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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

Disc Height at the L5-S1 as measured on lateral X-rays over time is shown.
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Figure 0010: Disc Height at the L5-S1 as measured on lateral X-rays over time is shown.

Mentions: The SAC device appeared to better resist subsidence, at least at the L4-L5 disc space. Disc height was measured at each postoperative evaluation and is graphically illustrated in Figure 9 and Figure 10. Two-week radiographs show good distraction of the affected disc space in both groups. The control group L4-L5 disc height was 16.3mm and L5-S1 disc height was 19.0mm, compared to 17.0mm and 20.6mm respectively for the study group. The three-month radiographs show mild changes. At six months, the L4-L5 disc space measures 11.8mm for the control group and 17.2mm for the study group. The loss of disc height in the control group versus the study group was statistically significant. L5-S1 disc space height decreased to 15.3mm for the control group and 17.4mm for the study group. By one year, the L4-L5 disc height had decreased 28.8% for the control group and 1.2% for the study group. The L5-S1 disc height had decreased 17.4% for the control group and 20.9% for the study group. No significant changes occurred after the six-month period.


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)

Disc Height at the L5-S1 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 0010: Disc Height at the L5-S1 as measured on lateral X-rays over time is shown.
Mentions: The SAC device appeared to better resist subsidence, at least at the L4-L5 disc space. Disc height was measured at each postoperative evaluation and is graphically illustrated in Figure 9 and Figure 10. Two-week radiographs show good distraction of the affected disc space in both groups. The control group L4-L5 disc height was 16.3mm and L5-S1 disc height was 19.0mm, compared to 17.0mm and 20.6mm respectively for the study group. The three-month radiographs show mild changes. At six months, the L4-L5 disc space measures 11.8mm for the control group and 17.2mm for the study group. The loss of disc height in the control group versus the study group was statistically significant. L5-S1 disc space height decreased to 15.3mm for the control group and 17.4mm for the study group. By one year, the L4-L5 disc height had decreased 28.8% for the control group and 1.2% for the study group. The L5-S1 disc height had decreased 17.4% for the control group and 20.9% for the study group. No significant changes occurred after the six-month period.

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