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Validation and analysis of a multi-site MIS Prospective Registry through sub-analysis of an MIS TLIF Subgroup.

Sclafani JA, Raiszadeh K, Raiszadeh R, Kim P, Doerr T, Siddiqi F, LaMotta I, Park P, Templin C, Gill S, Liang K, Kim CW - Int J Spine Surg (2014)

Bottom Line: Patients with pre-operative ODI scores greater than 50 demonstrated significant improvement starting at the 6 week post-operative time point (24 point improvement, n = 46, p < 0.001).A pre-operative ODI between 35-50 showed significant improvement starting at 3 months (15.5 point improvement, n = 29, p = 0.05).Patients with a pre-operative ODI score less than 35 had an initial period of increased disability with a trend towards significant improvement by 3 months post-op (n = 20).

View Article: PubMed Central - PubMed

Affiliation: Spine Institute of San Diego, Minimally Invasive Spine Center of Excellence.

ABSTRACT

Study design: Retrospective analysis of multi-site, prospectively collected database.

Objective: To assess the validity and utility of a prospective spine registry by sub-analysis of patients treated with MIS TLIF.

Background: The MIS registry is a large-scale, multi-center series of prospectively collected clinical information on outcomes, complications, and adverse events for minimally invasive spine procedures for the treatment of degenerative lumbar conditions.

Methods: Analysis was performed on the MIS Prospective Registry database. A subgroup of patients treated by MIS TLIF technique was identified. Statistical analyses were performed on pre and post-operative data collected using validated health related quality of life outcome tools. Missing 1-year patient follow-up data was obtained through progressive correspondence modalities.

Results: Data analysis was performed on 98 MIS TLIF patients (56 female, 42 male) with a median age of 64.5 years (range 25-91 years) which were extracted from a total registry population of 478 patients. The one year follow-up rate was 87%. A total of 64 single-level, 23 two-level, 3 three-level, and 3 combined TLIFs staged with an MIS lateral procedure were included. The primary surgical indications were spondylolisthesis (27%), central stenosis (25%), foraminal stenosis (14%), post-laminectomy syndrome (14%) and degenerative scoliosis (6%). The peri-operative blood transfusion rate was 3%. Complications included intraoperative dural tear (n = 3), deep wound infection (n = 2), superficial dehiscence/cellulitis (n = 2). There was a 4% re-operation rate at the 1 year post-operative time point. Half of patients were discharged within 2 days (range 1-11 days, mean 2.97 days, median 2 days). All patients that were discharged on the first post-operative day (n = 14) underwent a single-level MIS TLIF procedure and had significantly lower pre-op disability index score than those discharged on POD 3-5 (43.7 ± 15.5 vs. 56.0 ± 18.3, p = 0.04). Average ODI scores in the subgroup of patients that had reached the one year postoperative time point were 46.5 pre-op (n = 46), and 26.2 at 1 year post-op (n = 40, p = 0.0001). There was significant improvement in VAS scores: pre-operative (back = 6.7, leg = 5.4, n = 46), and 1 year post-operative (back = 3.2, leg = 1.7, n = 40, p = 0.0001). Patients with pre-operative ODI scores greater than 50 demonstrated significant improvement starting at the 6 week post-operative time point (24 point improvement, n = 46, p < 0.001). A pre-operative ODI between 35-50 showed significant improvement starting at 3 months (15.5 point improvement, n = 29, p = 0.05). Patients with a pre-operative ODI score less than 35 had an initial period of increased disability with a trend towards significant improvement by 3 months post-op (n = 20).

Conclusions: 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. Outcomes of the MIS Registry MIS TLIF subgroup were consistent with previously published MIS TLIF studies. Sub-analysis of data collected through level-specific patient diagnosis and treatment modalities permits outcome analysis of a wide breadth of spinal conditions and interventions.

No MeSH data available.


Related in: MedlinePlus

Algorithm detailing correspondence method used to obtain missing 1 year post-operative follow-up information. Email based surveys were sent to the remaining patients with missing information without any additional form acquisition.
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Figure 0004: Algorithm detailing correspondence method used to obtain missing 1 year post-operative follow-up information. Email based surveys were sent to the remaining patients with missing information without any additional form acquisition.

Mentions: At the time of data analysis there were 98 patients that had reached the 1 year post-operative time point. Complete patient questionnaire data was obtained for 64 of these patients through routine 1 year clinical follow-up appointments. Thirty-four patient questionnaires were mailed to patients that had incomplete 1 year data. Total postage and supply cost was $1.50 for each patient questionnaire packet. A total of 15 patients returned completed surveys after the initial round of correspondence. The next round of outreach provided a gift card to the remaining 19 patients upon receipt of a completed questionnaire. Three additional completed surveys were returned from the second round of US mail correspondence which offered a $20 incentive. Increasing the incentive to $50 via US mail resulted in one further completed survey returned to the study coordinator. Outreach to patients via an electronic questionnaire with a $20 incentive returned one survey. Increasing the electronic survey incentive to $50 did not result in any further surveys returned to the study coordinator (Figure 4).


Validation and analysis of a multi-site MIS Prospective Registry through sub-analysis of an MIS TLIF Subgroup.

Sclafani JA, Raiszadeh K, Raiszadeh R, Kim P, Doerr T, Siddiqi F, LaMotta I, Park P, Templin C, Gill S, Liang K, Kim CW - Int J Spine Surg (2014)

Algorithm detailing correspondence method used to obtain missing 1 year post-operative follow-up information. Email based surveys were sent to the remaining patients with missing information without any additional form acquisition.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4325489&req=5

Figure 0004: Algorithm detailing correspondence method used to obtain missing 1 year post-operative follow-up information. Email based surveys were sent to the remaining patients with missing information without any additional form acquisition.
Mentions: At the time of data analysis there were 98 patients that had reached the 1 year post-operative time point. Complete patient questionnaire data was obtained for 64 of these patients through routine 1 year clinical follow-up appointments. Thirty-four patient questionnaires were mailed to patients that had incomplete 1 year data. Total postage and supply cost was $1.50 for each patient questionnaire packet. A total of 15 patients returned completed surveys after the initial round of correspondence. The next round of outreach provided a gift card to the remaining 19 patients upon receipt of a completed questionnaire. Three additional completed surveys were returned from the second round of US mail correspondence which offered a $20 incentive. Increasing the incentive to $50 via US mail resulted in one further completed survey returned to the study coordinator. Outreach to patients via an electronic questionnaire with a $20 incentive returned one survey. Increasing the electronic survey incentive to $50 did not result in any further surveys returned to the study coordinator (Figure 4).

Bottom Line: Patients with pre-operative ODI scores greater than 50 demonstrated significant improvement starting at the 6 week post-operative time point (24 point improvement, n = 46, p < 0.001).A pre-operative ODI between 35-50 showed significant improvement starting at 3 months (15.5 point improvement, n = 29, p = 0.05).Patients with a pre-operative ODI score less than 35 had an initial period of increased disability with a trend towards significant improvement by 3 months post-op (n = 20).

View Article: PubMed Central - PubMed

Affiliation: Spine Institute of San Diego, Minimally Invasive Spine Center of Excellence.

ABSTRACT

Study design: Retrospective analysis of multi-site, prospectively collected database.

Objective: To assess the validity and utility of a prospective spine registry by sub-analysis of patients treated with MIS TLIF.

Background: The MIS registry is a large-scale, multi-center series of prospectively collected clinical information on outcomes, complications, and adverse events for minimally invasive spine procedures for the treatment of degenerative lumbar conditions.

Methods: Analysis was performed on the MIS Prospective Registry database. A subgroup of patients treated by MIS TLIF technique was identified. Statistical analyses were performed on pre and post-operative data collected using validated health related quality of life outcome tools. Missing 1-year patient follow-up data was obtained through progressive correspondence modalities.

Results: Data analysis was performed on 98 MIS TLIF patients (56 female, 42 male) with a median age of 64.5 years (range 25-91 years) which were extracted from a total registry population of 478 patients. The one year follow-up rate was 87%. A total of 64 single-level, 23 two-level, 3 three-level, and 3 combined TLIFs staged with an MIS lateral procedure were included. The primary surgical indications were spondylolisthesis (27%), central stenosis (25%), foraminal stenosis (14%), post-laminectomy syndrome (14%) and degenerative scoliosis (6%). The peri-operative blood transfusion rate was 3%. Complications included intraoperative dural tear (n = 3), deep wound infection (n = 2), superficial dehiscence/cellulitis (n = 2). There was a 4% re-operation rate at the 1 year post-operative time point. Half of patients were discharged within 2 days (range 1-11 days, mean 2.97 days, median 2 days). All patients that were discharged on the first post-operative day (n = 14) underwent a single-level MIS TLIF procedure and had significantly lower pre-op disability index score than those discharged on POD 3-5 (43.7 ± 15.5 vs. 56.0 ± 18.3, p = 0.04). Average ODI scores in the subgroup of patients that had reached the one year postoperative time point were 46.5 pre-op (n = 46), and 26.2 at 1 year post-op (n = 40, p = 0.0001). There was significant improvement in VAS scores: pre-operative (back = 6.7, leg = 5.4, n = 46), and 1 year post-operative (back = 3.2, leg = 1.7, n = 40, p = 0.0001). Patients with pre-operative ODI scores greater than 50 demonstrated significant improvement starting at the 6 week post-operative time point (24 point improvement, n = 46, p < 0.001). A pre-operative ODI between 35-50 showed significant improvement starting at 3 months (15.5 point improvement, n = 29, p = 0.05). Patients with a pre-operative ODI score less than 35 had an initial period of increased disability with a trend towards significant improvement by 3 months post-op (n = 20).

Conclusions: 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. Outcomes of the MIS Registry MIS TLIF subgroup were consistent with previously published MIS TLIF studies. Sub-analysis of data collected through level-specific patient diagnosis and treatment modalities permits outcome analysis of a wide breadth of spinal conditions and interventions.

No MeSH data available.


Related in: MedlinePlus