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Expandable Polyaryl-Ether-Ether-Ketone Spacers for Interbody Distraction in the Lumbar Spine.

Alimi M, Shin B, Macielak M, Hofstetter CP, Njoku I, Tsiouris AJ, Elowitz E, Härtl R - Global Spine J (2015)

Bottom Line: PEEK implants have been successfully used as interbody devices.There was a significant increase in the average disk height (6.49 versus 8.18 mm, p = 0.037) and foraminal height (15.6 versus 18.53 mm, p = 0.0001), and a significant reduction in the listhesis (5.13 versus 3.15 mm, p = 0.005).Conclusions Midterm results indicate that expandable PEEK spacers can effectively and durably restore disk and foraminal height and improve the outcome without significant subsidence.

View Article: PubMed Central - PubMed

Affiliation: Weill Cornell Brain and Spine Center, Department of Neurological Surgery, Weill Cornell Medical College, New York-Presbyterian Hospital, New York, New York, United States.

ABSTRACT
Study Design Retrospective case series. Objective StaXx XD (Spine Wave, Inc., Shelton, CT, United States) is an expandable polyaryl-ether-ether-ketone (PEEK) wafer implant utilized in the treatment of lumbar degenerative disease. PEEK implants have been successfully used as interbody devices. Few studies have focused on expandable PEEK devices. The aim of the current study is to determine the radiographic and clinical outcome of expandable PEEK cages utilized for transforaminal lumbar interbody fusion in patients with lumbar degenerative diseases. Methods Forty-nine patients who underwent lumbar interbody fusion with implantation of expandable PEEK cages and posterior instrumentation were included. The clinical outcome was evaluated using the visual analog scale (VAS) and the Oswestry Disability Index (ODI). Radiographic parameters including disk height, foraminal height, listhesis, local disk angle of the index level/levels, regional lumbar lordosis, and graft subsidence were measured preoperatively, postoperatively, and at latest follow-up. Results At an average follow-up of 19.3 months, the minimum clinically important difference for the ODI and VAS back, buttock, and leg were achieved in 64, 52, 58, and 52% of the patients, respectively. There was statistically significant improvement in VAS back (6.42 versus 3.11, p < 0.001), VAS buttock (4.66 versus 1.97, p = 0.002), VAS leg (4.55 versus 1.96, p < 0.001), and ODI (21.7 versus 12.1, p < 0.001) scores. There was a significant increase in the average disk height (6.49 versus 8.18 mm, p = 0.037) and foraminal height (15.6 versus 18.53 mm, p = 0.0001), and a significant reduction in the listhesis (5.13 versus 3.15 mm, p = 0.005). The subsidence of 0.66 mm (7.4%) observed at the latest follow-up was not significant (p = 0.35). Conclusions Midterm results indicate that expandable PEEK spacers can effectively and durably restore disk and foraminal height and improve the outcome without significant subsidence.

No MeSH data available.


Related in: MedlinePlus

Radiologic outcomes of 45/49 patients at the latest follow-up on average 19.3 months. Average disk height and average foraminal height were significantly improved. NS, not significant. *p = 0.026; **p = 0.0001; †p = 0.35; ***p = 0.0001.
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FI1400011or-4: Radiologic outcomes of 45/49 patients at the latest follow-up on average 19.3 months. Average disk height and average foraminal height were significantly improved. NS, not significant. *p = 0.026; **p = 0.0001; †p = 0.35; ***p = 0.0001.

Mentions: Based on the inclusion and exclusion criteria, all 49 patients who underwent lumbar interbody fusion using expandable StaXx XD PEEK spacer and bilateral pedicle screw instrumentation between 2009 and 2011 were eligible for inclusion. All met the pathology criteria, and there were no cases with tumor. Of the patients, 72% had minimally invasive transforaminal lumbar interbody fusion procedures (MIS TLIF) and 28% had open revision surgeries for outside referrals and other indications. The demographics and surgical details are summarized in Tables 1 and 2, respectively. Clinical and radiographic outcome are reported in Tables 34 to 5 and Figs. 34 to 5.


Expandable Polyaryl-Ether-Ether-Ketone Spacers for Interbody Distraction in the Lumbar Spine.

Alimi M, Shin B, Macielak M, Hofstetter CP, Njoku I, Tsiouris AJ, Elowitz E, Härtl R - Global Spine J (2015)

Radiologic outcomes of 45/49 patients at the latest follow-up on average 19.3 months. Average disk height and average foraminal height were significantly improved. NS, not significant. *p = 0.026; **p = 0.0001; †p = 0.35; ***p = 0.0001.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4472284&req=5

FI1400011or-4: Radiologic outcomes of 45/49 patients at the latest follow-up on average 19.3 months. Average disk height and average foraminal height were significantly improved. NS, not significant. *p = 0.026; **p = 0.0001; †p = 0.35; ***p = 0.0001.
Mentions: Based on the inclusion and exclusion criteria, all 49 patients who underwent lumbar interbody fusion using expandable StaXx XD PEEK spacer and bilateral pedicle screw instrumentation between 2009 and 2011 were eligible for inclusion. All met the pathology criteria, and there were no cases with tumor. Of the patients, 72% had minimally invasive transforaminal lumbar interbody fusion procedures (MIS TLIF) and 28% had open revision surgeries for outside referrals and other indications. The demographics and surgical details are summarized in Tables 1 and 2, respectively. Clinical and radiographic outcome are reported in Tables 34 to 5 and Figs. 34 to 5.

Bottom Line: PEEK implants have been successfully used as interbody devices.There was a significant increase in the average disk height (6.49 versus 8.18 mm, p = 0.037) and foraminal height (15.6 versus 18.53 mm, p = 0.0001), and a significant reduction in the listhesis (5.13 versus 3.15 mm, p = 0.005).Conclusions Midterm results indicate that expandable PEEK spacers can effectively and durably restore disk and foraminal height and improve the outcome without significant subsidence.

View Article: PubMed Central - PubMed

Affiliation: Weill Cornell Brain and Spine Center, Department of Neurological Surgery, Weill Cornell Medical College, New York-Presbyterian Hospital, New York, New York, United States.

ABSTRACT
Study Design Retrospective case series. Objective StaXx XD (Spine Wave, Inc., Shelton, CT, United States) is an expandable polyaryl-ether-ether-ketone (PEEK) wafer implant utilized in the treatment of lumbar degenerative disease. PEEK implants have been successfully used as interbody devices. Few studies have focused on expandable PEEK devices. The aim of the current study is to determine the radiographic and clinical outcome of expandable PEEK cages utilized for transforaminal lumbar interbody fusion in patients with lumbar degenerative diseases. Methods Forty-nine patients who underwent lumbar interbody fusion with implantation of expandable PEEK cages and posterior instrumentation were included. The clinical outcome was evaluated using the visual analog scale (VAS) and the Oswestry Disability Index (ODI). Radiographic parameters including disk height, foraminal height, listhesis, local disk angle of the index level/levels, regional lumbar lordosis, and graft subsidence were measured preoperatively, postoperatively, and at latest follow-up. Results At an average follow-up of 19.3 months, the minimum clinically important difference for the ODI and VAS back, buttock, and leg were achieved in 64, 52, 58, and 52% of the patients, respectively. There was statistically significant improvement in VAS back (6.42 versus 3.11, p < 0.001), VAS buttock (4.66 versus 1.97, p = 0.002), VAS leg (4.55 versus 1.96, p < 0.001), and ODI (21.7 versus 12.1, p < 0.001) scores. There was a significant increase in the average disk height (6.49 versus 8.18 mm, p = 0.037) and foraminal height (15.6 versus 18.53 mm, p = 0.0001), and a significant reduction in the listhesis (5.13 versus 3.15 mm, p = 0.005). The subsidence of 0.66 mm (7.4%) observed at the latest follow-up was not significant (p = 0.35). Conclusions Midterm results indicate that expandable PEEK spacers can effectively and durably restore disk and foraminal height and improve the outcome without significant subsidence.

No MeSH data available.


Related in: MedlinePlus