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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

SF-36 Mental Component Scores are graphically depicted over time for the study and control population.
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Figure 0002: SF-36 Mental Component Scores are graphically depicted over time for the study and control population.

Mentions: The preoperative SF-36 score for the entire group was 7.88. This improved to 18.44 by three months and 46.25 by 24 months. Figure 2 and Figure 3 graphically illustrate the SF-36 results over time. The control group had a preoperative score of 8.6, which improved to 19.2 by three months and 41.7 by 24 months. The study group had a preoperative score of 7.3, which improved to 17.9 by three months and 50.0 by 24 months. This again represented a substantial clinical benefit defined as a 6.2 net improvement, 19.4% improvement of a final score of > 35.1.9


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)

SF-36 Mental Component Scores are graphically depicted 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 0002: SF-36 Mental Component Scores are graphically depicted over time for the study and control population.
Mentions: The preoperative SF-36 score for the entire group was 7.88. This improved to 18.44 by three months and 46.25 by 24 months. Figure 2 and Figure 3 graphically illustrate the SF-36 results over time. The control group had a preoperative score of 8.6, which improved to 19.2 by three months and 41.7 by 24 months. The study group had a preoperative score of 7.3, which improved to 17.9 by three months and 50.0 by 24 months. This again represented a substantial clinical benefit defined as a 6.2 net improvement, 19.4% improvement of a final score of > 35.1.9

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