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SUPPLEMENTAL DIGITAL MATERIAL
Demographic table
|Author |Study design |Population |Purpose |Inclusion/exclusion |Treatment or risk factor|How ASP defined |
|(Year) | | | | | |and classified |
|RCTs comparing Bryan disc to fusion |
|Sasso (2011) |Randomized |N = 463 |Evaluate |Inclusion: Age ≥21 years; single level |Arthroplasty and |RASP: NR |
| |controlled trial |Male: 48% |clinical functional outcomes four |cervical degenerative disc disease |insertion of Bryan disc |CASP: NR |
| | |Mean age: 44.6 (range |years after either Bryan cervical |causing radiculopathy or myelopathy from |(n=242 enrolled; n=230 |CASP requiring treatment: |
| |31 investigational |25-78) years |disc arthroplasty or anterior |C3-C7; failure of conservative care for 6|at 24 months; n=181 at |Reported reoperation at adjacent |
| |sites | |cervical discectomy and fusion, |weeks (except myelopathy cases needing |48 months) |levels due to CASP; if procedures |
| | |F/U: |with an emphasis on assessing any |immediate attention); NDI ≥30%. | |involved both index and adjacent |
| |1:1 randomization |68.9% (319/463) |deterioration in outcomes over | |ACDF with an allograft |levels, they were reported for index |
| | |Length of F/U: |time. |Exclusion: Presence of moderate to |and single anterior |level only. |
| |Conflict: |48 months | |advanced spondylosis; radiographic signs |cervical titanium alloy | |
| |One or more of the | | |of subluxation (>3.5mm) or angulation |plating system (n=221 | |
| |authors received | | |(11°); marked reduction or absence of |enrolled; n=194 at 24 | |
| |payments or services| | |motion or collapse of the intervertebral |months; n=138 at 48 | |
| |in support of this | | |disc space > 50% normal height; facet |months) | |
| |work, has had a | | |joint arthrosis; segmental instability or| | |
| |financial | | |cervical kyphosis; active infection; | | |
| |relationship in the | | |metabolic bone disease; known allergy to | | |
| |36 months prior to | | |titanium, polyurethane, or ethylene oxide| | |
| |submission of this | | |residuals; concomitant conditions | | |
| |work with an entity | | |requiring steroid treatment; diabetes | | |
| |in the biomedical | | |mellitus; extreme obesity; pregnancy; | | |
| |arena that could be | | |inflammatory spondyloarthropathies such | | |
| |perceived to | | |as ankylosing spondylitis or rheumatoid | | |
| |influence what is | | |arthritis; previous cervical spine | | |
| |written in this | | |surgery. | | |
| |work, or has engaged| | | | | |
| |in another activity | | | | | |
| |that could be | | | | | |
| |perceived influence | | | | | |
| |what is written in | | | | | |
| |this work. | | | | | |
|Zhang (2011) |Randomized |N = 109 |Compare clinical and radiographic |Inclusion: Followed inclusion/exclusion |C-TDR with Bryan disc |RASP: NR |
| |controlled trial |Male: 55.8% |outcomes of cervical disc |criteria of US FDA IDE study (Anderson/ |(n=60 enrolled; n=56 at |CASP: NR |
| | |Mean age: TDR=44.8±5.6 |arthroplasty with those of ACDF in |Sasso). Symptomatic mild degenerative |F/U) |CASP requiring treatment: Reported |
| |1:1 randomization |(range 32-59) yrs; |a Chinese population |disc disease at one cervical level; disc |ACDF (n=60 enrolled; |reoperations due to CASP |
| | |ACDF=45.6±5.8 (range | |herniation with radiculopathy caused by |n=53 at F/U) | |
| |3 sites in China |31-62) yrs | |foraminal osteophytes, soft disc | | |
| | | | |herniation, or myelopathy; no response to| | |
| |Conflict: NR |F/U: 90.8% (109/120) | |≥ 6 weeks of treatment. | | |
| | |Length of F/U: | | | | |
| | |24 months | |Exclusion: Axial neck pain as a solitary | | |
| | | | |symptom; contraindications for TDR, | | |
| | | | |including incompetent posterior elements,| | |
| | | | |instability or severe facet arthrosis; | | |
| | | | |insufficient cervical motion at the index| | |
| | | | |level; bridging osteophytes; collapse of | | |
| | | | |intervertebral disc space of > 50% of | | |
| | | | |normal height; severe osteoporosis | | |
|RCT comparing Prestige disc to fusion |
|Burkus (2010) |Randomized |N = 541 |Burkus: Investigate the long-term |Inclusion: Age >18 years, single-level |TDR with Prestige |RASP: NR |
| |controlled trial |Male: 46.2% |safety and efficacy of the Prestige|symptomatic degenerative disc disease |cervical disc prosthesis|CASP: NR |
| | |Mean age: Prestige=43.3 |disc at 5-years in patients |from C3-C7 and intractable radiculopathy |(n=276 enrolled, n=223 |CASP requiring treatment: Reported |
| |32 US |(range 25-72) years; |undergoing single-level anterior |and/or myelopathy; NDI scores ≥30; |at 24-months; n=144 at |reoperation at adjacent levels for |
| |investigational |ACDF=43.9 (range 22-73) |cervical discectomy and disc |numeric neck pain scores ≥ 20; ≥6 wk h/o |60 months) |CASP |
| |sites |years |arthroplasty with Prestige compared|neck and arm pain recalcitrant to | | |
| | | |to patients underoing single-level |nonoperative treatment; surgery performed|ACDF using allograft | |
| |1:1 randomization |F/U: |fusion. |in 3.5 mm or sagittal-plane angulation >20°| | |
| | | | |at a single level; symptomatic C2–3 or | | |
| | | | |C7–T1 disc disease; previous surgery at | | |
| | | | |involved level; severe facet joint | | |
| | | | |disease at involved level; h/o discitis; | | |
| | | | |osteoporosis, measured with DEXA; | | |
| | | | |metastases; medical condition that | | |
| | | | |required long-term use of medication that| | |
| | | | |could affect bone quality and fusion | | |
| | | | |rates. | | |
|RCT comparing Kineflex/C disc to fusion |
|Coric (2011) |Randomized clinical |N = 269 |Compare the clinical and |Inclusion: Age 18-60 yrs; symptomatic |Kineflex/C-TDR (n=136 |RASP: Quantitative analysis of disc |
| |trial |Male: 40.9% |radiographic outcomes of the |cervical degenerative disc disease/ |enrolled; n=119 at F/U) |height and independent radiologist’s |
| | |Mean age: 43.8 ±7.6 |Kineflex/C, a metal-on-metal C-TDR |spondylosis at only 1 level from C3-C7 | |subjective assessments of extent of |
| |21 institutions |(range 23-62) years |implant vs ACDF for the treatment |including ≥1 of the following: |ACDF with allograft and |osteophyte formation and degree of |
| | | |of single-level spondylosis with |degenerated/ dark disc on MRI, disc |anterior plate (n=133 |endplate sclerosis, classified as |
| |1:1 randomization |F/U: 87.0% (234/269) |radiculopathy in patients with a |height decreased by ≥1 mm when compared |enrolled; n=115 at F/U) |none, mild, moderate, severe (based on|
| | |Length of F/U: |minimum of 2-year follow-up. |w/ adjacent levels on radiography, disc | |Walraevens et al, Eur Spine J |
| | |24 months | |herniation on CT or MRI; 1 of the | |18:358-369, 2009)*. For cases with |
| |Conflict: Authors | | |following radiculopathy symptoms in neck,| |pre-existing moderate RASP, a 1-grade |
| |have consulted for, | | |1 or both shoulders, &/or 1 or both arms:| |change was required for classification|
| |stock or direct | | |pain or paresthesias in a specific nerve | |as RASP; for other cases, a 2-grade |
| |ownership in, patent| | |root distribution from C3-C7, decreased | |increase in degeneration was |
| |ownership in, | | |muscle strength ≥1 level on 0–5 scale, | |classified as RASP. |
| |received clinical or| | |abnormal sensation, including hyper- or | |CASP: NR |
| |research support | | |hypo-esthesia; ≥1 of the following: ≥6 | |CASP requiring treatment: Reported |
| |from, received | | |mos of prior conservative treatment, | |reoperation at adjacent levels for |
| |statistical analysis| | |presence of progressive symptoms (e.g., | |CASP |
| |and/or writing | | |increasing numbness or tingling), signs | | |
| |assistance from | | |of nerve root compression; NDI ≥40 | |* Classification of RASP: |
| |SpinalMotion, Inc, | | |(moderate disability); | |None- negligible disc space narrowing,|
| |Pioneer Surgical, | | |appropriate for treatment using an | |no osteophyte formation, no endplate |
| |Spinal Wave, DePuy | | |anterior surgical approach; likely to | |sclerosis |
| |Spine, Spinal | | |return for all follow-up visits; willing | |Mild: 3mm or >11° | |moderate endplate sclerosis |
| | | | |rotation compared w/ adjacent levels); | |Severe: >66% disc space narrowing, |
| | | | |nondiscogenic neck pain or nondiscogenic | |severe osteophyte formation, moderate |
| | | | |source of symptoms (e.g. tumor, rotator | |to severe endplate sclerosis |
| | | | |cuff injury); radiographic confirmation | | |
| | | | |of severe facet disease or facet | | |
| | | | |degeneration; | | |
| | | | |bridging osteophytes; 1 vertebral level requiring | | |
| | | | |treatment; marked cervical instability on| | |
| | | | |resting lateral or flexion-extension | | |
| | | | |radiographs (translation >3mm, >11° | | |
| | | | |rotational difference to that or either | | |
| | | | |adjacent level); fused level adjacent to | | |
| | | | |level being treated; radiographic | | |
| | | | |confirmation of severe facet joint | | |
| | | | |disease or degeneration; known allergy to| | |
| | | | |cobalt, chromium, molybdenum, titanium or| | |
| | | | |polyethylene; prior surgery at level to | | |
| | | | |be treated; neck or arm pain of unknown | | |
| | | | |etiology; clinically compromised | | |
| | | | |vertebral bodies at the affected level | | |
| | | | |secondary to trauma (e.g. radiographic | | |
| | | | |appearance of fracture callus, malunion | | |
| | | | |or nonunion); active local or systemic | | |
| | | | |infection; severe spondylosis at level to| | |
| | | | |be treated characterized by bridging | | |
| | | | |osteophytes, >50% loss of disc height, | | |
| | | | |5 | | |
| | | | |years. | | |
|Nabhan (2007b) |Randomized |N = 49 |Investigate segmental motion |Inclusion: Age 20-60 years; one-level |ProDisc-C (n=25 |RASP: NR |
| |controlled trial |Male: 56.1% |following implantation of the |cervical disc disease between C3-C7; |enrolled; n=20 at F/U) |CASP: NR |
| | |Mean age: 44 years |ProDisc-C cervical spine disc |Unresponsive to conservative treatment or|ACDF (n=24 enrolled; |CASP requiring treatment: Reported |
| |Conflict: No funds | |prosthesis vs ACDF using a solis |presence or signs of nerve root |n=21 at F/U) |adjacent level reoperation |
| |were received in |F/U: 83.7% (41/49) |cage and anterior titanium plate 36|compression with paresis; soft disc | | |
| |support of this |Length of F/U: |months after surgery. |herniation; clinical evidence of | | |
| |work. No benefits in|36 months | |radiculopathy; signed consent form | | |
| |any form have been | | | | | |
| |or will be received | | |Exclusion: Marked cervical instability on| | |
| |from a commercial | | |resting or flexion-extension radiographs | | |
| |party related | | |(translation >3mm, >11° rotational | | |
| |directly or | | |difference to that or either adjacent | | |
| |indirectly to the | | |level); more than 1 level of pathology; | | |
| |subject of this | | |myelopathy; radiographic confirmation of | | |
| |manuscript. | | |severe facet joint degeneration; hard | | |
| | | | |disc disease; osteoporosis, infection, | | |
| | | | |rheumatoid arthritis; spondylodiscitis | | |
| | | | |and active infection; malignant disease; | | |
| | | | |systemic disease, such as HIV, AIDS, | | |
| | | | |hepatitis; known allergy to cobalt, | | |
| | | | |chromium, molybdenum, titanium or | | |
| | | | |polyethylene; traumatic injury of spine; | | |
| | | | |pregnant or possible pregnancy in the | | |
| | | | |next 3 years | | |
|Prospective cohort studies comparing motion-sparing devices to fusion |
|Kim (2009) |Prospective Cohort |N = 105 |Compare the clinical and radiologic|Inclusion: Patients with symptomatic |Bryan disc (n=51) |RASP: Presence of new anterior or |
| | |Male: 60.0% |outcomes of patients who underwent |single or two-level cervical disc disease|ACDF with autogenous |enlarging osteophyte, increase or new |
| |Conflict: NR |Mean age: |ACDF or Bryan cervical disc | |bone and different types|≥30% narrowing of disc space, and/or |
| | |Bryan=43.9 yrs; |arthroplasty in single and bi-level|Exclusion: NR |of anterior cervical |calcification of the anterior |
| | |ACDF=46.4 yrs |cases and evaluate ongoing | |plates or stand-alone |longitudinal ligament in adjacent |
| | | |processes and underlying changes at| |cages (n=54) |segment(s) |
| | |F/U: NR% |the adjacent level during the | | |CASP: NR |
| | |Mean F/U: 19 (range |follow-up period | | | |
| | |12-40) months | | | | |
| | | | | | | |
|Maldonado (2011) |Prospective cohort |N = 208 |Evaluate the incidence of RASP in |Inclusion: Age > 18 years, with |TDA with the Discocerv |RASP: Development of new anterior |
| | |Male: 40.0% |patients with cervical degenerative|single-level symptomatic DDD between C-3 |or Discover device (n=NR|osteophyte formation or enlargement of|
| | |Mean age: CDA=46.9±6.9 |disc disease (DDD) who underwent |and C-7 and intractable radiculopathy |enrolled; n=85 at F/U) |existing osteophytes, increased or new|
| |Conflict: |years; ACDF=46.5±6.4 |cervical disc arthroplasty (CDA) |or/and myelopathy; unresponsive to ≥ 6 | |narrowing of a disc space (> 30%), new|
| |“None of the authors|years |compared to ACDF with a minimum |weeks of nonsurgical management or |ACDF using cages with |or increased calcification of the |
| |has any potential | |follow-up of 3 years. |developed a new neurologic deficit |allograft bone (n=NR |anterior longitudinal ligament and the|
| |conflict of |F/U: 91.3% (190/208) | |secondary to myelopathy. |enrolled; n=105 at F/U) |formation of radial osteophytes. |
| |interest.” |Length of F/U: | | | |CASP: NR |
| | |36 months | |Exclusion: Evidence of cervical | | |
| | | | |instability on dynamic flexion–extension | | |
| | | | |radiographs or sagittal-plane angulation | | |
| | | | |greater than +20° at a single level; | | |
| | | | |previous surgery at the involved level; | | |
| | | | |severe cervical spondylosis consisting of| | |
| | | | |disc-space narrowing, osteophytosis, loss| | |
| | | | |of cervical lordosis, uncovertebral joint| | |
| | | | |hypertrophy, apophyseal | | |
| | | | |joint osteoarthritis, and/or diminished | | |
| | | | |vertebral canal | | |
| | | | |diameter; osteoporosis with a T score | | |
| | | | |below -2.5; medical condition that | | |
| | | | |requires long-term use of medication that| | |
| | | | |could affect bone quality and fusion | | |
| | | | |rates. | | |
|Nunley (2011) |Prospective Cohort |N = 182 |Compare the incidence of CASP at 3 |Inclusion: |TDA with Kineflex-C, |RASP: Subjects with recurrent |
| |from 3 RCTs at 2 |Male: 45% |and 4 years follow-up in 170 |One and/or two-level symptomatic cervical|Mobi-C or Advent |cervical radiculopathy/myelopathy had |
| |institutions |Mean age: 44.5 (range |patients with one- and two-level |degenerative disc disease in skeletally |Cervical Disc |MRI or CT scans that were analyzed for|
| | |22-67) |cervical degenerative disc disease |mature patients, diagnosis of |(n=120 enrolled; n=113 |evidence of degeneration at the |
| | |years |who received either TDA or ACDF in |radiculopathy or myeloradiculopathy of |at F/U) |non-operated levels**. |
| |Funding: | |three different FDA prospective, |the cervical spine in a specific nerve | |Electrophysiologic studies were then |
| |“No funding from any|F/U: 93.4% (170/182) |randomized clinical trials |root distribution C3-C7, neck and/or arm |ACDF with allograft and |performed to rule-out peripheral nerve|
| |source was received |Length of F/U: Median 38| |pain VAS at least 30 mm on 100 mm scale, |anterior plates (n=62 |pathologies. |
| |for this project.” |(range 32-54) months | |Neck Disability Index Score ≥ 30 points, |enrolled; n=57 at F/U) |CASP: CASP patients demonstrated |
| | | | |unresponsive to conservative treatment | |clinico-radiologic presence of ASP AND|
| |Study population | | |for ≥ 6 months, absence of any medical | |received active intervention |
| |overlaps with that | | |condition that would interfere with the | |(subsequent medical management or |
| |of the IDE trials; | | |proposed surgery, subject provided | |surgery) for its management |
| |separate estimate of| | |informed consent and willing to comply | | |
| |ASD frequency is not| | |with the protocol, no prior surgery at | |** RASP changes were rated as no |
| |appropriate | | |the index levels. | |disease (grade I), mild disease (grade|
| | | | | | |II), moderate disease (grade III), or |
| | | | |Exlusion: | |severe disease (grade IV). |
| | | | |Radiologic evidence of ASD, more than one| | |
| | | | |immobile vertebral level from C1-C7 from | | |
| | | | |any cause including but not limited to | | |
| | | | |congenital abnormalities and | | |
| | | | |osteoarthritic “spontaneous” fusions, | | |
| | | | |previous trauma to the C3-C7 levels | | |
| | | | |resulting in significant bony or | | |
| | | | |discoligamentous | | |
| | | | |cervical spine injury, axial neck pain in| | |
| | | | |the absence of other symptoms of | | |
| | | | |radiculopathy or | | |
| | | | |myeloradiculopathy justifying the need | | |
| | | | |for surgical intervention, radiographic | | |
| | | | |confirmation of severe facet joint | | |
| | | | |disease or degeneration, symptomatic DDD | | |
| | | | |or significant cervical spondylosis at | | |
| | | | |more than two levels, spondylolysis, | | |
| | | | |marked cervical instability on resting | | |
| | | | |lateral or flexion/extension radiographs | | |
| | | | |demonstrated by: translation greater than| | |
| | | | |3.5mm, and/or greater than 11° angular | | |
| | | | |difference to that of either adjacent | | |
| | | | |level. | | |
|Park SB (2012) |Prospective cohort |N = 33 |Evaluate the effects of cervical |Inclusion: Upper extremity |C-TDR (n=15) |RASP: Development of new spondylotic |
| | |Male: 39% |artificial disc |radiculopathy that was refractory to | |changes in the adjacent vertebral |
| |Conflict: |Mean age: ADR=45 (range |replacement (ADR) and ACDF on other|conservative treatments including |ACDF (n=18) |bodies or a decrease of more than 10% |
| |“None of the authors|17-61) years; ACDF=53 |spinal alignment using changes of |medication and physiotherapy for ≥ 6 | |in the height of adjacent discs |
| |has any potential |(range 38-66) years |sagittal balance and curves of the |week; no previous spine surgery; ≥ 2-year| |CASP: NR |
| |conflict of | |thoracic and lumbar spines |follow-up | |CASP requiring treatment: Reported |
| |interest.” |F/U: 100% (33/33) | | | |reoperation due to CASP |
| | |Length of F/U: ADR=28±5 | |Exclusion: NR | | |
| | |months; ACDF= 30±6 | | | | |
| | |months | | | | |
|Prospective cohort study comparing motion-sparing devices to motion-sparing devices |
|Ryu (2010) |Prospective Cohort |N = 46 |Determine postoperative radiologic |Inclusion: Single-level degenerative |TDA with Bryan Disc |RASP: Degenerative changes, spur |
| | |Male: 58.3% |changes in discs and facets at |cervical spine disease, underwent |(n=NR enrolled; n=19 |formation and/or progression of facet |
| |Conflict: The |Mean age: |index and adjacent levels following|cervical arhtroplasty by a single surgeon|subjects completed; n=38|arthrosis at adjacent levels on |
| |authors report no |Bryan=47.3 (range 37-62)|cervical arthroplasty using a Bryan|using a Bryan disc (1st ½ of study) or a |levels completed) |high-resolution CTs |
| |conflict of interest|yrs; |or Prodisc-C device after a minimum|Prodisc-C (2nd ½ of study). |TDA with Prodisc-C (n=NR|CASP: NR |
| |concerning the |Prodisc=45.8 (range |follow-up of 2 years; to identify | |enrolled; n=17 subjects | |
| |materials or methods|29-61) yrs |relationships between possible |Exclusion: NR |completed; n=34 levels | |
| |used in this study | |clinical factors and radiological | |completed) | |
| |or the findings |F/U: 78.3% (36/46) |changes; and to compare the results| | | |
| |specified in this |Mean F/U: 27.3±4.9 |obtained using the 2 devices | | | |
| |paper. |(range 24-40) months | | | | |
* There is a significant loss to follow-up since, at the time of publication, not all subjects had reached the 60-month follow-up.
ASP = adjacent segment pathology; RASP = radiologic adjacent segment pathology; CASP = clinical adjacent segment pathology
NR = not reported
ACDF = anterior cervical discectomy and fusion
TDA = total disc arthroplasty OR C-TDR (cervical total disc replacement)
DDD = degenerative disc disease
DEXA = dual energy x-ray absorptiometry (bone density scanning)
NDI = neck disability index
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