| Literature DB >> 23236310 |
Christopher K Kepler1, Erika D Brodt, Joseph R Dettori, Todd J Albert.
Abstract
STUDYEntities:
Year: 2012 PMID: 23236310 PMCID: PMC3519403 DOI: 10.1055/s-0031-1298605
Source DB: PubMed Journal: Evid Based Spine Care J ISSN: 1663-7976
Fig. 1Results of literature search.
Characteristics of included studies.*
| Author (year)/study design | CoE | Demographics | Diagnosis | Interventions | Follow-up | Funding | ||
|---|---|---|---|---|---|---|---|---|
| Studies comparing multilevel C-ADR and multilevel ACDF | ||||||||
| Cheng et al | II | C-ADR N = 31 Male %: 52 Mean age: 45 y N = 34 Male: 50% Mean age: 47 y | Spondylotic myelopathy or cervical radiculopathy due to a disc herniation or stenosis | C-ADR using the Bryan disc; all procedures performed by same surgeon | 2 y | NR | ||
| Kim et al | III | C-ADR N = 12 Male: 67% Mean age: 46.9 (30–58) y N = 28 Male: 61% Mean age: 52.7 (30–78) y | Symptomatic single- or 2-level cervical disc disease C-ADR: 83% (10/12) ACDF: 86% (24/28) C-ADR: 17% (2/10) ACDF: 14% (4/28) | C-ADR using Bryan disc | C-ADR Mean 18 (13–37) mo % Followed up NR Mean 21 (14–38) mo % Followed-up NR | NR | ||
| Coric et al | II | N = 57 | Symptomatic cervical radiculopathy or myelopathy | C-ADR | Follow-up: 2 y | Primary author is a consultant for Depuy Spine and Spinal Motion | ||
| Goffin et al | III | N = 98 Male: 42.7% Mean age (± SD): 43.2 ± 9.0 y Male: 77.8% Mean age (± SD): 49.3 ± 7.2 y | Radiculopathy due to: Single level: 56.2% Multilevel: 0% Single level: 20.2% Multilevel: 88.9% Single level: 15.7% Multilevel: 0% Single level: 5.6% Multilevel: 0% Single level: 2.2% Multilevel: 11.1 | C-ADR with Bryan disc | Follow-up: 4–6 y 4 y: 100% 6 y: 60.2% (59/98) | Research support and editorial assistance for this study was received from Medtronic Sofamor Danek. | ||
| Huppert et al | III | N = 231 Male: 40.0% Mean age (range): 43.8 (23–63) y Male: 39.3% Mean age (range): 48.2 - (34–65) y | DDD causing radiculopathy and/or myelopathy | Mobi-C C-ADR 2-level, n = 51; 3-level, n = 4; 4-level, n = 1 | Single level: Mean 2.0 (1.4–2.5) y % Followed-up NR | NR | ||
| Kim et al | III | N = 52 | Herniated disc: 44.2% | Bryan C-ADR interbody fusion (13.5%); anterior microforaminotomy (15.4%) | Follow-up: mean 2.4 (1.5–3) y | NR | ||
| Kim et al | III | N = 51 Male: 66.7% Mean age (range): 46.9 (30–58) y | Radiculopathy | Bryan C-ADR | Follow-up: mean 1.5 (1.1–3.3) y | NR | ||
| Pimenta et al | II | N = 140 Male: 39.4% Mean age (range): 45.5 (28–77) y Male: 40.6% Mean age (range): 46.6 (29–80) y | HNP Single level: 32.4% Multilevel: 42.0% Single level: 67.6% Multilevel: 58.0% Single level: 73.2% Multilevel: 66.7% Single level: 26.8% Multilevel: 33.3% | C-ADR using the PCM Porous Coated Motion Device Intervertebral Dynamic Disc Spacer 2-level, n = 53 3-level, n = 12 4-level, n = 4 | Follow-up: mean 2.2 (1–3.5) y | Corporate/ industry and foundation funds were received in support of this work. | ||
| Tu et al | III | N = 36 | Disc herniation: 61.1% | C-ADR using Bryan | Follow-up: mean 1.6 (range, 1–2.3) y | This study was supported by grant VGH 99-S6-001 from Taipei Veterans General Hospital. | ||
C-ADR indicates cervical artificial disc replacement; ACDF, anterior cervical discectomy and fusion; FSU, functional spinal unit; CoE, level of evidence; NR, not reported; RCT, randomized control trial; DDD, degenerative disc disease; OPLL, ossification of the posterior longitudinal ligament; HNP, herniated nucleus pulposis.
The study reported comparisons between both single-level and multilevel C-ADR and ACDF. Only 2-level cases are reported for the purpose of this article.
This study compared pooled groups of patients from three RCTs who underwent C-ADR vs ACDF (N = 98). Only the C-ADR group is reported here. Demographics are after loss to follow-up (n = 53).
Long-term follow-up results from Goffin et al3. The 98 patients included in this study agreed to participate in follow-up studies for up to 10 years; the original study had a total of 146 patients enrolled.
A total of 384 patients were enrolled in this study; a total of 231 (60.2%) have completed their 2-month follow-up evaluation and were included in the analysis.
Only the comparison between single-level and multilevel C-ADR is reported.
Function and neck pain following multi-level C-ADR and multilevel ACDF.*
| NDI Mean score (% change from preop) | VAS neck painMean score (% change from preop) | |||||
|---|---|---|---|---|---|---|
| C-ADR | ACDF | C-ADR | ACDF | |||
| Cheng et al | 50 | 51 | NS | 7.3 | 7.1 | NS |
| Kim et al | 26.4 | 26.2 | NS | 8.8 | 8.1 | NR |
| Cheng et al | 12 (76.0) | 18 (64.7) | .03 | 1.9 (74.0) | 2.5 (64.8) | NR |
| Cheng et al | 11 (78.0) | 19 (62.7) | .02 | 1.5 (79.5) | 2.6 (63.4) | .01 |
| Kim et al | 7.8 (70.5) | 8.0 (69.5) | NS | 3.3 (62.5) | 3.4 (58.0) | NS |
C-ADR indicates cervical artificial disc replacement; ACDF, anterior cervical discectomy and fusion; NDI, Neck Disability Index; VAS, Visual Analog Scale; preop, preoperative; NR, not reported; and NS, not statistically significant.
Function and neck pain following single-level and multilevel C-ADR.*
| NDI Mean score (% change from preop) | VAS neck pain Mean score (% change from preop) | |||||
|---|---|---|---|---|---|---|
| Single | Multi | Single | Multi | |||
| Huppert et al | 51.5 | 51.4 | NS | 5.3 | 5.1 | NS |
| Kim et al | 25.3 | 26.4 | NS | 8.3 | 8.8 | NS |
| Pimenta et al | 48 | 44 | NS | 8.6 | 8.5 | NS |
| Huppert et al | 25.5 (50.5) | 30.0 (41.6) | NR | 2.1 (60.4) | 2.2 (56.8) | NR |
| Kim et al | 7.6 (69.9) | 7.8 (70.5) | NS | 3.7 (55.4) | 3.3 (62.5) | NS |
| Pimenta et al | 27 (43.8) | 20 (54.5) | NR | 3.3 (61.6) | 3.0 (64.7) | NR |
| Huppert et al | 27.3 (47.0) | 29.2 (43.2) | NS | 2.4 (54.7) | 2.4 (52.9) | NS |
| Pimenta et al | 26 (45.8) | 22 (50.0) | NR | 3.0 (70.0) | 2.7 (68.2) | NR |
| Pimenta et al | 21 (56.3) | 11 (75.0) | NR | 4.0 (53.5) | 1.5 (82.4) | NR |
C-ADR indicates cervical artificial disc replacement; NDI, Neck Disability Index; VAS, Visual Analog Scale; preop, preoperative; NR, not reported; and NS, not statistically significant.
Pain scores from Huppert et al 5 were normalized from a VAS 100 mm scale to a VAS 10 mm scale for comparison purposes.
Health-related quality of life following single-level and multilevel C-ADR.*
| Study/follow-up | SF-36 PCS Mean score (% change from preop) | SF-36 MCS Mean score (% change from preop) | ||||
|---|---|---|---|---|---|---|
| Single | Multi | Single | Multi | |||
| Goffin et al | 36.1 | 37.4 | NS | 40.1 | 35.5 | NS |
| Huppert et al | 36.6 | 36.6 | NS | 35.3 | 34.3 | NS |
| Goffin et al | 46.9 (29.9) | 47.0 (25.7) | NR | 50.0 (24.7) | 46.1 (29.9) | NR |
| Huppert et al | 47.2 (29.0) | 45.7 (24.9) | NR | 45.9 (30.0) | 44.0 (28.3) | NR |
| Goffin et al | 45 (24.7) | 49 (31.0) | NR | 51 (27.2) | 53 (49.3) | NR |
| Huppert et al | 46.7 (27.6) | 43.9 (19.9) | NS | 46.0 (30.3) | 45.6 (32.9) | NS |
| Goffin et al | 47 (30.2) | 52 (39.0) | NR | 52 (29.7) | 52 (46.5) | NR |
| Goffin et al | 47 (30.2) | 51 (36.4) | NR | 52 (29.7) | 47 (32.4) | NR |
C-ADR indicates cervical artificial disc replacement; SF-36, Short-Form 36; PCS, Physical Component Score; MCS, Mental Component Score; preop, preoperative; NS, not statistically significant; and NR, not reported.
Preoperative and 1 year scores were taken from Goffin et al3 which reported short-term follow-up outcomes for the same population.
Means estimated from figures provided in the article.
Complications and adverse events following single-level and multilevel C-ADR.*
| Single level, % (n/N) | Multilevel, % (n/N) | Follow-up, y | ||
|---|---|---|---|---|
| Coric et al | 5.0 (2/40) | 16.7 (2/12) | NR | 2 |
| Huppert et al | 2.3 (4/175) | 3.6 (2/56) | NS | 2 |
| Pimenta et al | 4.2 (3/71) | 2.9 (2/69) | NS | NR |
| Huppert et al | 0.6 (1/175) | 0 (0/56) | NS | 2 |
| Heterotopic ossification | ||||
| Huppert et al | 66.7 (110/165) | 55.0 (61/111) | .02 | 2 |
| Tu et al | 30.0 (6/20) | 75.0 (12/16) | .007 | 1 |
| Coric et al | 0 (40) | 8.3 (1/12) | NR | 2 |
| Huppert et al | 10.3 (17/165) | 7.2 (8/111) | NS | 2 |
| Pimenta et al | 1.4 (1/71) | 0 (0/69) | NR | NR |
| Huppert et al | 4.0 (7/175) | 16.1 (9/56) | .002 | 2 |
| Huppert et al | 1.1 (2/175) | 0 (5/56) | NS | 2 |
| Huppert et al | 0.6 (1/175) | 1.8 (1/56) | NS | 2 |
| Pimenta et al | 0 (0/71) | 0 (0/69) | – | NR |
| Pimenta et al | 0 (0/71) | 0 (0/69) | – | NR |
| Goffin et al | 66.3 (61/92) | 40.0 (4/10) | NR | 6 |
Incidences reflect the number of patients with one or more adverse event/complication. C-ADR indicates cervical artificial disc replacement; NR, not reported; and NS, not significant.
Approximately 60% of all reported adverse events occurred 2 years after index surgery and about 15% of these events were continuations of earlier reports.
Fig. 2Midline sagittal T2 MRI image demonstrates evidence of disc herniation at C4–5 and C6–7 while the other motion segments appear relatively well-preserved.
Fig. 3Axial T2 MRI image at C4–5 demonstrates right-sided neuroforaminal stenosis secondary to disc herniation.
Fig. 4Axial T2 MRI image at C6–7 demonstrates bilateral neuroforaminal stenosis secondary to disc protrusion.
Fig. 5Anteroposterior postoperative x-ray demonstrates C4–5 and C6–7 disc replacements which are well-placed in midline.
Fig. 6Neutral lateral postoperative x-ray demonstrates C4–5 and C6–7 disc replacements.
Multilevel C-ADR versus multilevel ACDF
| Pain and disability | ||
|---|---|---|
| 1. Overall success | Odom’s criteria reported by one RCT at 2 years with excellent or good results seen in a greater proportion of multilevel C-ADR patients compared with multilevel ACDF patients. | |
| 2. VAS | Greater improvement in neck pain from baseline to 1 and 2 years reported by two studies following multilevel C-ADR versus multilevel ACDF; however, only one reported that the differences were statistically significant. | |
| –Arm pain | Slightly greater improvement in arm pain at 1 year after multilevel C-ADR compared with multilevel ACDF in one study. | |
| 3. NDI | Greater improvement from baseline to 1 and 2 years follow-up following multilevel C-ADR versus multilevel ACDF reported by two studies; however, only one reported that the differences were statistically significant. | |
| 4. Quality of Life | The C-ADR group showed a statistically greater percentage improvement at 1 and 2 years over baseline compared with the ACDF group as reported by one RCT. | |
Single-level versus multilevel C-ADR
| Pain and disability | ||
|---|---|---|
| 1. Overall success | Three studies reported various measures of overall success (Odom’s criteria, neurological success, composite measure) and found no statistical differences between treatment groups across 1 to 6 years of follow-up. | |
| 1. Pain | Measured a variety of ways (VAS, analgesic use, treatment intensity score) across four studies. | |
| 3. NDI | No significant differences between single-level and multilevel C-ADR in NDI scores over 1 to 6 years follow-up as reported by four studies. | |
| 4. Quality of Life | No significant differences were reported between single-level and multilevel C-ADR at 1, 2, 4, or 6 years follow-up in two studies. | |
| 5. Patient satisfaction | Similar numbers of patients in both treatment groups were satisfied with their treatment and would repeat the procedure as reported by one study. | |
| 6. Return to work | Greater proportion of multilevel C-ADR patients returned to part-time or full-time work and at a quicker rate than single-level C-ADR patients in one study. | |