Clinical Outcomes of a Zero Profile Implant for Single-Level Anterior Cervical Discectomy and Fusion

Dae Ho Ha; Sung Kyun Oh; Dae Moo Shim

doi:10.4184/jkss.2016.23.2.71

Journal List > J Korean Soc Spine Surg > v.23(2) > 1076122

Go to TopGo to Top Go to BottomGo to Bottom

TOOLS

Ha, Oh, and Shim: Clinical Outcomes of a Zero Profile Implant for Single-Level Anterior Cervical Discectomy and Fusion

Original Article

Journal of Korean Spine Surg 2016;23(2):71-76.

Published online: 30 June 2016

DOI: https://doi.org/10.4184/jkss.2016.23.2.71

Clinical Outcomes of a Zero Profile Implant for Single-Level Anterior Cervical Discectomy and Fusion

Dae Ho Ha, M.D., Sung Kyun Oh, M.D., Dae Moo Shim, M.D.^∗

Department of Orthopedic Surgery, School of Medicine, Wonkwang University Sanbon Hospital, GunPo, Korea

^∗Department of Orthopedic Surgery, School of Medicine, Wonkwaning University, Iksan, Korea

Corresponding author: Sung Kyun Oh, M.D. Department of Orthopedic Surgery, School of Medicine, Wonkwang University Sanbon Hospital, Sanbondong, Gunpo City, Gyeongido, Korea TEL: +82-31-390-2992, FAX: +82-31-390-2244 E-mail: niceo@hanmail.net

^∗ This paper was supported by Wonkwang University in 2016.

Received 5 August 201511 August 2015 Accepted 14 December 2015

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Study Design

A retrospective study.

Objectives

To evaluate and compare the clinical results of a zero profile implant with a conventional standalone cage.

Summary of Literature Review

A new zero-profile interbody fusion implant named Zero-P was developed in order to avoid plate-related complications.

Materials and Methods

Twenty-three patients with cervical degenerative disc disease were enrolled. Twelve of these were implanted with a standalone cage, and 11 patients received a Zero-P. The mean follow-up time was 16.7 months, ranging from 12 to 34 months. Intraoperative parameters, clinical outcomes (Korean Neck Pain Disability Index [K-NDI], visual analog scale [VAS] score for neck/arm pain), dysphagia scores, and device-related complications were recorded.

Results

At the 6-week, 3-month, 6-month, and 12-month follow up, the K-NDI and VAS scores significantly improved in both groups. Dysphagia scores in both groups have no significant differences (p>0.05). However, the cage subsidence rate was significantly higher in the standalone cage group (p<0.05).

Conclusions

Clinical outcomes of ACDF with the Zero-P were satisfactory. The incidence of cage subsidence was lower than with the conventional standalone cage.

Keywords: Cervical radiculopathy, Anterior cervical fusion

REFERENCES

1. Song KJ, Taghavi CE, Lee KB, et al. The efficacy of plate construct augmentation versus cage alone in anterior cervical fusion. Spine (Phila Pa 1976). 2009; 34:2886–92.

2. Lee CH, Hyun SJ, Kim MJ, et al. Comparative analysis of 3 different construct systems for single-level anterior cervical discectomy and fusion: standalone cage, iliac graft plus plate augmentation, and cage plus plating. J Spinal Disord Tech. 2013; 26:112–8.

3. Scholz M, Schnake KJ, Pingel A, et al. A New Zero-profile Implant for Stand-alone Anterior Cervical Interbody Fusion. Clin Orthop Relat Res. 2011; 469:666–73.

4. Chen Y, Chen H, Cao P, et al. Anterior cervical interbody fusion with the Zero-P spacer: mid-term results of two-level fusion. Eur Spine J. 2015; 24:1666–72.

5. Miao J, Shen Y, Kuang Y, et al. Early follow-up outcomes of a new zero-profile implant used in anterior cervical discectomy and fusion. J Spinal Disord Tech. 2013; 26:E193–7.

6. Azab W, Abdel-Razek M, Ali A, et al. Outcome evaluation of a zero-profile implant for anterior cervical diskectomy with fusion. Turk Neurosurg. 2012; 22:611–7.

7. Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002; 27:2453–8.

8. Cannada LK, Scherping SC, Yoo JU, et al. Pseudoarthrosis of the cervical spine: a comparison of radiographic diagnostic measures. Spine(Phila Pa 1976). 2003; 28:46–51.

9. Park JI, Cho DC, Kim KT, et al. Anterior Cervical Discectomy and Fusion Using a Stand-Alone Polyetheretherk-etone Cage Packed with Local Autobone: Assessment of Bone Fusion and Subsidence. J Korean Neurosurg Soc. 2013; 54:189–93.

10. Vanek P, Bradac O, Delacy P, et al. Anterior interbody fusion of the cervical spine with Zero-P spacer: prospective comparative study-clinical and radiological results at a minimum 2 years after surgery. Spine (Phila Pa 1976). 2013; 38:E792–7.

11. Park JB, Cho YS, Riew KD. Development of adjacent-level ossification in patients with an anterior cervical plate. J Bone Joint Surg Am. 2005; 87:558–63.

12. Kim YM, Oh KW, Kim DS, et al. Subsidence of Poly-etheretherketone Cage after Anterior Cervical Fusion. J Ko-rean Orthop Assoc. 2014; 49:185–93.

13. Karikari IO, Jain D, Owens TR, et al. Impact of subsidence on clinical outcomes and radiographic fusion rates in anterior cervical discectomy and fusion: a systematic review. J Spinal Disord Tech. 2014; 27:1–10.

14. Yang H, Chen D, Wang X, et al. Zero-profile integrated plate and spacer device reduces rate of adjacent-level ossification development and dysphagia compared to ACDF with plating and cage system. Arch Orthop Trauma Surg. 2015; 135:781–7.

Fig. 1.

Cage subsidence was measured as the distance from the midpoint of the endplate to the midlower margin of the cage.

Table 1.

Patients demographic data

	Zero-P	Cage alone	X2
Male/Female	8/3	8/4	p> 0.1
Mean age	57.2(49–73)	58.9(46–81)	p=0.71^∗
Osteoporosis	0	0	p>0.1
Level C3-4	1	2	p>0.1
C4-5	2	2	p>0.1
C5-6	4	5	p>0.1
C6-7	4	3	p>0.1
Total	11	12

^∗ : Man Whitney test.

Table 2.

Dysphagia score

Severity	Liquid	Solid
0 None	None	None
1 Mild	None	Rare
2 Moderate	None or rare	Occasionally with specific food
3 Severe	None or rare	Frequent(Majority of solids)

Table 3.

Clinical outcomes, visual analogue scale of neck pain clinical outcomes Zero-P vs cage alone VAS score, neck pain

	Initial	Last F/U	Wilcoxon singed rank test
Zero-P	5.90±1.3	1.54±1.2	p=0.002
Cage alone	6.41±1.2	1.91±1.2	p=0.003
Mann-W U test	p=0.395	p=0.505

Table 4.

Clinical outcomes, visual analogue scale of arm pain clinical outcomes Zero-P vs cage alone VAS score, arm pain

	Initial	Last F/U	Wilcoxon singed rank test
Zero-P	6.81±1.16	1.18±1.32	p=0.003
Cage alone	7.25±1.30	1.16±1.19	p=0.002
Man-W U test	p=0.468	p=0.974

Table 5.

NDI Zero-P vs cage alone

Table 6.

Dysphagia: Zero-P vs cage alone

	Zero-P	Cage alone
2 week	Moderate 27% Severe 9%	Moderate 33% Severe 8%
6 week	Mild 9%	Mild 8%
3 month	None	None

Moderate, Severe Dysphagia, p=0.405 Fisher exact test.

Table 7

Cobb C angle

	Pre operative	Last F/U	p-value
Zero-P	13.9°±10.3	15.6°±9.7	0.306
Cage alone	17.9°±7.3	21.7°±10.5	0.080

Cervical Cobb angle increased in both group.

Table 8.

Cage subsidence

	post op 2 week	Last F/U
Zero-P	0.74 mm±0.55	1.32 mm±0.52
Cage Alone	1.43 mm±0.60	2.30 mm±0.79
p–value	0.059	0.046

TOOLS

Similar articles