Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion
Prospective, multicenter, randomized clinical trial. To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with o...
Uloženo v:
| Vydáno v: | Spine (Philadelphia, Pa. 1976) Ročník 40; číslo 10; s. 674 |
|---|---|
| Hlavní autoři: | , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
United States
15.05.2015
|
| Témata: | |
| ISSN: | 1528-1159, 1528-1159 |
| On-line přístup: | Zjistit podrobnosti o přístupu |
| Tagy: |
Přidat tag
Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!
|
| Abstract | Prospective, multicenter, randomized clinical trial.
To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion.
The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial.
Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years.
At 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P=0.001), neck pain (P=0.002), general health (Pphysical component summary=0.014; Pmental component summary=0.004), and patient satisfaction (P=0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P=0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF.
The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.
1. |
|---|---|
| AbstractList | Prospective, multicenter, randomized clinical trial.STUDY DESIGNProspective, multicenter, randomized clinical trial.To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion.OBJECTIVETo evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion.The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial.SUMMARY OF BACKGROUND DATAThe 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial.Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years.METHODSPatients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years.At 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P=0.001), neck pain (P=0.002), general health (Pphysical component summary=0.014; Pmental component summary=0.004), and patient satisfaction (P=0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P=0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF.RESULTSAt 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P=0.001), neck pain (P=0.002), general health (Pphysical component summary=0.014; Pmental component summary=0.004), and patient satisfaction (P=0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P=0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF.The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.CONCLUSIONThe long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.1.LEVEL OF EVIDENCE1. Prospective, multicenter, randomized clinical trial. To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion. The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial. Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years. At 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P=0.001), neck pain (P=0.002), general health (Pphysical component summary=0.014; Pmental component summary=0.004), and patient satisfaction (P=0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P=0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF. The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF. 1. |
| Author | Geisler, Fred H Reah, Christopher Gilder, Kye M McAfee, Paul C Howell, Kelli M Phillips, Frank M |
| Author_xml | – sequence: 1 givenname: Frank M surname: Phillips fullname: Phillips, Frank M organization: Midwest Orthopaedics at Rush University Medical Center, Chicago, IL †Chicago Back Institute, Chicago, IL ‡Kye Gilder Consulting, LLC, San Diego, CA §NuVasive, Inc., San Diego, CA; and ¶University of Maryland St. Joseph Medical Center, Baltimore, MD – sequence: 2 givenname: Fred H surname: Geisler fullname: Geisler, Fred H – sequence: 3 givenname: Kye M surname: Gilder fullname: Gilder, Kye M – sequence: 4 givenname: Christopher surname: Reah fullname: Reah, Christopher – sequence: 5 givenname: Kelli M surname: Howell fullname: Howell, Kelli M – sequence: 6 givenname: Paul C surname: McAfee fullname: McAfee, Paul C |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25955086$$D View this record in MEDLINE/PubMed |
| BookMark | eNpVkMtO7DAMhiME4v4GCHnJ4hSSdNI2y6HDANIgEBexHGVSlwlqk54kRRqeiYek3CTwwv4lf_ZveYesW2eRkANGjxmV-cnp7d0x_R1FJtfINhO8SBgTcv2X3iI7ITwPTJYyuUm2uJBCDAPb5G3m7FMS0bdw3UftWgzgaohLhIc7mE7GcDk5gxvvQoc6mhf8B7fKVq41r1hB6Wz0rmk-ZGOs0aqBe2-GXLq2U97YJ7gpr6BE__LZnJigYezj0ruuUSGu4NHEJYztcIFx_i84GLp2BYMdTPtgnN0jG7VqAu5_113yMD27Ly-S2fX5ZTmeJToVmUwY5pXErMgLpopacMl5Ude0KjCleZZXXCNVVGqhRwvMBNK64otRqkVep4KJBd8lR197O-_-9xjivP04p2mURdeHOcsKymku2WhAD7_RftFiNe-8aZVfzX8-zN8B6OOBaA |
| CitedBy_id | crossref_primary_10_1097_bn9_0000000000000002 crossref_primary_10_7759_cureus_59923 crossref_primary_10_1016_j_spinee_2023_12_004 crossref_primary_10_1016_j_spinee_2022_04_001 crossref_primary_10_3171_2022_2_SPINE2281 crossref_primary_10_3171_2019_10_SPINE19919 crossref_primary_10_1016_j_xnsj_2025_100768 crossref_primary_10_3389_fbioe_2020_00056 crossref_primary_10_1111_os_12401 crossref_primary_10_1093_neuros_nyaa459 crossref_primary_10_1016_j_recot_2023_06_016 crossref_primary_10_1186_s12891_020_03664_w crossref_primary_10_3171_CASE21320 crossref_primary_10_1097_BRS_0000000000001793 crossref_primary_10_1097_BRS_0000000000003453 crossref_primary_10_1097_MD_0000000000005947 crossref_primary_10_1007_s00586_016_4897_2 crossref_primary_10_1007_s12178_017_9396_5 crossref_primary_10_1186_s40064_016_2851_8 crossref_primary_10_1186_s12891_023_06215_1 crossref_primary_10_1097_BRS_0000000000003608 crossref_primary_10_1007_s12178_022_09791_2 crossref_primary_10_3171_2018_2_SPINE171378 crossref_primary_10_1097_BSD_0000000000000929 crossref_primary_10_7759_cureus_17282 crossref_primary_10_1097_BSD_0000000000001618 crossref_primary_10_3171_2018_7_SPINE18657 crossref_primary_10_3389_fsurg_2022_1000360 crossref_primary_10_3171_CASE21731 crossref_primary_10_1186_s12883_020_01717_0 crossref_primary_10_1097_BRS_0000000000003687 crossref_primary_10_1007_s00586_019_06175_y crossref_primary_10_1097_BRS_0000000000004811 crossref_primary_10_1016_j_spinee_2020_09_005 crossref_primary_10_1007_s00586_017_5204_6 crossref_primary_10_1097_BRS_0000000000003839 crossref_primary_10_1097_MD_0000000000005733 crossref_primary_10_1177_21925682231172982 crossref_primary_10_3390_life13102028 crossref_primary_10_1016_j_semss_2023_101067 crossref_primary_10_1007_s00586_019_06052_8 crossref_primary_10_1016_j_nec_2019_08_009 crossref_primary_10_1186_s13018_020_01957_3 crossref_primary_10_1016_j_wneu_2022_10_072 crossref_primary_10_3171_2018_9_SPINE18659 crossref_primary_10_1016_j_clineuro_2023_107933 crossref_primary_10_1371_journal_pone_0149312 crossref_primary_10_1007_s00586_019_06069_z crossref_primary_10_7759_cureus_74418 crossref_primary_10_1136_ebmed_2015_110239 crossref_primary_10_3171_2021_9_SPINE21904 crossref_primary_10_1080_17434440_2019_1593137 crossref_primary_10_1016_j_artd_2022_03_001 crossref_primary_10_1097_BRS_0000000000004888 crossref_primary_10_1002_jor_26095 crossref_primary_10_1177_2192568218765398 crossref_primary_10_1097_BRS_0000000000001537 crossref_primary_10_1007_s12178_017_9399_2 crossref_primary_10_3171_2022_2_SPINE22143 crossref_primary_10_1186_s13018_024_04679_y crossref_primary_10_1016_j_wneu_2016_07_065 crossref_primary_10_1016_j_biomaterials_2017_03_013 crossref_primary_10_1097_BSD_0000000000000946 crossref_primary_10_1111_os_12585 crossref_primary_10_3390_jcm13061589 crossref_primary_10_1302_0301_620X_100B8_BJJ_2018_0120_R1 crossref_primary_10_1097_BSD_0000000000001523 crossref_primary_10_5435_JAAOS_D_17_00231 crossref_primary_10_1016_j_wneu_2022_01_072 crossref_primary_10_1097_BSD_0000000000000552 crossref_primary_10_3390_met13020299 crossref_primary_10_1016_j_spinee_2023_10_020 crossref_primary_10_1016_j_wneu_2023_06_025 crossref_primary_10_1177_2192568217720681 crossref_primary_10_1097_BRS_0000000000004756 crossref_primary_10_1007_s00586_021_07092_9 crossref_primary_10_1097_BRS_0000000000003427 crossref_primary_10_1093_neuros_nyx304 crossref_primary_10_1097_BRS_0000000000004119 crossref_primary_10_1093_neuros_nyx424 crossref_primary_10_1097_BSD_0000000000001091 crossref_primary_10_1016_j_clineuro_2017_08_019 crossref_primary_10_1016_j_clinbiomech_2019_03_001 crossref_primary_10_1227_neu_0000000000002426 crossref_primary_10_1007_s00264_018_04281_y crossref_primary_10_1016_j_csm_2021_03_006 crossref_primary_10_1007_s12178_016_9349_4 crossref_primary_10_1016_j_wneu_2023_09_117 crossref_primary_10_1097_MD_0000000000011755 crossref_primary_10_1097_BSD_0000000000001537 crossref_primary_10_1097_BRS_0000000000003098 crossref_primary_10_1016_j_ijsu_2016_09_088 crossref_primary_10_1016_j_wneu_2019_12_129 crossref_primary_10_4274_jtss_galenos_2025_66587 crossref_primary_10_1097_BRS_0000000000002324 crossref_primary_10_1016_j_wneu_2018_02_113 crossref_primary_10_1097_BRS_0000000000001514 crossref_primary_10_1007_s00264_016_3181_8 crossref_primary_10_1016_j_spinee_2019_07_011 crossref_primary_10_31616_asj_2019_0234 crossref_primary_10_4184_asj_2018_12_1_178 crossref_primary_10_1097_BSD_0000000000000607 crossref_primary_10_1080_17434440_2018_1433533 crossref_primary_10_1097_MD_0000000000010015 crossref_primary_10_1177_21925682221125766 crossref_primary_10_1016_j_wneu_2016_12_125 crossref_primary_10_1016_j_wneu_2023_05_059 crossref_primary_10_1186_s13018_018_0940_9 crossref_primary_10_1097_BRS_0000000000002395 crossref_primary_10_1016_j_semss_2019_100774 crossref_primary_10_1007_s00402_024_05353_y crossref_primary_10_1097_BSD_0000000000001541 crossref_primary_10_4184_asj_2016_10_2_385 crossref_primary_10_1097_BRS_0000000000003524 crossref_primary_10_1097_BRS_0000000000003645 crossref_primary_10_1007_s00586_018_5570_8 crossref_primary_10_1097_BRS_0000000000002799 crossref_primary_10_1007_s00264_024_06328_9 crossref_primary_10_1016_j_nec_2021_05_009 crossref_primary_10_1016_j_spinee_2024_08_007 crossref_primary_10_1016_j_otsr_2016_10_008 crossref_primary_10_1016_j_spinee_2024_11_020 crossref_primary_10_1177_21925682251341812 crossref_primary_10_31616_asj_2019_0246 crossref_primary_10_3171_2019_8_SPINE19545 crossref_primary_10_1007_s00586_015_4258_6 crossref_primary_10_1007_s12178_017_9400_0 crossref_primary_10_1016_j_recot_2023_11_013 crossref_primary_10_1016_j_spinee_2021_08_006 crossref_primary_10_1186_s12891_019_2509_0 crossref_primary_10_1007_s12178_016_9348_5 crossref_primary_10_1177_2192568218755141 crossref_primary_10_1016_j_spinee_2017_06_010 crossref_primary_10_1016_j_spinee_2015_10_032 crossref_primary_10_3171_2015_12_SPINE15824 crossref_primary_10_1016_j_wneu_2020_07_054 crossref_primary_10_3390_jcm10184125 crossref_primary_10_1111_os_13917 crossref_primary_10_1016_j_nec_2021_05_001 crossref_primary_10_3171_2019_4_SPINE181468 crossref_primary_10_1016_j_nec_2021_05_003 crossref_primary_10_1093_neuros_nyx579 crossref_primary_10_1016_j_spinee_2017_10_072 crossref_primary_10_3171_2019_2_SPINE1956 crossref_primary_10_1007_s00586_017_5218_0 crossref_primary_10_1016_j_spinee_2018_04_021 crossref_primary_10_3171_2017_5_SPINE16824 crossref_primary_10_1016_j_wneu_2025_124145 crossref_primary_10_1097_BSD_0000000000000632 crossref_primary_10_3390_bioengineering9050227 crossref_primary_10_1186_s13018_025_06189_x crossref_primary_10_1016_j_clineuro_2017_12_004 crossref_primary_10_1097_BSD_0000000000000598 crossref_primary_10_1016_j_semss_2023_101020 crossref_primary_10_2147_JPR_S375720 crossref_primary_10_3171_2020_5_SPINE19442 |
| ContentType | Journal Article |
| DBID | CGR CUY CVF ECM EIF NPM 7X8 |
| DOI | 10.1097/BRS.0000000000000869 |
| DatabaseName | Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed MEDLINE - Academic |
| DatabaseTitle | MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) MEDLINE - Academic |
| DatabaseTitleList | MEDLINE - Academic MEDLINE |
| Database_xml | – sequence: 1 dbid: NPM name: PubMed url: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 2 dbid: 7X8 name: MEDLINE - Academic url: https://search.proquest.com/medline sourceTypes: Aggregation Database |
| DeliveryMethod | no_fulltext_linktorsrc |
| Discipline | Medicine |
| EISSN | 1528-1159 |
| ExternalDocumentID | 25955086 |
| Genre | Multicenter Study Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Journal Article |
| GeographicLocations | United States |
| GeographicLocations_xml | – name: United States |
| GroupedDBID | --- .-D .XZ .Z2 01R 0R~ 123 1J1 354 40H 4Q1 4Q2 4Q3 53G 5RE 5VS 6PF 71W 77Y 7O~ A9M AAAAV AAAXR AAGIX AAHPQ AAIQE AAJCS AAMOA AAMTA AAQKA AAQQT AARTV AASCR AASOK AAUEB AAWTL AAXQO ABASU ABBUW ABDIG ABJNI ABOCM ABVCZ ABXVJ ABXYN ABZAD ABZZY ACCJW ACDDN ACDOF ACEWG ACGFO ACGFS ACIJW ACILI ACLDA ACWDW ACWRI ACXJB ACXNZ ACZKN ADGGA ADHPY AE3 AE6 AEBDS AEETU AENEX AFBFQ AFDTB AFEXH AFMBP AFNMH AFSOK AFUWQ AGINI AHOMT AHQNM AHQVU AHVBC AIJEX AINUH AJCLO AJIOK AJNWD AJZMW AKCTQ AKULP ALKUP ALMA_UNASSIGNED_HOLDINGS ALMTX AMJPA AMKUR AMNEI AOHHW AOQMC BOYCO BQLVK BYPQX C45 CGR CS3 CUY CVF DIWNM DU5 E.X EBS ECM EEVPB EIF EJD ERAAH EX3 F2K F2L F2M F2N F5P FCALG FL- GNXGY GQDEL H0~ HLJTE HZ~ IKREB IKYAY IN~ IPNFZ JF9 JG8 JK3 JK8 K8S KD2 KMI L-C L7B N9A NPM N~7 N~B O9- OAG OAH ODMTH OHH OHYEH OL1 OLG OLH OLU OLV OLY OLZ OPUJH OVD OVDNE OVIDH OVLEI OVOZU OWBYB OWU OWV OWW OWX OWY OWZ OXXIT P2P R2J RIG RLZ S4R S4S SJN TEORI TSPGW V2I VVN W3M WH7 WOQ WOW X3V X3W XXN XYM YCJ YFH YOC ZB8 ZFV ZY1 ZZMQN 7X8 ABPXF ADKSD ADSXY |
| ID | FETCH-LOGICAL-c3569-1e7d9e68781a8f529228ff0d8e30767d2ce0a09c5c4be65e0fd2b43c57f3515b2 |
| IEDL.DBID | 7X8 |
| ISICitedReferencesCount | 175 |
| ISICitedReferencesURI | http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=000354110600009&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| ISSN | 1528-1159 |
| IngestDate | Mon Sep 08 15:34:14 EDT 2025 Thu Apr 03 07:10:27 EDT 2025 |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 10 |
| Language | English |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c3569-1e7d9e68781a8f529228ff0d8e30767d2ce0a09c5c4be65e0fd2b43c57f3515b2 |
| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 |
| PMID | 25955086 |
| PQID | 1680207914 |
| PQPubID | 23479 |
| ParticipantIDs | proquest_miscellaneous_1680207914 pubmed_primary_25955086 |
| PublicationCentury | 2000 |
| PublicationDate | 2015-May-15 |
| PublicationDateYYYYMMDD | 2015-05-15 |
| PublicationDate_xml | – month: 05 year: 2015 text: 2015-May-15 day: 15 |
| PublicationDecade | 2010 |
| PublicationPlace | United States |
| PublicationPlace_xml | – name: United States |
| PublicationTitle | Spine (Philadelphia, Pa. 1976) |
| PublicationTitleAlternate | Spine (Phila Pa 1976) |
| PublicationYear | 2015 |
| References | 26537354 - Evid Based Med. 2016 Feb;21(1):15 |
| References_xml | – reference: 26537354 - Evid Based Med. 2016 Feb;21(1):15 |
| SSID | ssj0006319 |
| Score | 2.5621216 |
| Snippet | Prospective, multicenter, randomized clinical trial.
To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior... Prospective, multicenter, randomized clinical trial.STUDY DESIGNProspective, multicenter, randomized clinical trial.To evaluate the long-term safety and... |
| SourceID | proquest pubmed |
| SourceType | Aggregation Database Index Database |
| StartPage | 674 |
| SubjectTerms | Biomechanical Phenomena Cervical Vertebrae - physiopathology Cervical Vertebrae - surgery Device Approval Disability Evaluation Diskectomy - adverse effects Diskectomy - methods Humans Neck Pain - diagnosis Neck Pain - etiology Neck Pain - surgery Pain Measurement Pain, Postoperative - diagnosis Pain, Postoperative - etiology Prosthesis Design Radiculopathy - complications Radiculopathy - diagnosis Radiculopathy - physiopathology Radiculopathy - surgery Recovery of Function Spinal Cord Diseases - complications Spinal Cord Diseases - diagnosis Spinal Cord Diseases - physiopathology Spinal Cord Diseases - surgery Spinal Fusion - adverse effects Spinal Fusion - methods Spondylosis - complications Spondylosis - diagnosis Spondylosis - physiopathology Spondylosis - surgery Time Factors Total Disc Replacement - adverse effects Total Disc Replacement - instrumentation Treatment Outcome United States United States Food and Drug Administration |
| Title | Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/25955086 https://www.proquest.com/docview/1680207914 |
| Volume | 40 |
| WOSCitedRecordID | wos000354110600009&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| hasFullText | |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwpV1La9wwEBZtU0ouaZs2TdIHU8ixIrYlWdIpbL1ZEshulzzavS22JKeGrJ2sdwvpb-qP7MgPQi-lUB-M8UMWzDDzaWY0HyEHqeFhJgWnJmCWculCil7RURtGqQ4Mc7zhOvx6JicTNZvpaRdwq7uyyt4mNobaVsbHyA_DWCGykTrkR7d31LNG-exqR6HxmGwwhDK-pEvOHrqFx6wh9kAXhSsl9Nv91jktDz-fX7StC_tDxX8BmY2zGT3_32m-IFsdzIRBqxcvySNXbpNn4y6R_or8OqvKa-rNMnxZr3BoV0OVA6JBuLqA0XAAp8NjmC6rfifmJzhPS1stip_OQtLWt9_4y25nJVx6TYakpTUsr2GajCFpDBHeHha18ZPxnAwI11f38K1YfYeBl2pRLf980ecRFveAv4PR2gfzXpOr0fFlckI74gZqmIg1DZ202sVKqjBVuYh0FKk8D6xyaFFiaSPjgjTQRhieuVi4ILdRxpkRMmeIr7Johzwpq9LtEnCOsdQE-DATnEUy1dyhz9WpMNK3zt8jH3s5zBd-ije-Rrha1_MHSeyRN60w57dtB485rvlwZabi_X_4-i3ZRJAkfMVAKN6RjRzNgntPnpofq6Jefmg0Ds-T6fg3DwXf3Q |
| linkProvider | ProQuest |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Long-term+Outcomes+of+the+US+FDA+IDE+Prospective%2C+Randomized+Controlled+Clinical+Trial+Comparing+PCM+Cervical+Disc+Arthroplasty+With+Anterior+Cervical+Discectomy+and+Fusion&rft.jtitle=Spine+%28Philadelphia%2C+Pa.+1976%29&rft.au=Phillips%2C+Frank+M&rft.au=Geisler%2C+Fred+H&rft.au=Gilder%2C+Kye+M&rft.au=Reah%2C+Christopher&rft.date=2015-05-15&rft.issn=1528-1159&rft.eissn=1528-1159&rft.volume=40&rft.issue=10&rft.spage=674&rft_id=info:doi/10.1097%2FBRS.0000000000000869&rft.externalDBID=NO_FULL_TEXT |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1528-1159&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1528-1159&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1528-1159&client=summon |