Surgery for Your Lumbar Spinal Stenosis Patients? Maybe Not
Surgery for Your Lumbar Spinal Stenosis Patients? Maybe Not
The incidence of lumbar spinal stenosis (LSS) is estimated at 8%-11% of the population of the United States, with some 2.4 million Americans expected to be affected by 2021. Many of these patients experience or will experience considerable pain.
The great question for orthopedic spine surgeons is whether to recommend surgery. For patients, it is whether surgery is worth the risk.
The largest randomized study to date to compare the outcomes of LSS surgery with those of nonsurgical treatment—the Spine Patient Outcomes Research Trial (SPORT)—has offered some context for the answer, although the decision will still be individualized to the patient. It found a distinct advantage for surgical treatment 4 years after surgery. But 4 years after that, the benefits between surgical and nonsurgical treatment were not significantly different.
However, lead author Jon Lurie, MD, associate professor of orthopaedic surgery at the Geisel School of Medicine at the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, New Hampshire, noted that the 8-year results don't diminish the benefit that patients experienced in the first 4 years following surgery.
"What this shows is that surgery for spinal stenosis has an advantage in the short term, but those results decay with time—which is not generally too surprising when you're talking about a degenerative disease," Dr Lurie told Medscape. "The benefit of surgery seems to go away in the fifth and sixth years after treatment, until by year 8, when the two groups in the randomized portion of the trial are nearly indistinguishable."
"It's worth noting that this group started at a mean age of 65, and we're looking at them 8 years later," Dr Lurie added. "Function deteriorates somewhat between 65 and 73 years of age, whether patients have spinal stenosis or not. A lot of things are happening. People who can't walk know they can't walk. How much is due to stenosis? How much to other causes? They have a great deal of trouble sorting that out. They just know how they're doing."
The SPORT study, which involved 13 medical centers in 11 states, included image-confirmed LSS patients who were symptomatic for 12 weeks or longer. Patients who did not wish to be randomly assigned made up an observational cohort of 365 individuals, 219 of whom initially chose surgery and 146 of whom initially chose nonoperative care. The randomized cohort included 289 patients; 138 patients were randomly assigned to surgical treatment and 151 to nonoperative treatment.
The surgery was standard posterior decompressive laminectomy. The protocol surgery for degenerative spondylolisthesis included the possibility of bilateral single-level fusion (autogenous iliac crest bone grafting with or without posterior pedicle screw instrumentation). The nonoperative protocol was "usual care" (active physical therapy, education/counseling with home exercise instruction, and nonsteroidal anti-inflammatory drugs if patients would tolerate them). Additional treatment options (epidural steroids, analgesics, spinal manipulation) were available.
"There certainly was not very good evidence for one particular nonoperative intervention in spinal stenosis 15 years ago, and today there still isn't," Dr Lurie said. "So people were randomized to the best individualized nonoperative treatment by physicians who specialize in spine care at these centers."
Primary endpoints for the trial were scores on the Medical Outcomes Study 36-Item Short-Form Health Survey Bodily Pain and Physical Function scales, a 0-100 scale in which a high score indicates less severe symptoms; and the AAOSMODEMS version of the Oswestry Disability Index, a 0-100 scale in which a lower score indicates less severe symptoms. Secondary endpoints were patient-reported improvement; satisfaction with current symptoms and care; the Stenosis Bothersomeness Index, a 0-24 scale in which a lower score indicates less severe symptoms; and the Low Back Pain Bothersomeness Scale, a 0-6 scale in which a low score indicates less severe symptoms.
Plans for an intention-to-treat analysis fell through due to the large percentage of patients (52%) who had surgery despite being randomly assigned to nonoperative care. Instead, researchers conducted as-treated analyses, one for the observational group and one for the randomized group. Surgical patients in the as-treated randomized group fared better than nonsurgical patients in the first 4 years post-surgery, but by 5 years the benefit of surgery had diminished.
There were fewer crossovers in the observational cohort, with 25% of patients who began in the nonoperative-care group opting for surgery within 3 years of joining the study. While the randomized group showed that the early benefit of surgery out to 4 years converged over time, with no significant treatment effect of surgery seen in years 6-8 for any of the primary outcomes, the observational group showed a stable advantage for surgery in all outcomes between years 5 and 8.
Nearly half of the original participants were lost to follow-up. Patients lost to follow-up were, on average, older, sicker, less well educated, and had worse outcomes at 2 years in both the observational arm and the randomized arm, the investigators found. That may have led to an overly positive assessment of treatment effect at 8 years in both the randomized and observational groups.
"I think SPORT accomplished quite a lot," Dr Lurie said. "I don't think that the SPORT study found a new idea no one ever thought of before, or turned what people thought was happening on its head, because it didn't. But it added much more precision to our understanding of what the outcomes of these treatments are. In the context of shared decision-making, having precise, reliable, valid information is incredibly important."
Surgical vs Nonsurgical Treatment for Lumbar Spinal Stenosis
The incidence of lumbar spinal stenosis (LSS) is estimated at 8%-11% of the population of the United States, with some 2.4 million Americans expected to be affected by 2021. Many of these patients experience or will experience considerable pain.
The great question for orthopedic spine surgeons is whether to recommend surgery. For patients, it is whether surgery is worth the risk.
The largest randomized study to date to compare the outcomes of LSS surgery with those of nonsurgical treatment—the Spine Patient Outcomes Research Trial (SPORT)—has offered some context for the answer, although the decision will still be individualized to the patient. It found a distinct advantage for surgical treatment 4 years after surgery. But 4 years after that, the benefits between surgical and nonsurgical treatment were not significantly different.
However, lead author Jon Lurie, MD, associate professor of orthopaedic surgery at the Geisel School of Medicine at the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, New Hampshire, noted that the 8-year results don't diminish the benefit that patients experienced in the first 4 years following surgery.
"What this shows is that surgery for spinal stenosis has an advantage in the short term, but those results decay with time—which is not generally too surprising when you're talking about a degenerative disease," Dr Lurie told Medscape. "The benefit of surgery seems to go away in the fifth and sixth years after treatment, until by year 8, when the two groups in the randomized portion of the trial are nearly indistinguishable."
"It's worth noting that this group started at a mean age of 65, and we're looking at them 8 years later," Dr Lurie added. "Function deteriorates somewhat between 65 and 73 years of age, whether patients have spinal stenosis or not. A lot of things are happening. People who can't walk know they can't walk. How much is due to stenosis? How much to other causes? They have a great deal of trouble sorting that out. They just know how they're doing."
The Largest Randomized Trial to Date
The SPORT study, which involved 13 medical centers in 11 states, included image-confirmed LSS patients who were symptomatic for 12 weeks or longer. Patients who did not wish to be randomly assigned made up an observational cohort of 365 individuals, 219 of whom initially chose surgery and 146 of whom initially chose nonoperative care. The randomized cohort included 289 patients; 138 patients were randomly assigned to surgical treatment and 151 to nonoperative treatment.
The surgery was standard posterior decompressive laminectomy. The protocol surgery for degenerative spondylolisthesis included the possibility of bilateral single-level fusion (autogenous iliac crest bone grafting with or without posterior pedicle screw instrumentation). The nonoperative protocol was "usual care" (active physical therapy, education/counseling with home exercise instruction, and nonsteroidal anti-inflammatory drugs if patients would tolerate them). Additional treatment options (epidural steroids, analgesics, spinal manipulation) were available.
"There certainly was not very good evidence for one particular nonoperative intervention in spinal stenosis 15 years ago, and today there still isn't," Dr Lurie said. "So people were randomized to the best individualized nonoperative treatment by physicians who specialize in spine care at these centers."
Primary endpoints for the trial were scores on the Medical Outcomes Study 36-Item Short-Form Health Survey Bodily Pain and Physical Function scales, a 0-100 scale in which a high score indicates less severe symptoms; and the AAOSMODEMS version of the Oswestry Disability Index, a 0-100 scale in which a lower score indicates less severe symptoms. Secondary endpoints were patient-reported improvement; satisfaction with current symptoms and care; the Stenosis Bothersomeness Index, a 0-24 scale in which a lower score indicates less severe symptoms; and the Low Back Pain Bothersomeness Scale, a 0-6 scale in which a low score indicates less severe symptoms.
Plans for an intention-to-treat analysis fell through due to the large percentage of patients (52%) who had surgery despite being randomly assigned to nonoperative care. Instead, researchers conducted as-treated analyses, one for the observational group and one for the randomized group. Surgical patients in the as-treated randomized group fared better than nonsurgical patients in the first 4 years post-surgery, but by 5 years the benefit of surgery had diminished.
There were fewer crossovers in the observational cohort, with 25% of patients who began in the nonoperative-care group opting for surgery within 3 years of joining the study. While the randomized group showed that the early benefit of surgery out to 4 years converged over time, with no significant treatment effect of surgery seen in years 6-8 for any of the primary outcomes, the observational group showed a stable advantage for surgery in all outcomes between years 5 and 8.
Nearly half of the original participants were lost to follow-up. Patients lost to follow-up were, on average, older, sicker, less well educated, and had worse outcomes at 2 years in both the observational arm and the randomized arm, the investigators found. That may have led to an overly positive assessment of treatment effect at 8 years in both the randomized and observational groups.
"I think SPORT accomplished quite a lot," Dr Lurie said. "I don't think that the SPORT study found a new idea no one ever thought of before, or turned what people thought was happening on its head, because it didn't. But it added much more precision to our understanding of what the outcomes of these treatments are. In the context of shared decision-making, having precise, reliable, valid information is incredibly important."
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