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Prospective randomized controlled trial of The Stabilis Stand Alone Cage (SAC) versus Bagby and Kuslich (BAK) implants for anterior lumbar interbody fusion.

Lavelle W, McLain RF, Rufo-Smith C, Gurd DP - Int J Spine Surg (2014)

Bottom Line: Adverse event rates did not differ between the groups.Functional scores from Owestry and SF-36 improved in both groups by the two-year follow-up.There were no significant differences between the SAC and BAK patients with respect to outcome.

View Article: PubMed Central - PubMed

Affiliation: SUNY Upstate Medical University, New York.

ABSTRACT

Background: Degenerative disc disease is common and debilitating for many patients. If conservative extensive care fails, anterior lumbar interbody fusion has proven to be an alternative form of surgical management. The Stabilis Stand Alone Cage(SAC) was introduced as a method to obtain stability and fusion. The purpose of this study was to determine whether the Stabilis Stand Alone Cage (SAC) is comparable in safety and efficacy to the Bagby and Kuslich (BAK) device.

Methods: As part of a prospective, randomized, controlled FDA trial, 73 patients underwent anterior interbody fusion using either the SAC(56%) or the BAK device (44%).

Results: Background characteristics were similar between the two groups. There was no significant difference between the SAC and BAK groups in mean operative time or mean blood loss during surgery. Adverse event rates did not differ between the groups. Assessment of plain radiographs could not confirm solid fusion in 63% of control and 71% of study patients. Functional scores from Owestry and SF-36 improved in both groups by the two-year follow-up. There were no significant differences between the SAC and BAK patients with respect to outcome.

Conclusions: Both the Stabilis Stand Alone Cage and the BAK Cage provided satisfactory improvement in function and pain relief, despite less than expected radiographic fusion rates. The apparent incongruency between fusion rates and functional outcomes suggests that either radiographs underestimate the true incidence of fusion, or that patients are obtaining good pain relief and improved function despite a lower rate of fusion than previously reported. This was a Level III study.

No MeSH data available.


Related in: MedlinePlus

Extension motion as measured on lateral X-rays over time is shown.
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Figure 0008: Extension motion as measured on lateral X-rays over time is shown.

Mentions: Radiographs of patients taken two years after the surgery were analyzed by independent radiologists. Data from the flexion and extension images are shown in Figure 7 and Figure 8. Of the 40 patients who were followed to 24 months, thirteen (32.5%) met the criteria to be determined as absolute fusion. Seven (36.8%) of these patients were from the control group and six (28.6%) were from the study group. There is no statistical difference between the two groups.


Prospective randomized controlled trial of The Stabilis Stand Alone Cage (SAC) versus Bagby and Kuslich (BAK) implants for anterior lumbar interbody fusion.

Lavelle W, McLain RF, Rufo-Smith C, Gurd DP - Int J Spine Surg (2014)

Extension motion as measured on lateral X-rays over time is shown.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4325498&req=5

Figure 0008: Extension motion as measured on lateral X-rays over time is shown.
Mentions: Radiographs of patients taken two years after the surgery were analyzed by independent radiologists. Data from the flexion and extension images are shown in Figure 7 and Figure 8. Of the 40 patients who were followed to 24 months, thirteen (32.5%) met the criteria to be determined as absolute fusion. Seven (36.8%) of these patients were from the control group and six (28.6%) were from the study group. There is no statistical difference between the two groups.

Bottom Line: Adverse event rates did not differ between the groups.Functional scores from Owestry and SF-36 improved in both groups by the two-year follow-up.There were no significant differences between the SAC and BAK patients with respect to outcome.

View Article: PubMed Central - PubMed

Affiliation: SUNY Upstate Medical University, New York.

ABSTRACT

Background: Degenerative disc disease is common and debilitating for many patients. If conservative extensive care fails, anterior lumbar interbody fusion has proven to be an alternative form of surgical management. The Stabilis Stand Alone Cage(SAC) was introduced as a method to obtain stability and fusion. The purpose of this study was to determine whether the Stabilis Stand Alone Cage (SAC) is comparable in safety and efficacy to the Bagby and Kuslich (BAK) device.

Methods: As part of a prospective, randomized, controlled FDA trial, 73 patients underwent anterior interbody fusion using either the SAC(56%) or the BAK device (44%).

Results: Background characteristics were similar between the two groups. There was no significant difference between the SAC and BAK groups in mean operative time or mean blood loss during surgery. Adverse event rates did not differ between the groups. Assessment of plain radiographs could not confirm solid fusion in 63% of control and 71% of study patients. Functional scores from Owestry and SF-36 improved in both groups by the two-year follow-up. There were no significant differences between the SAC and BAK patients with respect to outcome.

Conclusions: Both the Stabilis Stand Alone Cage and the BAK Cage provided satisfactory improvement in function and pain relief, despite less than expected radiographic fusion rates. The apparent incongruency between fusion rates and functional outcomes suggests that either radiographs underestimate the true incidence of fusion, or that patients are obtaining good pain relief and improved function despite a lower rate of fusion than previously reported. This was a Level III study.

No MeSH data available.


Related in: MedlinePlus