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Study | Study design and device | No. of patients initially treated with CDA | Revisions surgeries at index level, at any other level or nonspecified | Procedure for revision the index level failure | Complications | Observations |
---|---|---|---|---|---|---|
Walraevens et al. [8], 2010 | Prospective cohort study single center | 89 Patients | 4-Year follow-up – 2 reoperated at an adjacent level (excluded) | Heterotopic ossification at: 4 years – 66% HO free and 5% grade 4, 6 years – 62% HO free and 8% grade 4, 8 years – 61% HO free and 8% grade 4 | ||
Bryan | 4- to 6-year follow up – 1 reoperated at the index level and 2 at an adjacent level (3 excluded) | |||||
1 Patient operated at the index level | Subsidence: 0.69±4.5 mm at 4 years; 0.72±0.59 mm at 6 years and 0.77±0.69 mm at 8 years | |||||
4 Operated on at an adjacent level | ||||||
Aghayev et al. [9], 2013 | Prospective multicenter observational case series | 332 Patients | Intraoperative complication 0.6%. Two patients (0.6%) required early surgery for implant removal and fusion and hematoma evaluation. | 2 ACDF | 37 (11%) Had ASD progression – 35 had one segment treated and 2 had 2 segments treated | At 5 years of follow-up 40.7% had osteophytes affecting range of motion |
Bryan | ||||||
Prestige | ||||||
Discocerv | 12 (3.6%) Patients had early reintervention not specified. | 15 Patients (4.6%) had a progression of distant segment degeneration – 14 with a monosegmental surgery and 1 with a bisegmental surgery – 7 were cranially and 9 caudally to the treated level | ||||
Scient’x | ||||||
Moby-C | Early postoperative complication 7.2% | |||||
LDR Medical | ||||||
ProDisc-C | ||||||
Hacker et al. [10], 2013 | Prospective single site randomized clinical trial | 28 Patients (Bryan)+4 additional patients | 5 Patients had symptoms attributed to the CDA – 4 Bryan (2 patients beyond 4 years of follow-up and 2 beyond 5 years) and 1 Prestige (after 4 years of follow-up). |
3 ACDF 1 ACCF 1 PCF |
2 Other Bryan with neck pain treated without surgery – haloing about their devices – 1 case 1 year later with resolution of the haloing and improvement and the other lost follow-up. | |
Bryan | 19 Patients (Prestige LP) | 2 Bryan – surgical revision – 1 for device subluxation and subtle findings of myelopathy than an ACDF was performed – outcome was fair. 1 for kyphosis and bone deformity requiring a two level ACDF with a good outcome. | ||||
Prestige LP | 1 Prestige case had neck and arm pain with loss of vertebral body height and deformity, with HO. | |||||
Device was removed with a 2 level fusion and minimal improvement. After that a third procedure was required for graft subsided, with kyphosis, corpectomy then posterior fusion – a fair outcome was reported. | ||||||
Zigler et al. [11], 2013 | Prospective randomized multicenter study | 103 Patients | 2.9% of secondary surgeries at 5 years (3 at the index level due to ongoing pain without implant failures) | Implanted related adverse effects reported for 1% | ||
ProDisc-C | 11.7% of surgery-related adverse events (dysphagia, edema, dural tear, etc.) | |||||
Burkus et al. [12], 2014 | Prospective randomized multicenter study | 276 Patients | 11 Patients (4.8%) had secondary surgeries at the index level. | 8 ACDF | Subsidence 12/165 patients at 60 months and 7 (4.2%) of 166 patients at 84 months | |
Prestige | No revision surgery for adjust or modify the original implant configuration | 1 Patient had disc implant migration (0.5%) at the 84-month evaluation. | ||||
8 Nonelective implant removals with an interbody fusion because of persistent radicular pain | 5 Patients (2.4%) had a broken or fractured Prestige screw | |||||
11 Patients (4.6%) had a second surgery involved adjacent levels. | ||||||
Janssen et al. [13], 2015 | Prospective randomized multicenter study | 103 Initially but 86 patients were followed | 7 Secondary surgeries – 7%, 6 at the index level – 5 with device removal and fusion and 1 involved a foraminotomy and posterior cervical fusion with the ProDisc left in place. | 5 ACDF | 41 Adverse events in 28 (27%) of the 103 patients – neck pain that was the most common | |
ProDisc-C | 1 PCF+ foraminotomy | |||||
Gornet et al. [14], 2016 | Prospective nonrandomized multicenter study | 280 Patients | Cumulative rate of secondary surgery was 9.6% at the index and adjacent level. | 14 ACDF | 17.5% of adverse effects related to device and surgical device surgical procedure related events, with 6.1% of serious adverse effects secondary to device | 13% of HO at 84 months |
Prestige LP | There were 23 additional procedures: 1 revision, 14 removal, 4 supplemental fixation and 3 reoperations. | 4 Revision/reoperations | ||||
2-levels | 4 Supplemental fixation | |||||
Hisey et al. [15], 2016 | Prospective randomized multicenter study | 164 Patients | 8 Patients (4.9%) had a subsequent surgery | 1 Laminectomy | Radiographic failure (defined as spontaneous fusion with radiographic evidence of bridging bone across the disc space and less than 2° of angular motion on flexion/extension) occurred in 5.5% of the patients | Reasons for fusion at the index level: oversized implant, development of heterotopic ossification causing pain and kyphosis due to malpositioned device |
Mobi-C | 1 Patient had a laminectomy at the index level, 4 cases had a fusion and removal of the implant (2 of these 4 had also a third surgery to revise the ACDF). Finally, 3 patients (1.83%) had surgery at the adjacent level. | 4 ACDF | ||||
Jackson et al. [16], 2016 | Prospective randomized multicenter clinical trial | 260 Patients 1 level | 4.5% Subsequent surgery for 1-level | 2 ACDF | Some patients required multiple subsequent surgeries: 1 had a TDR removed than an ACDF at the index level, and finally a three level fusion. | |
Mobi-C | 234 patients 2 levels | 7.3% Subsequent surgery for 2-level | 1 ACDF + posterior fusion | 1 Had a TDR removed then 2 level fusion and finally a revision fusion with foraminal decompression | ||
One or 2 levels | 3.4% (6/179) Revision at the index level 1-level group | 1 Patient had removal of the 2 TDR with a fusion, requiring an anterior fusion followed by a combined fusion later | ||||
4.7% (11/234) Revision at the index level 2-level group | 1 Patient had a TDR removed after a motor vehicle accident | |||||
Radcliff et al. [17], 2016 | Prospective randomized multicenter study | 225 Patients | 16 Secondary surgeries (7.1%, 16/225) – 9/225 (4%) in the index level and 7/225 (3.1%) at adjacent levels | 10 Patients (4.4%) had potentially devicerelated serious adverse events – with 4 cases of implant malposition | ||
Mobi-C | ||||||
Dejaegher et al. [18], 2017 | Prospective cohort study single center | 89 Patients | 7 Patients (8%) had 8 additional spine surgery to treat persistent symptoms – 6 radiculopathy and 1 myelopathy – 2 (2%) at the index level and 5 (6%) at an adjacent levels | 21 Patients (24%) had new or recurrent radiculopathy or myelopathy | ||
Bryan | 14 Patients treated non-surgically for pain – 12 solved and 2 were symptomatic but did not have a new procedure | 186 Adverse effects during follow-up in 73 patients – 34% pain problems (neck, shoulder or arm), 25% pain in the hip, leg, knee or low back. | ||||
2nd surgery at the index level – 2 patients had their prosthesis removed. | ||||||
Adjacent level surgery – 3 patients had a 2nd Bryan implanted, one of them receiving a later laminoforaminotomy later. | ||||||
2 Patients had a fusion due to bridging osteophytosis and kyphosis. | ||||||
Lanman et al. [19], 2017 | Prospective randomized multicenter study | 209 Patients | 4.2% of secondary surgeries at the index level (8 patients 10 surgeries) – one removal after 40 days postoperatively due to arm pain and the other at 1.3 years due to cervical kyphosis. Other removals between 1.7 to 4.5 years due to foraminal stenosis, degenerative changes (2 cases), failed arthroplasty and loosening of hardware after a motor vehicle accident | 8 ACDF | 3.2% of serious adverse effects (grade 3 or 4) – implant or surgical procedure associated | |
Prestige LP 2-levels | 6.5% of second surgeries at adjacent levels | 11.9% of grade IV HO | ||||
Mehren et al. [20], 2017 | Prospective cohort study | 50 Patients 27 (57.4%) 1 level; 17 (36.2%) 2 levels, and 3 (6.4%) with 3 levels | No surgery for symptomatic adjacent level | 2 ACDF | No prosthesis dislocations | HO at 10 years: grade 0, 10%; grade 1, 10%; grade 2, 22%; grade 3, 32%, and grade 4, 26% |
ProDisc C | Three patients underwent spine infiltrations for neck pain. | One case – significant subsidence after a motor vehicle accident (non-operative management) | ||||
Two patients required a fusion due to intraoperative fractures of the posterior vertebral wall and 1 patient was reoperated one year after surgery due to neck pain. | 13 (35.7%) of adjacent segment degeneration (10 cranial and 3 below the index level) | |||||
Radcliff et al. [21], 2017 | Prospective randomized multicenter study | 164 Patients (1 level) | 1 Level: subsequent surgeries at the index level was 3% (5/164 – 4 removal, 1 reoperation) for persistent radiculopathy and neck pain (3) | 9 ACDF | 5.3% (12/225) of patients had adverse events for 2-level and 6.1% (10/164) for one level. | A bridging bone at either level was presented in 11.1% (12/108) of patients for 1-level |
Mobi-C | 225 Patients (2 levels) | 1 Malpositioned implant required additional surgery | 5 Reoperation | A bridging bone at either level was presented in 11.1% of patients for 2 levels | ||
1 Gross motion due to over distraction and oversized implant requiring a fusion | 1 Supplemental fixation | 1 Level: 40.4% of ASD in the superior level and 43.8% in the inferior level | ||||
3.7% (6/164) Required surgery for at least one adjacent level | 2 Levels: 37.5% of ASD in the superior level and 30.3% in the inferior level | |||||
2 Levels: subsequent surgeries at the index level was 4.4% (10/225 – 5 removal, 2 reoperation, 2 revision, and 1 supplemental fixation) for persistent radiculopathy and neck pain (7), and 4.4% (10/225) at the adjacent level. | ||||||
Sasso et al. [22], 2017 | Prospective randomized singlecenter study | 22 Patients | 9% (2 patients) Required reoperation – one at an adjacent level and a second at a nonadjacent level (ACDF used for both) | 2 ACDF | No details of complications | Three patient were converted intraoperatively to an ACDF – severe disc degeneration, small disc space and inadequate visualization of the index level (C67) |
Bryan | ||||||
Coric et al. [23], 2018 | Prospective randomized multicenter study | 136 Patients | 8% of revision surgeries at the index level (11 patients) | 1.4% Device migration | No details of outcome after reoperations or details of the technique used for reoperation | |
MoM TDR | 7 Patients (5.1%) – device related | 1.4% Subsidence | ||||
Kineflex C | 4 Patients (3%) probably device related | 14.3% of radiolucency | ||||
HO with a bridging across the disc space in 2.9% of the cases | ||||||
Vaccaro et al. [24], 2018 | Prospective nonrandomized and randomized multicenter study | 89 Patients nonrandomized and 151 randomized patients | 10 Surgeries at the index level (4.2%) at 7 years postoperative – 6 removals and 4 posterior decompressions without removal of the device | 6 ACDF | 62.3% of patients had symptoms possibly related to adjacent level | |
Secure-C | 10 Surgeries at adjacent levels (4.2%) | 4 Posterior decompression | ||||
Lavelle et al. [25], 2019 | Prospective randomized singlecenter study | 242 Patients | Serious adverse effects 4.1% - 8 cases - 1 reported implant loosening, 1 mal-positioned implant, 1 excessive neck/ arm pain, and 5 spinal events (all the 8 at the index level with three requiring implant removal) | 3 ACDF | ||
Bryan | ||||||
Gornet et al. [26], 2019 | Prospective randomized multicenter study | 209 Patients | Cumulative rate of secondary surgery was 4.7% (9 patients) at the index level (six removal, 2 supplemental fixation and 3 reoperation) and 9% at adjacent levels | 6 ACDF | Cumulative rate of serious adverse effects (grade 3 and 4) associated with implant were 3.8% patients through 10 years | |
Prestige LP | 2 Supplemental fixation | |||||
2-levels | 3 Reoperation | Rate of HO grade III and IV 39% | ||||
Dufour et al. [27], 2019 | Prospective cohort multicenter study | 384 Patients with 535 prostheses | 1.5% of reoperation at the index level – 6 of 384 – device removal or repositioning. | Complication rates: 34 patients (8.9%) had 41 adverse events (device-surgery related with/ without reoperation) | Grade 4 HO - 16.4% of the implanted segments had ossification with complete fusion; grade 3 in 6.8%, grade 2 in 39.4%, grade 1 in 14.4%, and grade 0 in 22.9%. | |
Mobi-C | 2.9% of surgery at adjacent levels – 11 patients – 4 for new symptomatic ALD and 7 had already an ADD minor before surgery | Distal and proximal adjacent degeneration occurred in 42.2% and 39.1% of patients. |