pedicle of the effected vertebrae instead of the cement. Mr. Veino says “physicians should examine the study's shortcomings and continue recommending vertebroplasty to the appropriate patients.”
The case for vertebroplasty
Mr. Veino says 90 percent of vertebroplasty patients report being pain-free after the procedure. Furthermore, a study recently published in The Lancet (Vertos II) found that vertebroplasty was effective in eliminating the patient's pain.
Vertebroplasty is an outpatient procedure and does not require bed rest afterwards. Patients return to their normal activity quicker than if they had received traditional spine surgery and they require less pain medication after the procedure. When patients are able to return to their daily lives quicker, they are more economically productive and have higher rates of satisfaction.
New England Journal of Medicine study response
The study in the New England Journal of Medicine conducted research on back pain patients who either underwent vertebroplasty or a simulated procedure where the patients were not injected with cement. Patients were not aware of which procedure they received. During a one-month follow-up, the researchers found no significant difference in pain between the two groups.
"The studies were good in terms of the clinical community moving forward to further demonstrate the efficacy of the procedure, however there are significant flaws with the studies," says Mr. Veino. The study did not examine the length of time that the patient had the vertebral compression fracture before treatment nor did the researchers distinguish between acute and sub acute osteoporotic vertebral compression fractures the patients had.
The study reviewed 78 patients resulting in a high cross over rate of patients from the sham group, which Mr. Veino says is too few patients to record statistically significant data. The patients were not diagnosed with MRI, which means the researchers couldn’t confirm whether the patients had compression fractures that needed treatment or were healing on their own. The "sham" procedure was not how patients are usually treated, which means the study did not mimic real-world treatment.
Since the study was published, the American Academy of Orthopedic Surgeons board of directors approved and released a clinical practice guideline recommending against vertebroplasty, which could have an impact on whether orthopedic and primary care physicians choose to recommend the procedure.
"We've got to get away from using clinical studies without real-world circumstances to decide whether we believe in a procedure," says Mr. Veino.
The Lancet study response
Researchers conducting the "Vertos II" study examined more than 208 patients who had vertebral compression fractures who were randomly allocated to vertebroplasty or conservative treatment. Researchers found that vertebroplasty has the potential to enhance patient outcomes and improve cost efficiency if used appropriately.
"This study was very sound in its design and statistical significance," says Mr. Veino. "These real world studies are exactly what physicians need to see."
All patients were found to have osteoporotic vertebral compression fractures on radiographic images taken before treatment and confirmed by an MRI, which Mr. Veino says are important aspects of reducing the variables in this study. Patients who received vertebroplasty during the early stages of their treatment reported higher pain relief and better overall treatment outcomes.
"Physicians need to see real-world, rigorous studies so they can really understand the procedures and decide which type of care their patients need," says Mr. Veino. If physicians do not have the right information about the effectiveness of procedures, he says, they may wait longer to refer patients for that treatment, thus keeping the patient in pain longer and worsening the problem.
Read the study published in The New England Journal of Medicine.
Read the study published in The Lancet.
Learn more about Stryker.
Read other coverage on vertebroplasty:
- AAOS: Vertebroplasty Ineffective in Treating Spinal Fractures
- NASS: Review and Consider New Literature on Vertebroplasty
- RF Kyphoplasty Shows Less Cement Leakage Than Vertebroplasty
The case for vertebroplasty
Mr. Veino says 90 percent of vertebroplasty patients report being pain-free after the procedure. Furthermore, a study recently published in The Lancet (Vertos II) found that vertebroplasty was effective in eliminating the patient's pain.
Vertebroplasty is an outpatient procedure and does not require bed rest afterwards. Patients return to their normal activity quicker than if they had received traditional spine surgery and they require less pain medication after the procedure. When patients are able to return to their daily lives quicker, they are more economically productive and have higher rates of satisfaction.
New England Journal of Medicine study response
The study in the New England Journal of Medicine conducted research on back pain patients who either underwent vertebroplasty or a simulated procedure where the patients were not injected with cement. Patients were not aware of which procedure they received. During a one-month follow-up, the researchers found no significant difference in pain between the two groups.
"The studies were good in terms of the clinical community moving forward to further demonstrate the efficacy of the procedure, however there are significant flaws with the studies," says Mr. Veino. The study did not examine the length of time that the patient had the vertebral compression fracture before treatment nor did the researchers distinguish between acute and sub acute osteoporotic vertebral compression fractures the patients had.
The study reviewed 78 patients resulting in a high cross over rate of patients from the sham group, which Mr. Veino says is too few patients to record statistically significant data. The patients were not diagnosed with MRI, which means the researchers couldn’t confirm whether the patients had compression fractures that needed treatment or were healing on their own. The "sham" procedure was not how patients are usually treated, which means the study did not mimic real-world treatment.
Since the study was published, the American Academy of Orthopedic Surgeons board of directors approved and released a clinical practice guideline recommending against vertebroplasty, which could have an impact on whether orthopedic and primary care physicians choose to recommend the procedure.
"We've got to get away from using clinical studies without real-world circumstances to decide whether we believe in a procedure," says Mr. Veino.
The Lancet study response
Researchers conducting the "Vertos II" study examined more than 208 patients who had vertebral compression fractures who were randomly allocated to vertebroplasty or conservative treatment. Researchers found that vertebroplasty has the potential to enhance patient outcomes and improve cost efficiency if used appropriately.
"This study was very sound in its design and statistical significance," says Mr. Veino. "These real world studies are exactly what physicians need to see."
All patients were found to have osteoporotic vertebral compression fractures on radiographic images taken before treatment and confirmed by an MRI, which Mr. Veino says are important aspects of reducing the variables in this study. Patients who received vertebroplasty during the early stages of their treatment reported higher pain relief and better overall treatment outcomes.
"Physicians need to see real-world, rigorous studies so they can really understand the procedures and decide which type of care their patients need," says Mr. Veino. If physicians do not have the right information about the effectiveness of procedures, he says, they may wait longer to refer patients for that treatment, thus keeping the patient in pain longer and worsening the problem.
Read the study published in The New England Journal of Medicine.
Read the study published in The Lancet.
Learn more about Stryker.
Read other coverage on vertebroplasty:
- AAOS: Vertebroplasty Ineffective in Treating Spinal Fractures
- NASS: Review and Consider New Literature on Vertebroplasty
- RF Kyphoplasty Shows Less Cement Leakage Than Vertebroplasty