Outcomes following 10-Year mark of Spine Patient Outcomes
Research Trial for Intervertebral Disc Herniation
A Path Through History
- Goldthwait and Osgood identified disc protrusion as the cause of lower extremity paresis in 1911.
- In 1929, two patients with complaints of back and leg pain were surgically treated by Dandy, an American neurosurgeon.
- In 1932, Barr, an orthopedic surgeon, and Mixter, a neurosurgeon, reported the first intentional discectomy for treating disc herniation. During this time, the use of surgical discectomy increased rapidly, which led to questioning of the effectiveness of surgical treatment.
- During the 1980s, Weber and Hakelius demonstrated that nonoperative treatment could lead to significant improvement in many patients, and the debate over surgical versus nonoperative interventions began as a result.
- The establishment of the Spine Patient Outcomes Research Trial (SPORT) was driven by the need for a comprehensive study with prospectively collected data.
SPORT yielded evidence regarding the suitability of spinal surgery in patients and also provided data for comparing surgical treatment with nonoperative treatment. SPORT’s data has shed light on the appropriate role of surgical intervention in managing intervertebral disc herniation (IDH), degenerative spondylolisthesis (DS), and lumbar spinal stenosis (SpS).
According to the literature, the OBS cohort analysis for intervertebral disc herniation (IDH) demonstrates a statistically significant greater improvement in all primary outcomes at 3 months and 2 years in patients who underwent surgery compared to those who received nonoperative treatment.
However, the analysis of the RTC cohort failed to show a significant difference based on the intent-to-treat principle due to significant patient crossover. Nonetheless, the as-treated analysis at 4 and 8 years revealed statistically significant greater improvements in patients who received surgical treatment compared to those who received nonoperative treatment.
Surgical treatment results in a significantly greater improvement in patients compared to nonoperative treatment. A greater treatment effect (TE) is associated with being married, experiencing a deteriorating symptom trend at baseline, the absence of joint problems, older age, no worker’s compensation, longer symptom duration, high school education or less, and an SF-36 mental component score less than 35.
Patients without joint problems or diabetes, those who were married, and those who experienced worsening symptoms at baseline demonstrated a greater improvement with surgical intervention. Surgical intervention yields significantly better outcomes for other groups of patients as well.
For instance, patients who have sequestered fragments visible on Magnetic Resonance Imaging (MRI), patients who present with higher levels of baseline back pain and radiculopathy, those with symptoms that have persisted for a longer period of time, and those who were not employed or disabled at the start of the study.
Although obese patients may not experience the same degree of benefit from surgical or non-surgical treatment as non-obese patients, both of them can still experience significant improvements in outcomes with surgical treatment.
Moreover, there are no significant differences in complications such as intraoperative dural tear, spinal fluid leak, nerve root injury, postoperative nerve root injury, wound hematoma, and wound infection between obese and non-obese patients. Surgery duration and hospital stay are slightly extended.
Patients with upper lumbar herniations had significantly greater treatment effect from surgical treatment than patients with L5-S1 herniations for the BP, PF subscales, and ODI at 2 years. When comparing the treatment effect (TE) of surgery between L4-L5 and L5-S, the difference is only significant for the PF subscale.
The treatment effect is the smallest at the L5-S1 level, with intermediate effects at L4-L5, and the largest effects at the L2-L3 and L3-L4 levels, as observed in the data. The variation in improvement between different levels is attributed to the fact that patients with upper lumbar herniations have less improvement after nonoperative treatment.
Symptoms and Pain
Patients who experience symptoms for a duration of six months or more prior to treatment exhibit significantly worse primary outcomes, irrespective of the type of treatment received, whether surgical or nonoperative.
To anticipate possible outcomes, it is necessary to assess several factors, including the recurrence of symptoms, time taken for initial symptom resolution, sociodemographics, clinical characteristics, work-related factors, herniation characteristics detected through imaging, and the level of pain at baseline.
Patients who have L5-S1 IDH on MRI and undergo L5-S1 discectomy have shown that those with retrolisthesis have significantly worse BP and PF outcomes over a 4-year period, but no significant differences were found in ODI or SBI.
Furthermore, retrolisthesis does not have a significant impact on factors such as operative time, blood loss, length of hospital stay, incidence of complications, the likelihood of additional spine surgeries, or recurrence of intervertebral disc herniation. Patients with retrolisthesis have worse postoperative outcomes.
Previous Treatments’ Effects
In terms of patient preferences, surgery was preferred by patients who did not receive an injection. Patients do not experience any improvement in their outcomes in the short or long term. Patients who underwent injections were more likely to switch to non-surgical treatment, but this may be due to their greater reluctance to undergo surgery.
Opioid users demonstrate significantly worse baseline scores in both primary and secondary outcomes, as well as a higher number of patients reporting the perception of worsening symptoms and neurological deficits.
More opioid patients receive surgery compared to non-opioid patients. The use of opioid medications is linked to a higher likelihood of transitioning to surgical treatment and a lower likelihood of avoiding surgery. A decline in pain and quality of life is observed among individuals who use opioids.
Patients who experienced durotomy have significantly longer operative duration, increased blood loss during surgery, and a longer inpatient stay. Nevertheless, there are no disparities in the frequency of nerve root damage, postoperative death, supplementary surgeries, or in scores of BP, PF, or ODI at 1, 2, 3, or 4 years for patients who had durotomy.
Intra- and Inter-Reader Reliability of MRI Parameters
The classification of disc morphology shows significant intra- and inter-reader agreement, but there is only moderate reliability among readers when it comes to the assessment of thecal sac and nerve root compression.
Furthermore, quantitative measurements of canal and thecal sac area show good reliability. However, there is only modest reliability in measuring the area of the disc fragment. Clinical spine specialists and radiologists demonstrate excellent agreement in the identification of herniation level and location within the level when comparing MRI readings.
Risk factors for reherniation include younger age, absence of sensory and motor deficits, and higher baseline ODI scores. At the 8-year mark, the reoperation rate of patients who underwent surgery and were included in SPORT study is 15%. Reasons for reoperation included recurrent IDH (62%), complication or other factor (25%), and new condition (11%). Patients who were older and presented with asymmetric motor weakness were less likely to undergo reoperation.
Clinical Centers Impact
Variations are observed across centers in terms of patient age, race, baseline disability levels, and treatment preferences, leading to significant differences. Additionally, unadjusted reoperation rates differed across centers.
The rates of reoperation that are not adjusted for other factors also differed between centers. Although there are significant variations in the length of surgery, blood loss, and the incidence of durotomy across the centers, the long-term outcomes remain the same.
A greater number of patients showed a preference for surgical treatment. Younger patients with lower education levels and higher rates of unemployment or disability are more likely to prefer operative treatment.
Furthermore, these patients exhibited greater levels of pain, poorer physical and mental functioning, increased disability related to back pain, longer duration of symptoms, and higher usage of opioids. Patients who opt for physical therapy (PT) as a conservative treatment have higher disability scores and neurological deficits.
Patient expectations, especially their belief in the effectiveness of non-surgical treatment, is the most significant predictor of improvement with conservative management. This is also the main factor that influences the patient’s decision to choose surgery.
Patient expectations and preferences are significantly associated with other characteristics such as demographic factors, functional status, and prior treatment experience. Irrespective of the treatment modality chosen (surgical or non-surgical), patients with low expectations of surgery have poorer outcomes.
Conversely, those with high expectations of conservative treatment had better outcomes with non-surgical management. Positive associations with outcomes are clinically significant when patients have high expectations of either treatment.
Conservative management leads to significantly greater overall improvement over 4 years in BP, PF, and ODI for patients with higher levels of education. The effectiveness of surgery was reduced due to the successful nonoperative treatment in these patients.
Furthermore, higher levels of education were found to be significantly linked with greater improvement in nonoperative treatment, but not in operative outcomes. In addition, the success of nonoperative treatment in such patients led to a decrease in the comparative advantage of surgery.
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I am Vedant Vaksha, Fellowship trained Spine, Sports and Arthroscopic Surgeon at Complete Orthopedics. I take care of patients with ailments of the neck, back, shoulder, knee, elbow and ankle. I personally approve this content and have written most of it myself.
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