Evaluation of decompression and interlaminar stabilization compared with decompression and fusion for the treatment of lumbar spinal stenosis: 5-year follow-up of a prospective, randomized, controlled trial

Michael J. Musacchio, Carl Lauryssen, Reginald James Davis, Hyun W. Bae, John H. Peloza, Richard D. Guyer, Jack E. Zigler, Donna D. Ohnmeiss, Scott Leary

Research output: Contribution to journalArticle

Abstract

Introduction If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. Methods This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex® Interlaminar Stabilization® device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) > 15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. Results At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p > 0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p > 0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating > 15 point improvement (p > 0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. Conclusion Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels.

Original languageEnglish (US)
Article number6
JournalInternational Journal of Spine Surgery
Volume10
DOIs
StatePublished - 2015
Externally publishedYes

Fingerprint

Spinal Stenosis
Decompression
Randomized Controlled Trials
Equipment and Supplies
Pathologic Constriction
Reoperation
Therapeutics
Epidural Injections
Spondylolisthesis
United States Food and Drug Administration
Articular Range of Motion
Spine
Steroids
Outcome Assessment (Health Care)

Keywords

  • Clinical outcome
  • Decompression
  • Instrumented fusion
  • Interlaminar device
  • Lumbar spine
  • Randomized study
  • Spinal stenosis

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

Evaluation of decompression and interlaminar stabilization compared with decompression and fusion for the treatment of lumbar spinal stenosis : 5-year follow-up of a prospective, randomized, controlled trial. / Musacchio, Michael J.; Lauryssen, Carl; Davis, Reginald James; Bae, Hyun W.; Peloza, John H.; Guyer, Richard D.; Zigler, Jack E.; Ohnmeiss, Donna D.; Leary, Scott.

In: International Journal of Spine Surgery, Vol. 10, 6, 2015.

Research output: Contribution to journalArticle

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abstract = "Introduction If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. Methods This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex{\circledR} Interlaminar Stabilization{\circledR} device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) > 15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. Results At 5 years, 50.3{\%} of D+ILS vs. 44{\%} of D+PS patients (p > 0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3{\%} vs. 17.8{\%}; p > 0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6{\%} of D+ILS patients and 73.2{\%} of D+PS patients demonstrating > 15 point improvement (p > 0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. Conclusion Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels.",
keywords = "Clinical outcome, Decompression, Instrumented fusion, Interlaminar device, Lumbar spine, Randomized study, Spinal stenosis",
author = "Musacchio, {Michael J.} and Carl Lauryssen and Davis, {Reginald James} and Bae, {Hyun W.} and Peloza, {John H.} and Guyer, {Richard D.} and Zigler, {Jack E.} and Ohnmeiss, {Donna D.} and Scott Leary",
year = "2015",
doi = "10.14444/3006",
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volume = "10",
journal = "International Journal of Spine Surgery",
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T1 - Evaluation of decompression and interlaminar stabilization compared with decompression and fusion for the treatment of lumbar spinal stenosis

T2 - 5-year follow-up of a prospective, randomized, controlled trial

AU - Musacchio, Michael J.

AU - Lauryssen, Carl

AU - Davis, Reginald James

AU - Bae, Hyun W.

AU - Peloza, John H.

AU - Guyer, Richard D.

AU - Zigler, Jack E.

AU - Ohnmeiss, Donna D.

AU - Leary, Scott

PY - 2015

Y1 - 2015

N2 - Introduction If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. Methods This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex® Interlaminar Stabilization® device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) > 15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. Results At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p > 0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p > 0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating > 15 point improvement (p > 0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. Conclusion Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels.

AB - Introduction If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. Methods This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex® Interlaminar Stabilization® device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) > 15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. Results At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p > 0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p > 0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating > 15 point improvement (p > 0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. Conclusion Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels.

KW - Clinical outcome

KW - Decompression

KW - Instrumented fusion

KW - Interlaminar device

KW - Lumbar spine

KW - Randomized study

KW - Spinal stenosis

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