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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

Oswestry Scores are graphically illustrated over time for the study and control population.
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Figure 0001: Oswestry Scores are graphically illustrated over time for the study and control population.

Mentions: Both groups showed significant functional improvement, although the incremental improvement over each interval was insignificant. For the entire group, the preoperative Oswestry score was 51.84. This improved to 37.05 by three months and 27.74 by 24 months. Figure 1 graphically illustrates the functional status of patients over time. The preoperative Oswestry score of the control group was 53.6 and improved to 38.6 at the 3-month interval and 30.4 by 24 months. The preoperative status of the study group was 50.5 and improved to 35.8 by the 3-month interval and 25.5 by 24 months. Both the improvement seen in the study group and control group reached criteria to be defined as a substantial clinical benefit defined as a 18.8 net improvement, 36.8% improvement or a final score of <31.5.9


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)

Oswestry Scores are graphically illustrated over time for the study and control population.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 0001: Oswestry Scores are graphically illustrated over time for the study and control population.
Mentions: Both groups showed significant functional improvement, although the incremental improvement over each interval was insignificant. For the entire group, the preoperative Oswestry score was 51.84. This improved to 37.05 by three months and 27.74 by 24 months. Figure 1 graphically illustrates the functional status of patients over time. The preoperative Oswestry score of the control group was 53.6 and improved to 38.6 at the 3-month interval and 30.4 by 24 months. The preoperative status of the study group was 50.5 and improved to 35.8 by the 3-month interval and 25.5 by 24 months. Both the improvement seen in the study group and control group reached criteria to be defined as a substantial clinical benefit defined as a 18.8 net improvement, 36.8% improvement or a final score of <31.5.9

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