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The Discover artificial disc replacement versus fusion in cervical radiculopathy--a randomized controlled outcome trial with 2-year follow-up.

作者信息

Skeppholm Martin, Lindgren Lars, Henriques Thomas, Vavruch Ludek, Löfgren Håkan, Olerud Claes

机构信息

Stockholm Spine Center, Löwenströmska Hospital, SE-194 89, Upplands Väsby, Sweden; Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska Universitetssjukhuset Solna (L1:00), 171 76 Stockholm, Sweden.

Stockholm Spine Center, Löwenströmska Hospital, SE-194 89, Upplands Väsby, Sweden.

出版信息

Spine J. 2015 Jun 1;15(6):1284-94. doi: 10.1016/j.spinee.2015.02.039. Epub 2015 Feb 28.


DOI:10.1016/j.spinee.2015.02.039
PMID:25733022
Abstract

BACKGROUND CONTEXT: Several previous studies comparing artificial disc replacement (ADR) and fusion have been conducted with cautiously positive results in favor of ADR. This study is not, in contrast to most previous studies, an investigational device exemption study required by the Food and Drug Administration for approval to market the product in the United States. This study was partially funded with unrestricted institutional research grants by the company marketing the artificial disc used in this study. PURPOSE: To compare outcomes between the concepts of an artificial disc to treatment with anterior cervical decompression and fusion (ACDF) and to register complications associated to the two treatments during a follow-up time of 2 years. STUDY DESIGN/SETTING: This is a randomized controlled multicenter trial, including three spine centers in Sweden. PATIENT SAMPLE: The study included patients seeking care for cervical radiculopathy who fulfilled inclusion criteria. In total, 153 patients were included. OUTCOME MEASURES: Self-assessment with Neck Disability Index (NDI) as a primary outcome variable and EQ-5D and visual analog scale as secondary outcome variables. METHODS: Patients were randomly allocated to either treatment with the Depuy Discover artificial disc or fusion with iliac crest bone graft and plating. Randomization was blinded to both patient and caregivers until time for implantation. Adverse events, complications, and revision surgery were registered as well as loss of follow-up. RESULTS: Data were available in 137 (91%) of the included and initially treated patients. Both groups improved significantly after surgery. NDI changed from 63.1 to 39.8 in an intention-to-treat analysis. No statistically significant difference between the ADR and the ACDF groups could be demonstrated with NDI values of 39.1 and 40.1, respectively. Nor in secondary outcome measures (EQ-5D and visual analog scale) could any statistically significant differences be demonstrated between the groups. Nine patients in the ADR group and three in the fusion group underwent secondary surgery because of various reasons. Two patients in each group underwent secondary surgery because of adjacent segment pathology. Complication rates were not statistically significant between groups. CONCLUSIONS: Artificial disc replacement did not result in better outcome compared to fusion measured with NDI 2 years after surgery.

摘要

相似文献

[1]
The Discover artificial disc replacement versus fusion in cervical radiculopathy--a randomized controlled outcome trial with 2-year follow-up.

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[2]
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[3]
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引用本文的文献

[1]
Complications and reoperations in young versus old patients undergoing cervical disc arthroplasty.

N Am Spine Soc J. 2025-1-21

[2]
Clinical Outcomes Following Treatment of Cervical Spondylotic Radiculopathy With Cervical Posterior Decompression Using Unilateral Biportal Endoscopic Technique: A Single Center Retrospective Series of 20 Patients.

Int J Spine Surg. 2025-3-6

[3]
Management Considerations for Cervical Corpectomy: Updated Indications and Future Directions.

Life (Basel). 2024-5-21

[4]
The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials.

Arch Orthop Trauma Surg. 2024-6

[5]
Could the different surgical goals of fusion and non-fusion also be achieved in combination within the same patient? Clinical and radiological outcome of hybrid cervical spine surgery.

Eur Spine J. 2024-6

[6]
Cervical Disc Arthroplasty: Rationale, Designs, and Results of Randomized Controlled Trials.

Int J Spine Surg. 2024-2-27

[7]
Risk Factors for Reoperation Following Single-Level Cervical Disc Arthroplasty as Utilized in a Representative Sample of United States Clinical Practice: A Retrospective PearlDiver Study.

Global Spine J. 2025-3

[8]
The Best Surgical Treatment for Cervical Radiculopathy: A Systematic Review and Network Meta-Analysis.

Adv Biomed Res. 2023-7-25

[9]
Range of motion of the mid-cervical spine: human versus goat.

J Orthop Surg Res. 2023-6-8

[10]
Comparison of discover cervical disc arthroplasty and anterior cervical discectomy and fusion for the treatment of cervical degenerative disc diseases: A meta-analysis of prospective, randomized controlled trials.

Front Surg. 2023-2-21

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