Table 3.
Study | Study Design | Inclusion Criteria | Exclusion Criteria | Sponsor | Definition of Adjacent Surgery | Arm | Sample Size | Technical Details | Age (mean and standard deviation unless otherwise stated) | Sex | NDI? | Reasons for adjacent surgery |
---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT00389597 50 |
RCT | Single or 2 level spondylosis with radiculopathy and/or myelopathy with levels involved C3-C7 | More than 2 levels, rigid segment, infection, osteoporosis, disc height <3mm, morbid obesity, Rheumatoid Arthritis, etc. | LDR Spine USA | Not reported | ACDF | 186 | ACDF with allograft and plate | 44.0 ± 8.2 1 level 46.2 ± 8.0 2 level |
44.4% male for 1-level, 57.1% male for 2-level | yes | Not fully reported, most common reason stated for both was “adjacent level disease or herniation” |
ADR | 389 | Mobi-C ADR | 43.3 ± 9.2 1 level 45.3 ± 8.1 2 level |
47.6% male for 1-level, 50.2% male for 2-level | yes | |||||||
NCT00437190 51,52 |
RCT | Single level degenerative disc disease with radiculopathy or myelopathy at levels between C3 and C7 | Deformity, diabetes requiring daily Insulin, morbid obesity, previous C-pine surgery, infection, steroid use. | Medtronic Spinal and Biologics | Surgery at adjacent level to index procedure | ACDF | 221 | Allograft Fusion and ATLANTIS™ Cervical Plate System | Not reported | Not reported | Yes | “Symptomatic adjacent level disease requiring surgery” |
ADR | 242 | BRYAN Cervical Disc Prosthesis | Not reported | Not reported | Yes | “Symptomatic adjacent level disease requiring surgery” | ||||||
NCT00637156 53 |
RCT | Intractable radiculopathy and/or myelopathy with degenerative disc disease at 2 adjacent cervical levels from C3-C7 | Other condition, smokers, pregnant patients, osteoporotic patients | Medtronic Spinal and Biologics | Any surgery at adjacent levels | ACDF | Historical Control from NCT00642876 5 | |||||
ADR | 209 | PRESTIGE LP device at 2 adjacent levels | 47.1 (8.3) | 44.0% male | Yes | Not reported | ||||||
NCT00642876 54 |
RCT | Single-level cervical disc disease and at least 1 additional confirmatory neuroradiographic study, such as MRI or CT-enhanced myelography that showed findings consistent with clinical findings | -Cervical spinal conditions other than single-level symptomatic degenerative disc disease or evidence of instability. -Symptomatic disc disease at level C2–3 or C7–T1, a history of discitis, or a medical condition that required medication, such as steroids or nonsteroidal anti-inflammatory medications that could interfere with fusion. |
Medtronic Spinal and Biologics | Any secondary surgery including revision at initial site that involved an adjacent level | ACDF | 265 | Allograft Fusion and ATLANTIS™ Cervical Plate System | 43.9 (22-73) | 46.0% male | Yes | Not reported |
ADR | 276 | PRESTIGE® Cervical Disc | 43.3 (25-72) | 46.4% male | Yes | Not reported | ||||||
Lee et al. 2014 55,56 | Retrospective series | Cervical spine surgery performed by the senior author (K.D.R.) for radiculopathy, myelopathy, or myeloradiculopathy between January 1999 and December 2010 | Contiguous or mixed OPLL, patients undergoing revision within 12 months. | Soonchunhyang University Research Fund (No. 20150000) | Any surgery at adjacent level | ACDF | 1038 | One level arthrodesis were performed on 353 patients; 2 levels on 374 patients; 3 levels on 228 patients; 4 levels on 70 patients; 5 levels on 12 patients; and 6 levels on 1 patient | 50 (22–89) | 49.5% male | No | New radiographically correlated symptoms at a segment adjacent to previous anterior arthrodesis minimum 1 year after the index operation |