Limits...
Clinical outcomes of a polyaxial interspinous fusion system.

Sclafani JA, Liang K, Ohnmeiss DD, Gordon C - Int J Spine Surg (2014)

Bottom Line: There was a significant improvement in pain index score in the overall patient study group and a satisfactory (excellent or good) MacNab result was obtained in 48% of all patients.Patients with a BMI less than 30 had significantly better MacNab outcome classifications than patients with a BMI greater than 30.Patients with high pre-operative pain score and BMI under 30 can be predictors of better clinical outcome and should be considered prior to implantation.

View Article: PubMed Central - PubMed

Affiliation: Milestone Research Organization.

ABSTRACT

Background: Early interspinous process fixation constructs utilize rigid fixation plates with immobile spikes which increase the difficulty of device implantation when anatomic variations are encountered. Second generation systems have been designed with polyaxial properties with the goal of accommodating natural osseous anatomic variations to achieve optimal implant placement and fixation integrity. The purpose of this study was to evaluate clinical outcomes in patients treated with this device to supplement the biomechanical data from previous studies.

Methods: A retrospective, non-randomized, single-center chart review at or beyond the one year postoperative time point was conducted to collect preoperative and perioperative data on patients treated with a polyaxial intraspinous fixation system. A postoperative numerical pain rating scale and modified MacNab classification score were obtained from each patient in the cohort via phone survey.

Results: A total of 53 patients were included in the study. Median hospital stay was 2 days (range 1-7 days). There were no reported perioperative blood transfusions or cases of radiographic fracture/migration of the device at the 6 week post-operative time point. There was a significant improvement in pain index score in the overall patient study group and a satisfactory (excellent or good) MacNab result was obtained in 48% of all patients. Patients with preoperative pain scores greater than 8/10 reported more pain improvement than patients with preoperative pain scores less than 5 (0 points, p = 0.96, n = 8). Patients with a BMI less than 30 had significantly better MacNab outcome classifications than patients with a BMI greater than 30.

Conclusions: The polyaxial interspinous fusion system produces significant clinical improvement when employed to treat patients with stenosis, herniated disc, or low grade spondylolisthesis. This device can be implanted with a low complication rate and short postoperative hospital admission time. Patients with high pre-operative pain score and BMI under 30 can be predictors of better clinical outcome and should be considered prior to implantation.

No MeSH data available.


Related in: MedlinePlus

An interspinous process fusion device demonstrating polyaxial properties.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4325480&req=5

Figure 0001: An interspinous process fusion device demonstrating polyaxial properties.

Mentions: The OsteoMed PrimaLOK SP Interspinous Fusion System is a novel, second generation fusion device which employs multiple polyaxial features to better accommodate natural osseous anatomic variations and achieve optimal implant fixation integrity (Figure 1). An early cadaveric biomechanical study of this interspinous fusion system used as supplemental fixation demonstrated significantly reduced flexion-extension, lateral bending, and axial rotation range of motion compared to native segments under physiologic loads.13


Clinical outcomes of a polyaxial interspinous fusion system.

Sclafani JA, Liang K, Ohnmeiss DD, Gordon C - Int J Spine Surg (2014)

An interspinous process fusion device demonstrating polyaxial properties.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4325480&req=5

Figure 0001: An interspinous process fusion device demonstrating polyaxial properties.
Mentions: The OsteoMed PrimaLOK SP Interspinous Fusion System is a novel, second generation fusion device which employs multiple polyaxial features to better accommodate natural osseous anatomic variations and achieve optimal implant fixation integrity (Figure 1). An early cadaveric biomechanical study of this interspinous fusion system used as supplemental fixation demonstrated significantly reduced flexion-extension, lateral bending, and axial rotation range of motion compared to native segments under physiologic loads.13

Bottom Line: There was a significant improvement in pain index score in the overall patient study group and a satisfactory (excellent or good) MacNab result was obtained in 48% of all patients.Patients with a BMI less than 30 had significantly better MacNab outcome classifications than patients with a BMI greater than 30.Patients with high pre-operative pain score and BMI under 30 can be predictors of better clinical outcome and should be considered prior to implantation.

View Article: PubMed Central - PubMed

Affiliation: Milestone Research Organization.

ABSTRACT

Background: Early interspinous process fixation constructs utilize rigid fixation plates with immobile spikes which increase the difficulty of device implantation when anatomic variations are encountered. Second generation systems have been designed with polyaxial properties with the goal of accommodating natural osseous anatomic variations to achieve optimal implant placement and fixation integrity. The purpose of this study was to evaluate clinical outcomes in patients treated with this device to supplement the biomechanical data from previous studies.

Methods: A retrospective, non-randomized, single-center chart review at or beyond the one year postoperative time point was conducted to collect preoperative and perioperative data on patients treated with a polyaxial intraspinous fixation system. A postoperative numerical pain rating scale and modified MacNab classification score were obtained from each patient in the cohort via phone survey.

Results: A total of 53 patients were included in the study. Median hospital stay was 2 days (range 1-7 days). There were no reported perioperative blood transfusions or cases of radiographic fracture/migration of the device at the 6 week post-operative time point. There was a significant improvement in pain index score in the overall patient study group and a satisfactory (excellent or good) MacNab result was obtained in 48% of all patients. Patients with preoperative pain scores greater than 8/10 reported more pain improvement than patients with preoperative pain scores less than 5 (0 points, p = 0.96, n = 8). Patients with a BMI less than 30 had significantly better MacNab outcome classifications than patients with a BMI greater than 30.

Conclusions: The polyaxial interspinous fusion system produces significant clinical improvement when employed to treat patients with stenosis, herniated disc, or low grade spondylolisthesis. This device can be implanted with a low complication rate and short postoperative hospital admission time. Patients with high pre-operative pain score and BMI under 30 can be predictors of better clinical outcome and should be considered prior to implantation.

No MeSH data available.


Related in: MedlinePlus