Table 2. Descriptive summary of eligible randomized trials of CDA versus ACDF for one- or two-level symptomatic cervical spondylosis.
Author (year) | Trial | Enrollment | Population | Intervention | Control | Outcomes | Last follow-up | Sponsor/funding |
---|---|---|---|---|---|---|---|---|
One-level | ||||||||
Heller et al. [2009] (12); Sasso et al. [2011] (13); Ghobrial et al. [2019] (14); Lavelle et al. [2019] (8) | Bryan, US FDA IDE | May 2002–October 2004 | N=463 | N=242 | N=221 | NDI | 10 years | Industry: Medtronic |
30 centers | CDA (Bryan) | ACDF with allograft and anterior plate | SF-36 | |||||
One-level spondylosis | Neck/arm pain VAS | |||||||
Radiculopathy or myelopathy | Neurological exam | |||||||
Refractory to 6 weeks of non-operative therapy, except myelopathy requiring immediate treatment | Work status | |||||||
Mean age: 44.4 yrs (CDA); 44.7 yrs (ACDF) | Adverse events | |||||||
Angular motion | ||||||||
Zhang et al. [2012] (15) | Bryan, China | May 2004–May 2006 | N=109 | N=56 | N=53 | NDI | 2 years | Non-industry: Chinese Medical Doctor Association |
3 centers | CDA (Bryan) | ACDF with allograft and anterior plate | Neck/arm pain VAS | |||||
One-level spondylosis, C3-7 | ROM | |||||||
Radiculopathy or myelopathy | Adverse events | |||||||
Refractory to 6 weeks of non-operative therapy | ||||||||
Mean age: 44.8 yrs (CDA); 45.6 yrs (ACDF) | ||||||||
Coric et al. [2011] (7); Coric et al. [2018] (16) | Kineflex|C, US FDA IDE | July 2005–January 2010 | N=269 | N=136 | N=133 | NDI | 5 years | Industry: SpinalMotion |
21 centers | CDA (Kineflex|C) | ACDF with allograft and anterior plate | Neck pain VAS | |||||
One-level spondylosis | Patient satisfaction | |||||||
Radiculopathy | Neurological exam | |||||||
Mean age: 43.7 yrs (CDA); 43.9 yrs (ACDF) | Adverse events | |||||||
Radiographic ASD | ||||||||
Angular motion | ||||||||
Activity level | ||||||||
Hisey et al. [2014] (17); Hisey et al. [2015] (18); Hisey et al. [2016] (19); Jackson et al. [2016] (6); Radcliff et al. [2017] (20) | Mobi-C, US FDA IDE | April 2006–March 2008 | N=245 | N=164 | N=81 | NDI | 7 years | Industry: LDR Spine |
23 centers | CDA (Mobi-C) | ACDF with allograft and anterior plate | SF-12 | |||||
One-level spondylosis, C3-7 | Angular motion | |||||||
Radiculopathy or myeloradiculopathy | Neurological exam | |||||||
Refractory to non-operative therapy for 6 weeks or progressive symptoms | Adverse events | |||||||
Mean age: 43.3 yrs (CDA); 44.0 yrs (ACDF) | ||||||||
Zhang et al. [2014] (21) | Mobi-C, China | February 2008–November 2009 | N=111 | N=55 | N=56 | JOA | 4 years | None |
11 centers | CDA (Mobi-C) | ACDF with cage and anterior plate | NDI | |||||
One-level spondylosis, C3-7 | Neck pain VAS | |||||||
Symptomatic | ROM | |||||||
Refractory to 3 months of non-operative therapy | Adverse events | |||||||
Mean age: 44.8 yrs (CDA); 46.7 yrs (ACDF) | ||||||||
Phillips et al. [2013] (25); Phillips et al. [2015] (26) | PCM, US FDA IDE | January 2005-December 2007 | N=403 | N=218 | N=185 | NDI | 7 years | Industry: NuVasive |
One-level spondylosis, C3-4 to C7-T1 | CDA (PCM) | ACDF with allograft and anterior plate | SF-36 | |||||
Radiculopathy or myelopathy | Neck/arm pain VAS | |||||||
Refractory to non-operative therapy | Neurological status | |||||||
May have undergone prior nonadjacent or adjacent single-level fusion | Adverse events | |||||||
Angular motion | ||||||||
Mummaneni et al. [2007] (30); Burkus et al. [2010] (31); Burkus et al. [2014] (32) | Prestige ST, US FDA IDE | October 2002–August 2004 | N=541 | N=276 | N=265 | NDI | 7 years | Industry: Medtronic |
32 centers | CDA (Prestige ST) | ACDF with allograft and anterior plate | Neck/arm pain VAS | |||||
One-level spondylosis, C3-7 | SF-36 | |||||||
Radiculopathy or myelopathy | Neurological exam | |||||||
Refractory to non-operative therapy (≥6 weeks) or progressive neurological worsening | Work status | |||||||
ROM | ||||||||
Adverse events | ||||||||
Secondary surgery | ||||||||
Murrey et al. [2009] (33); Delamarter et al. [2010] (34); Zigler et al. [2013] (36); Delamarter & Zigler [2013] (35); Janssen et al. [2015] (37) | ProDisc-C, US FDA IDE | August 2003–October 2004 | N=209 | N=103 | N=106 | NDI | 7 years | Industry: Synthes |
13 centers | CDA (ProDisc-C) | ACDF with allograft and anterior plate | Neck/arm pain VAS | |||||
One-level spondylosis, C3-7 | Patient satisfaction | |||||||
Radiculopathy | Neurological exam | |||||||
Refractory to non-operative therapy for at least 6 weeks | SF-36 | |||||||
Mean age: 42.1 yrs (CDA); 43.5 yrs (ACDF) | Adverse events | |||||||
Angular motion | ||||||||
Vaccaro et al. [2013]; Vaccaro et al. [2018] (38,39) | Secure-C, US FDA IDE | July 2005–April 2008 | N=291 | N=151 | N=140 | NDI | 7 years | Industry: Globus Medical |
18 centers | CDA (Secure-C) | ACDF with allograft and anterior plate | Neck/arm pain VAS | |||||
One-level spondylosis, C3-7 | Neurological status | |||||||
Radiculopathy or myelopathy | SF-36 | |||||||
Refractory to non-operative therapy (≥6 weeks) | Range of motion | |||||||
Mean age: 43.4 yrs (CDA); 44.4 yrs (ACDF) | ||||||||
Two-level | ||||||||
Davis et al. [2013] (22); Davis et al. [2015] (23); Jackson et al. [2016] (6); Radcliff et al. [2016] (24); Radcliff et al. [2017] (20) | Mobi-C, US FDA IDE | April 2006–March 2008 | N=330 | N=225 | N=105 | NDI | 7 years | Industry: LDR Medical |
24 centers | CDA (Mobi-C) | ACDF with allograft and anterior plate | SF-12 | |||||
Cervical spondylosis at two contiguous levels, C3-7 | Angular motion | |||||||
Radiculopathy or myeloradiculopathy | Neurological exam | |||||||
Refractory to 6 weeks of non-operative therapy | Adverse events | |||||||
Mean age: 45.3 yrs (CDA); 46.2 yrs (ACDF) | ||||||||
Gornet et al. [2017] (27); Lanman et al. [2017] (28); Gornet et al. [2019] (29) | Prestige LP, US FDA IDE | June 2006–November 2007 | N=397 | N=209 | N=188 | NDI | 10 years | Industry: Medtronic |
30 centers | CDA (Prestige LP) | ACDF with allograft and anterior plate | Neck/arm pain VAS | |||||
Cervical spondylosis at two contiguous levels, C3-7 | SF-36 | |||||||
Refractory to 6 weeks of non-operative therapy | Gait abnormality | |||||||
Mean age: 47.1 yrs (CDA); 47.3 yrs (ACDF) | ROM | |||||||
Neurological exam | ||||||||
Adverse events |
ACDF, anterior cervical discectomy and fusion; CDA, cervical disc arthroplasty; JOA, Japanese Orthopaedic Association score; NDI, Neck Disability Index; ROM, range of motion; SF-12, Short-Form 12; SF-36, Short-Form 36; VAS, visual analog scale.