A recent issue of the International Journal of Spine Surgery included the results of a multi-site minimally invasive prospective registry based on information from the minimally invasive transforaminal lumbar interbody fusion subgroup.
The researchers wanted to assess the validity and utility of the prospective spine registry. The data included 98 patients who were an average of 64.5 years old. The patients were followed for one year on average, and most underwent single-level procedures. There were 23 who underwent two-level surgery and three who underwent three-level procedures.
Here are five things to know about the study results:
1. The registry tracked preoperative and postoperative patient information with relatively short enrollment time. The primary surgical indications were:
• 27 percent: spondylolisthesis
• 25 percent: central stenosis
• 14 percent: foraminal stenosis
• 14 percent: post-laminectomy syndrome
• 6 percent: degenerative scoliosis
"Initial findings of the MIS Prospective Registry show patients can be enrolled in a relatively short time period and patient based questionnaires can successfully be obtained through a combination of clinic follow-up appointments and remote correspondence," concluded the study authors.
2. The outcomes were consistent with previously published MIS TLIF studies. Perioperative blood transfusion rate was 3 percent, and complications included intraoperative dural tear, deep wound infection and superficial dehiscence/cellulites. The researchers reported a 4 percent reoperation rate at the one-year postoperative mark. None of the complications were expected to have prolonged adverse effect on outcomes.
As the registry was effective, additional efforts on a larger scale and rare procedure subgroups could have a significant impact on future treatment. "A large registry will make analysis of less common spine pathologies that are not easily studied by traditional clinical trials feasible."
3. When the prospective registry fits seamlessly into the clinical practice workflow, data collection becomes easier and patient outcomes measures can be improved. By examining the registry data, the researchers found half of the patients were discharged within two days, and all patients that were discharged on the first day postoperatively underwent the single-level procedure. Those who went home the first day after surgery had significantly lower preoperative disability index score when compared with those who were discharged in three to five days.
Although there were only 98 patients reviewed for this study, the authors predict the case volume will grow in the future as more surgeons participate in the registry.
4. The average ODI scores were 46.5 preop and 26.2 at one year. There was significant improvement in the visual analog scale scores after one year, and patients with preoperative ODI scores greater than 50 demonstrated significant improvement starting at six weeks after surgery. Patients with preoperative ODI of 35 to 50 showed significant improvement starting at three months. Those with ODI score of less than 25 had an initial increased disability with a trend towards significant improvement by three months after surgery.
5. At one year after surgery, there were 35 percent of the patients who did not complete their follow-up survey at the routine office appointments. The study authors were able to capture 59 percent of the missing patient information through a total correspondence cost of $210, making it a cost-effective option for a data acquisition.
"Our attempt to collect missing data through email based correspondence was not successful. However, our method required the patient to print and return the completed questionnaire via the postal service. We hypothesize that email based methodologies of data acquisition will be more successful if the HRQOL questionnaire is propagated in a format that permits completion and submission through an entirely electronic based process," the authors concluded.
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