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Transforaminal Lumbar Interbody Fusion With rhBMP-2 in Spinal Deformity, Spondylolisthesis, and Degenerative Disease–Part 1: Large Series Diagnosis Related Outcomes and Complications With 2- to 9-Year Follow-up
STUDY DESIGN.Retrospective review of prospectively collected data. OBJECTIVE.To evaluate long-term clinical outcomes and complications of the transforaminal lumbar interbody fusion (TLIF) procedure from a large consecutive series, without industry funding. Clinical outcomes and complications are ana...
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Published in: | Spine (Philadelphia, Pa. 1976) Pa. 1976), 2013-06, Vol.38 (13), p.1128-1136 |
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creator | Crandall, Dennis G Revella, Jan Patterson, Jason Huish, Eric Chang, Michael McLemore, Ryan |
description | STUDY DESIGN.Retrospective review of prospectively collected data.
OBJECTIVE.To evaluate long-term clinical outcomes and complications of the transforaminal lumbar interbody fusion (TLIF) procedure from a large consecutive series, without industry funding. Clinical outcomes and complications are analyzed by diagnosis and primary versus revision surgery to assess whether TLIF with bone morphogenic protein (BMP) is appropriate for common use in deformity, spondylolisthesis, and degenerative disease.
SUMMARY OF BACKGROUND DATA.A common method for achieving spinal arthrodesis includes TLIF with a cage and off-label interbody BMP-2, supported by posterior arthrodesis and a pedicle screw construct. There are no large studies analyzing outcomes and complications after TLIF in different diagnoses, for primary and revision surgery, leading some to question the widespread use of TLIF.
METHODS.A total of 509 consecutive adults underwent open posterior instrumented fusion, augmented with TLIF at 872 discs using a cage and rhBMP-2, with minimum 2-year follow-up. Cohort diagnoses included 179 degenerative, 207 spondylolisthesis, and 123 deformity patients. Patient age averaged 61 years, 207 had undergone prior decompression or fusion surgery. All patients underwent posterior instrumented fusion and pedicle screw instrumentation at average 3.6 levels (range, 1–16); all patients had TLIF 1.7 levels (range, 1–4 levels) with BMP and autograft, stabilized with an interbody cage.
RESULTS.At average 59 months follow-up, 12 patients developed pseudoarthrosis, 8 at TLIF levels (8/872 discs, 0.92%) most commonly at L5–S1 (6/8). Significant clinical improvement was noted in patients with deformity, spondylolisthesis, and degenerative disease undergoing primary and revision surgery. Overall, visual analogue scale preoperative score was 6.6, at 1 year 3.8, at 2 years 3.5 (P < 0.001) and the preoperative ODI was 50.9, at 1 year 36.1, and at 2 years 35.0 (P < 0 0.001). Pain medication requirements also declined.
CONCLUSION.The efficacy of TLIF with BMP is supported in this large series with long-term follow-up, independent of industry. Reliable fusion and improved outcomes can be expected in adults undergoing TLIF for deformity, spondylolisthesis, and degenerative disease. Most complications occurred in patients with deformity.Level of Evidence3 |
doi_str_mv | 10.1097/BRS.0b013e31828864e6 |
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OBJECTIVE.To evaluate long-term clinical outcomes and complications of the transforaminal lumbar interbody fusion (TLIF) procedure from a large consecutive series, without industry funding. Clinical outcomes and complications are analyzed by diagnosis and primary versus revision surgery to assess whether TLIF with bone morphogenic protein (BMP) is appropriate for common use in deformity, spondylolisthesis, and degenerative disease.
SUMMARY OF BACKGROUND DATA.A common method for achieving spinal arthrodesis includes TLIF with a cage and off-label interbody BMP-2, supported by posterior arthrodesis and a pedicle screw construct. There are no large studies analyzing outcomes and complications after TLIF in different diagnoses, for primary and revision surgery, leading some to question the widespread use of TLIF.
METHODS.A total of 509 consecutive adults underwent open posterior instrumented fusion, augmented with TLIF at 872 discs using a cage and rhBMP-2, with minimum 2-year follow-up. Cohort diagnoses included 179 degenerative, 207 spondylolisthesis, and 123 deformity patients. Patient age averaged 61 years, 207 had undergone prior decompression or fusion surgery. All patients underwent posterior instrumented fusion and pedicle screw instrumentation at average 3.6 levels (range, 1–16); all patients had TLIF 1.7 levels (range, 1–4 levels) with BMP and autograft, stabilized with an interbody cage.
RESULTS.At average 59 months follow-up, 12 patients developed pseudoarthrosis, 8 at TLIF levels (8/872 discs, 0.92%) most commonly at L5–S1 (6/8). Significant clinical improvement was noted in patients with deformity, spondylolisthesis, and degenerative disease undergoing primary and revision surgery. Overall, visual analogue scale preoperative score was 6.6, at 1 year 3.8, at 2 years 3.5 (P < 0.001) and the preoperative ODI was 50.9, at 1 year 36.1, and at 2 years 35.0 (P < 0 0.001). Pain medication requirements also declined.
CONCLUSION.The efficacy of TLIF with BMP is supported in this large series with long-term follow-up, independent of industry. Reliable fusion and improved outcomes can be expected in adults undergoing TLIF for deformity, spondylolisthesis, and degenerative disease. Most complications occurred in patients with deformity.Level of Evidence3</description><identifier>ISSN: 0362-2436</identifier><identifier>EISSN: 1528-1159</identifier><identifier>DOI: 10.1097/BRS.0b013e31828864e6</identifier><identifier>PMID: 23370679</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins, Inc</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Bone Morphogenetic Protein 2 - adverse effects ; Bone Morphogenetic Protein 2 - therapeutic use ; Bone Screws ; Combined Modality Therapy ; Female ; Follow-Up Studies ; Humans ; Intervertebral Disc Degeneration - therapy ; Logistic Models ; Lumbar Vertebrae - surgery ; Male ; Middle Aged ; Pain Measurement ; Pain, Postoperative - etiology ; Pain, Postoperative - physiopathology ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Retrospective Studies ; Spinal Diseases - diagnosis ; Spinal Diseases - therapy ; Spinal Fusion - adverse effects ; Spinal Fusion - instrumentation ; Spinal Fusion - methods ; Spondylolisthesis - diagnosis ; Spondylolisthesis - therapy ; Time Factors ; Transforming Growth Factor beta - adverse effects ; Transforming Growth Factor beta - therapeutic use ; Treatment Outcome ; Young Adult</subject><ispartof>Spine (Philadelphia, Pa. 1976), 2013-06, Vol.38 (13), p.1128-1136</ispartof><rights>2013 Lippincott Williams & Wilkins, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3056-ff7cec9ea7c665fb0d19aa868c84778af900ba8d9a5ba019afdc00e1d34abcd93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23370679$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Crandall, Dennis G</creatorcontrib><creatorcontrib>Revella, Jan</creatorcontrib><creatorcontrib>Patterson, Jason</creatorcontrib><creatorcontrib>Huish, Eric</creatorcontrib><creatorcontrib>Chang, Michael</creatorcontrib><creatorcontrib>McLemore, Ryan</creatorcontrib><title>Transforaminal Lumbar Interbody Fusion With rhBMP-2 in Spinal Deformity, Spondylolisthesis, and Degenerative Disease–Part 1: Large Series Diagnosis Related Outcomes and Complications With 2- to 9-Year Follow-up</title><title>Spine (Philadelphia, Pa. 1976)</title><addtitle>Spine (Phila Pa 1976)</addtitle><description>STUDY DESIGN.Retrospective review of prospectively collected data.
OBJECTIVE.To evaluate long-term clinical outcomes and complications of the transforaminal lumbar interbody fusion (TLIF) procedure from a large consecutive series, without industry funding. Clinical outcomes and complications are analyzed by diagnosis and primary versus revision surgery to assess whether TLIF with bone morphogenic protein (BMP) is appropriate for common use in deformity, spondylolisthesis, and degenerative disease.
SUMMARY OF BACKGROUND DATA.A common method for achieving spinal arthrodesis includes TLIF with a cage and off-label interbody BMP-2, supported by posterior arthrodesis and a pedicle screw construct. There are no large studies analyzing outcomes and complications after TLIF in different diagnoses, for primary and revision surgery, leading some to question the widespread use of TLIF.
METHODS.A total of 509 consecutive adults underwent open posterior instrumented fusion, augmented with TLIF at 872 discs using a cage and rhBMP-2, with minimum 2-year follow-up. Cohort diagnoses included 179 degenerative, 207 spondylolisthesis, and 123 deformity patients. Patient age averaged 61 years, 207 had undergone prior decompression or fusion surgery. All patients underwent posterior instrumented fusion and pedicle screw instrumentation at average 3.6 levels (range, 1–16); all patients had TLIF 1.7 levels (range, 1–4 levels) with BMP and autograft, stabilized with an interbody cage.
RESULTS.At average 59 months follow-up, 12 patients developed pseudoarthrosis, 8 at TLIF levels (8/872 discs, 0.92%) most commonly at L5–S1 (6/8). Significant clinical improvement was noted in patients with deformity, spondylolisthesis, and degenerative disease undergoing primary and revision surgery. Overall, visual analogue scale preoperative score was 6.6, at 1 year 3.8, at 2 years 3.5 (P < 0.001) and the preoperative ODI was 50.9, at 1 year 36.1, and at 2 years 35.0 (P < 0 0.001). Pain medication requirements also declined.
CONCLUSION.The efficacy of TLIF with BMP is supported in this large series with long-term follow-up, independent of industry. Reliable fusion and improved outcomes can be expected in adults undergoing TLIF for deformity, spondylolisthesis, and degenerative disease. Most complications occurred in patients with deformity.Level of Evidence3</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Bone Morphogenetic Protein 2 - adverse effects</subject><subject>Bone Morphogenetic Protein 2 - therapeutic use</subject><subject>Bone Screws</subject><subject>Combined Modality Therapy</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Intervertebral Disc Degeneration - therapy</subject><subject>Logistic Models</subject><subject>Lumbar Vertebrae - surgery</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pain Measurement</subject><subject>Pain, Postoperative - etiology</subject><subject>Pain, Postoperative - physiopathology</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Retrospective Studies</subject><subject>Spinal Diseases - diagnosis</subject><subject>Spinal Diseases - therapy</subject><subject>Spinal Fusion - adverse effects</subject><subject>Spinal Fusion - instrumentation</subject><subject>Spinal Fusion - methods</subject><subject>Spondylolisthesis - diagnosis</subject><subject>Spondylolisthesis - therapy</subject><subject>Time Factors</subject><subject>Transforming Growth Factor beta - adverse effects</subject><subject>Transforming Growth Factor beta - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0362-2436</issn><issn>1528-1159</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNp9kc1u1DAUhSMEokPhDRDykkVT7Dh_ZkenDFQa1KpThFhFN87NxODYwXYYzY534NV4Ap4ElyksWLC60j3fOfdKJ0meMnrKqKhenF1vTmlLGUfO6qyuyxzLe8mCFVmdMlaI-8mC8jJLs5yXR8kj7z9RSkvOxMPkKOO8omUlFsmPGwfG99bBqAxosp7HFhy5MAFda7s9Wc1eWUM-qDAQN5y9u0ozogzZTL_xc4zWUYX9SdxY0-211cqHAb3yJwRMF4ktGnQQ1Fck58ojePz57fsVuEDYS7IGt0WyQafQRxm2xkYruUYNATtyOQdpxyjdRi3tOGklY5Q1_vBRlpJgiUg_Ynx6ZbW2u3SeHicPetAen9zN4-T96vXN8m26vnxzsXy1TiWnRZn2fSVRCoRKlmXRt7RjAqAua1nnVVVDLyhtoe4EFC3QqPWdpBRZx3NoZSf4cfL8kDs5-2VGH5pReYlag0E7-4bxoioo5aKIaH5ApbPeO-ybyakR3L5htLnts4l9Nv_2GW3P7i7M7YjdX9OfAiNQH4Cd1bEy_1nPO3TNgKDD8P_sX4r0s28</recordid><startdate>20130601</startdate><enddate>20130601</enddate><creator>Crandall, Dennis G</creator><creator>Revella, Jan</creator><creator>Patterson, Jason</creator><creator>Huish, Eric</creator><creator>Chang, Michael</creator><creator>McLemore, Ryan</creator><general>Lippincott Williams & Wilkins, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20130601</creationdate><title>Transforaminal Lumbar Interbody Fusion With rhBMP-2 in Spinal Deformity, Spondylolisthesis, and Degenerative Disease–Part 1: Large Series Diagnosis Related Outcomes and Complications With 2- to 9-Year Follow-up</title><author>Crandall, Dennis G ; Revella, Jan ; Patterson, Jason ; Huish, Eric ; Chang, Michael ; McLemore, Ryan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3056-ff7cec9ea7c665fb0d19aa868c84778af900ba8d9a5ba019afdc00e1d34abcd93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Bone Morphogenetic Protein 2 - adverse effects</topic><topic>Bone Morphogenetic Protein 2 - therapeutic use</topic><topic>Bone Screws</topic><topic>Combined Modality Therapy</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Intervertebral Disc Degeneration - therapy</topic><topic>Logistic Models</topic><topic>Lumbar Vertebrae - surgery</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pain Measurement</topic><topic>Pain, Postoperative - etiology</topic><topic>Pain, Postoperative - physiopathology</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Retrospective Studies</topic><topic>Spinal Diseases - diagnosis</topic><topic>Spinal Diseases - therapy</topic><topic>Spinal Fusion - adverse effects</topic><topic>Spinal Fusion - instrumentation</topic><topic>Spinal Fusion - methods</topic><topic>Spondylolisthesis - diagnosis</topic><topic>Spondylolisthesis - therapy</topic><topic>Time Factors</topic><topic>Transforming Growth Factor beta - adverse effects</topic><topic>Transforming Growth Factor beta - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Crandall, Dennis G</creatorcontrib><creatorcontrib>Revella, Jan</creatorcontrib><creatorcontrib>Patterson, Jason</creatorcontrib><creatorcontrib>Huish, Eric</creatorcontrib><creatorcontrib>Chang, Michael</creatorcontrib><creatorcontrib>McLemore, Ryan</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Spine (Philadelphia, Pa. 1976)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Crandall, Dennis G</au><au>Revella, Jan</au><au>Patterson, Jason</au><au>Huish, Eric</au><au>Chang, Michael</au><au>McLemore, Ryan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transforaminal Lumbar Interbody Fusion With rhBMP-2 in Spinal Deformity, Spondylolisthesis, and Degenerative Disease–Part 1: Large Series Diagnosis Related Outcomes and Complications With 2- to 9-Year Follow-up</atitle><jtitle>Spine (Philadelphia, Pa. 1976)</jtitle><addtitle>Spine (Phila Pa 1976)</addtitle><date>2013-06-01</date><risdate>2013</risdate><volume>38</volume><issue>13</issue><spage>1128</spage><epage>1136</epage><pages>1128-1136</pages><issn>0362-2436</issn><eissn>1528-1159</eissn><abstract>STUDY DESIGN.Retrospective review of prospectively collected data.
OBJECTIVE.To evaluate long-term clinical outcomes and complications of the transforaminal lumbar interbody fusion (TLIF) procedure from a large consecutive series, without industry funding. Clinical outcomes and complications are analyzed by diagnosis and primary versus revision surgery to assess whether TLIF with bone morphogenic protein (BMP) is appropriate for common use in deformity, spondylolisthesis, and degenerative disease.
SUMMARY OF BACKGROUND DATA.A common method for achieving spinal arthrodesis includes TLIF with a cage and off-label interbody BMP-2, supported by posterior arthrodesis and a pedicle screw construct. There are no large studies analyzing outcomes and complications after TLIF in different diagnoses, for primary and revision surgery, leading some to question the widespread use of TLIF.
METHODS.A total of 509 consecutive adults underwent open posterior instrumented fusion, augmented with TLIF at 872 discs using a cage and rhBMP-2, with minimum 2-year follow-up. Cohort diagnoses included 179 degenerative, 207 spondylolisthesis, and 123 deformity patients. Patient age averaged 61 years, 207 had undergone prior decompression or fusion surgery. All patients underwent posterior instrumented fusion and pedicle screw instrumentation at average 3.6 levels (range, 1–16); all patients had TLIF 1.7 levels (range, 1–4 levels) with BMP and autograft, stabilized with an interbody cage.
RESULTS.At average 59 months follow-up, 12 patients developed pseudoarthrosis, 8 at TLIF levels (8/872 discs, 0.92%) most commonly at L5–S1 (6/8). Significant clinical improvement was noted in patients with deformity, spondylolisthesis, and degenerative disease undergoing primary and revision surgery. Overall, visual analogue scale preoperative score was 6.6, at 1 year 3.8, at 2 years 3.5 (P < 0.001) and the preoperative ODI was 50.9, at 1 year 36.1, and at 2 years 35.0 (P < 0 0.001). Pain medication requirements also declined.
CONCLUSION.The efficacy of TLIF with BMP is supported in this large series with long-term follow-up, independent of industry. Reliable fusion and improved outcomes can be expected in adults undergoing TLIF for deformity, spondylolisthesis, and degenerative disease. Most complications occurred in patients with deformity.Level of Evidence3</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>23370679</pmid><doi>10.1097/BRS.0b013e31828864e6</doi><tpages>9</tpages></addata></record> |
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subjects | Adolescent Adult Aged Aged, 80 and over Bone Morphogenetic Protein 2 - adverse effects Bone Morphogenetic Protein 2 - therapeutic use Bone Screws Combined Modality Therapy Female Follow-Up Studies Humans Intervertebral Disc Degeneration - therapy Logistic Models Lumbar Vertebrae - surgery Male Middle Aged Pain Measurement Pain, Postoperative - etiology Pain, Postoperative - physiopathology Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Retrospective Studies Spinal Diseases - diagnosis Spinal Diseases - therapy Spinal Fusion - adverse effects Spinal Fusion - instrumentation Spinal Fusion - methods Spondylolisthesis - diagnosis Spondylolisthesis - therapy Time Factors Transforming Growth Factor beta - adverse effects Transforming Growth Factor beta - therapeutic use Treatment Outcome Young Adult |
title | Transforaminal Lumbar Interbody Fusion With rhBMP-2 in Spinal Deformity, Spondylolisthesis, and Degenerative Disease–Part 1: Large Series Diagnosis Related Outcomes and Complications With 2- to 9-Year Follow-up |
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