Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale
BACKGROUND:Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM. OBJECTIVE:To determine whether ventral surgery is associated with superior...
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| Veröffentlicht in: | Neurosurgery 2014-10, Vol.75 (4), p.334-346 |
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| creator | Ghogawala, Zoher Benzel, Edward C Heary, Robert F Riew, K Daniel Albert, Todd J Butler, William E Barker, Fred G Heller, John G McCormick, Paul C Whitmore, Robert G Freund, Karen M Schwartz, J Sanford |
| description | BACKGROUND:Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM.
OBJECTIVE:To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures.
METHODS:The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use.
EXPECTED OUTCOMES:This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM.
DISCUSSION:A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.
ABBREVIATIONS:CSM, cervical spondylotic myelopathyCSM-S, Cervical Spondylotic Myelopathy-SurgicalEQ-5D, EuroQOL 5-dimension questionnaireHIPAA, Health Insurance Portability and Accountability ActIRB, Institutional Review BoardNDI, Neck Disability IndexNIH, National Institutes of HealthPCORI, Patient-Centered Outcomes Research InstitutePCS, Physical Component SummaryPI, principal investigatorQOL, quality of lifeRCT, randomized clinical trialSF-36, Short Form-36 |
| doi_str_mv | 10.1227/NEU.0000000000000479 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4633023</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2357434381</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3889-e1da49a151df01580795b31f08f651238956bd2a02359c05203cdf698031aac23</originalsourceid><addsrcrecordid>eNp9kd1PFDEUxRujkQX5D4iZxBcfGOztx0zrg4lZUElQEz4S3ppu29ktdqdrOwNZ_nqLCwR58L7ch_O7J-fmILQH-AAIaT_8OLo4wE-HtfIFmgAnrGaY4ZdogoGJmsrmcgtt53yFMTSsFa_RFmFSQgtsgvTUpWtvdKjOVrG36xAHb6rvaxfiSg-LdXU2pvlf_Tx5HT5Wp7q3celvnd2vprEfUgzB2Y1aHbrs531VkMINPvY6uDfoVadDdrv3ewddfDk6n36rT35-PZ5-PqkNFULWDqxmUgMH22HgAreSzyh0WHQNB0KF5M3MEo0J5dJgTjA1tmukwBS0NoTuoE8b39U4WzprXMmmg1olv9RpraL26l-l9ws1j9eKNZQW12Lw_t4gxd-jy4Na-mxcCLp3ccwKeENliYHv0HfP0Ks4pvJtViVeyyijAgrFNpRJMefkuscwgNVdh6p0qJ53WM7ePn3k8eihtAKIDXATw-BS_hXGG5fUwukwLP7v_Qfy9ahH</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2357434381</pqid></control><display><type>article</type><title>Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale</title><source>MEDLINE</source><source>Journals@Ovid Complete</source><creator>Ghogawala, Zoher ; Benzel, Edward C ; Heary, Robert F ; Riew, K Daniel ; Albert, Todd J ; Butler, William E ; Barker, Fred G ; Heller, John G ; McCormick, Paul C ; Whitmore, Robert G ; Freund, Karen M ; Schwartz, J Sanford</creator><creatorcontrib>Ghogawala, Zoher ; Benzel, Edward C ; Heary, Robert F ; Riew, K Daniel ; Albert, Todd J ; Butler, William E ; Barker, Fred G ; Heller, John G ; McCormick, Paul C ; Whitmore, Robert G ; Freund, Karen M ; Schwartz, J Sanford</creatorcontrib><description>BACKGROUND:Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM.
OBJECTIVE:To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures.
METHODS:The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use.
EXPECTED OUTCOMES:This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM.
DISCUSSION:A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.
ABBREVIATIONS:CSM, cervical spondylotic myelopathyCSM-S, Cervical Spondylotic Myelopathy-SurgicalEQ-5D, EuroQOL 5-dimension questionnaireHIPAA, Health Insurance Portability and Accountability ActIRB, Institutional Review BoardNDI, Neck Disability IndexNIH, National Institutes of HealthPCORI, Patient-Centered Outcomes Research InstitutePCS, Physical Component SummaryPI, principal investigatorQOL, quality of lifeRCT, randomized clinical trialSF-36, Short Form-36</description><identifier>ISSN: 0148-396X</identifier><identifier>EISSN: 1524-4040</identifier><identifier>DOI: 10.1227/NEU.0000000000000479</identifier><identifier>PMID: 24991714</identifier><language>eng</language><publisher>United States: Copyright by the Congress of Neurological Surgeons</publisher><subject>Aged ; Decompression, Surgical - methods ; Humans ; Male ; Middle Aged ; Neurosurgery ; Neurosurgical Procedures - methods ; Patient Outcome Assessment ; Quality of Life ; Research Design ; Spinal Cord Diseases - surgery ; Spondylosis - complications ; Spondylosis - surgery ; Surgery ; Surveys and Questionnaires ; Treatment Outcome ; United States</subject><ispartof>Neurosurgery, 2014-10, Vol.75 (4), p.334-346</ispartof><rights>Copyright © by the Congress of Neurological Surgeons</rights><rights>2014 by the Congress of Neurological Surgeons</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3889-e1da49a151df01580795b31f08f651238956bd2a02359c05203cdf698031aac23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,781,785,886,27928,27929</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24991714$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ghogawala, Zoher</creatorcontrib><creatorcontrib>Benzel, Edward C</creatorcontrib><creatorcontrib>Heary, Robert F</creatorcontrib><creatorcontrib>Riew, K Daniel</creatorcontrib><creatorcontrib>Albert, Todd J</creatorcontrib><creatorcontrib>Butler, William E</creatorcontrib><creatorcontrib>Barker, Fred G</creatorcontrib><creatorcontrib>Heller, John G</creatorcontrib><creatorcontrib>McCormick, Paul C</creatorcontrib><creatorcontrib>Whitmore, Robert G</creatorcontrib><creatorcontrib>Freund, Karen M</creatorcontrib><creatorcontrib>Schwartz, J Sanford</creatorcontrib><title>Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale</title><title>Neurosurgery</title><addtitle>Neurosurgery</addtitle><description>BACKGROUND:Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM.
OBJECTIVE:To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures.
METHODS:The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use.
EXPECTED OUTCOMES:This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM.
DISCUSSION:A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.
ABBREVIATIONS:CSM, cervical spondylotic myelopathyCSM-S, Cervical Spondylotic Myelopathy-SurgicalEQ-5D, EuroQOL 5-dimension questionnaireHIPAA, Health Insurance Portability and Accountability ActIRB, Institutional Review BoardNDI, Neck Disability IndexNIH, National Institutes of HealthPCORI, Patient-Centered Outcomes Research InstitutePCS, Physical Component SummaryPI, principal investigatorQOL, quality of lifeRCT, randomized clinical trialSF-36, Short Form-36</description><subject>Aged</subject><subject>Decompression, Surgical - methods</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neurosurgery</subject><subject>Neurosurgical Procedures - methods</subject><subject>Patient Outcome Assessment</subject><subject>Quality of Life</subject><subject>Research Design</subject><subject>Spinal Cord Diseases - surgery</subject><subject>Spondylosis - complications</subject><subject>Spondylosis - surgery</subject><subject>Surgery</subject><subject>Surveys and Questionnaires</subject><subject>Treatment Outcome</subject><subject>United States</subject><issn>0148-396X</issn><issn>1524-4040</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kd1PFDEUxRujkQX5D4iZxBcfGOztx0zrg4lZUElQEz4S3ppu29ktdqdrOwNZ_nqLCwR58L7ch_O7J-fmILQH-AAIaT_8OLo4wE-HtfIFmgAnrGaY4ZdogoGJmsrmcgtt53yFMTSsFa_RFmFSQgtsgvTUpWtvdKjOVrG36xAHb6rvaxfiSg-LdXU2pvlf_Tx5HT5Wp7q3celvnd2vprEfUgzB2Y1aHbrs531VkMINPvY6uDfoVadDdrv3ewddfDk6n36rT35-PZ5-PqkNFULWDqxmUgMH22HgAreSzyh0WHQNB0KF5M3MEo0J5dJgTjA1tmukwBS0NoTuoE8b39U4WzprXMmmg1olv9RpraL26l-l9ws1j9eKNZQW12Lw_t4gxd-jy4Na-mxcCLp3ccwKeENliYHv0HfP0Ks4pvJtViVeyyijAgrFNpRJMefkuscwgNVdh6p0qJ53WM7ePn3k8eihtAKIDXATw-BS_hXGG5fUwukwLP7v_Qfy9ahH</recordid><startdate>201410</startdate><enddate>201410</enddate><creator>Ghogawala, Zoher</creator><creator>Benzel, Edward C</creator><creator>Heary, Robert F</creator><creator>Riew, K Daniel</creator><creator>Albert, Todd J</creator><creator>Butler, William E</creator><creator>Barker, Fred G</creator><creator>Heller, John G</creator><creator>McCormick, Paul C</creator><creator>Whitmore, Robert G</creator><creator>Freund, Karen M</creator><creator>Schwartz, J Sanford</creator><general>Copyright by the Congress of Neurological Surgeons</general><general>Wolters Kluwer Health, 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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201410</creationdate><title>Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale</title><author>Ghogawala, Zoher ; Benzel, Edward C ; Heary, Robert F ; Riew, K Daniel ; Albert, Todd J ; Butler, William E ; Barker, Fred G ; Heller, John G ; McCormick, Paul C ; Whitmore, Robert G ; Freund, Karen M ; Schwartz, J Sanford</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3889-e1da49a151df01580795b31f08f651238956bd2a02359c05203cdf698031aac23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Aged</topic><topic>Decompression, Surgical - methods</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neurosurgery</topic><topic>Neurosurgical Procedures - methods</topic><topic>Patient Outcome Assessment</topic><topic>Quality of Life</topic><topic>Research Design</topic><topic>Spinal Cord Diseases - surgery</topic><topic>Spondylosis - complications</topic><topic>Spondylosis - surgery</topic><topic>Surgery</topic><topic>Surveys and Questionnaires</topic><topic>Treatment Outcome</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ghogawala, Zoher</creatorcontrib><creatorcontrib>Benzel, Edward C</creatorcontrib><creatorcontrib>Heary, Robert F</creatorcontrib><creatorcontrib>Riew, K Daniel</creatorcontrib><creatorcontrib>Albert, Todd J</creatorcontrib><creatorcontrib>Butler, William E</creatorcontrib><creatorcontrib>Barker, Fred G</creatorcontrib><creatorcontrib>Heller, John G</creatorcontrib><creatorcontrib>McCormick, Paul C</creatorcontrib><creatorcontrib>Whitmore, Robert G</creatorcontrib><creatorcontrib>Freund, Karen M</creatorcontrib><creatorcontrib>Schwartz, J Sanford</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Neurosurgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ghogawala, Zoher</au><au>Benzel, Edward C</au><au>Heary, Robert F</au><au>Riew, K Daniel</au><au>Albert, Todd J</au><au>Butler, William E</au><au>Barker, Fred G</au><au>Heller, John G</au><au>McCormick, Paul C</au><au>Whitmore, Robert G</au><au>Freund, Karen M</au><au>Schwartz, J Sanford</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale</atitle><jtitle>Neurosurgery</jtitle><addtitle>Neurosurgery</addtitle><date>2014-10</date><risdate>2014</risdate><volume>75</volume><issue>4</issue><spage>334</spage><epage>346</epage><pages>334-346</pages><issn>0148-396X</issn><eissn>1524-4040</eissn><abstract>BACKGROUND:Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM.
OBJECTIVE:To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures.
METHODS:The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use.
EXPECTED OUTCOMES:This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM.
DISCUSSION:A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.
ABBREVIATIONS:CSM, cervical spondylotic myelopathyCSM-S, Cervical Spondylotic Myelopathy-SurgicalEQ-5D, EuroQOL 5-dimension questionnaireHIPAA, Health Insurance Portability and Accountability ActIRB, Institutional Review BoardNDI, Neck Disability IndexNIH, National Institutes of HealthPCORI, Patient-Centered Outcomes Research InstitutePCS, Physical Component SummaryPI, principal investigatorQOL, quality of lifeRCT, randomized clinical trialSF-36, Short Form-36</abstract><cop>United States</cop><pub>Copyright by the Congress of Neurological Surgeons</pub><pmid>24991714</pmid><doi>10.1227/NEU.0000000000000479</doi><tpages>13</tpages></addata></record> |
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| ispartof | Neurosurgery, 2014-10, Vol.75 (4), p.334-346 |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Aged Decompression, Surgical - methods Humans Male Middle Aged Neurosurgery Neurosurgical Procedures - methods Patient Outcome Assessment Quality of Life Research Design Spinal Cord Diseases - surgery Spondylosis - complications Spondylosis - surgery Surgery Surveys and Questionnaires Treatment Outcome United States |
| title | Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale |
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