Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2010

Open Access 01-12-2010 | Study protocol

The NEtherlands Cervical Kinematics (NECK) Trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study

Authors: Mark P Arts, Ronald Brand, Elske van den Akker, Bart W Koes, Wilco C Peul

Published in: BMC Musculoskeletal Disorders | Issue 1/2010

Login to get access

Abstract

Background

Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation.

Methods/Design

Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only, anterior discectomy with interbody fusion, and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index, perceived recovery, arm and neck pain, complications, re-operations, quality of life, job satisfaction, anxiety and depression assessment, medical consumption, absenteeism, and costs. The study is a randomised prospective multicenter trial, in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years.

Discussion

Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prothesis is necessary and cost-effective will be determined by this trial.

Trial Registration

Netherlands Trial Register NTR1289
Literature
1.
Cloward RB: The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958, 15: 602-617. 10.3171/jns.1958.15.6.0602.CrossRefPubMed
2.
Hirsch C: Cervical disc rupture: diagnosis and therapy. Acta Orthop Scand. 1960, 30: 172-186.CrossRef
3.
Abd-Alrahman N, Dokmak AS, Abou-Madawi A: Anterior cervical discectomy (ACD) versus anterior cervical fusion (ACF), clinical and radiological outcome study. Acta Neurochir (Wien). 1999, 141: 1089-1092. 10.1007/s007010050487.CrossRef
4.
Dowd GC, Wirth FP: Anterior cervical discectomy: is fusion necessary?. J Neurosurg. 1999, 90: 8-12.PubMed
5.
Barlocher CB, Barth A, Krauss JK, Binggeli R, Seiler RW: Comparative evaluation of microdiscectomy only, autograft fusion, polymethylmethacrylate interposition, and threaded titanium cage fusion for treatment of single-level cervical disc disease: a prospective randomized study in 125 patients. Neurosurg Focus. 2002, 12: E4-10.3171/foc.2002.12.1.5.CrossRefPubMed
6.
Martins AN: Anterior cervical discectomy with and without interbody bone graft. J Neurosurg. 1976, 44: 290-295. 10.3171/jns.1976.44.3.0290.CrossRefPubMed
7.
Rosenorn J, Hansen EB, Rosenorn MA: Anterior cervical discectomy with and without fusion. A prospective study. J Neurosurg. 1983, 59: 252-255. 10.3171/jns.1983.59.2.0252.CrossRefPubMed
8.
Savolainen S, Rinne J, Hernesniemi J: A prospective randomized study of anterior single-level cervical disc operations with long-term follow-up: surgical fusion is unnecessary. Neurosurgery. 1998, 43: 51-55. 10.1097/00006123-199807000-00032.CrossRefPubMed
9.
van den Bent MJ, Oosting J, Wouda EJ, van Acker EH, Ansink BJ, Braakman R: Anterior cervical discectomy with or without fusion with acrylate. A randomized trial. Spine. 1996, 21: 834-839. 10.1097/00007632-199604010-00011. discussion 840CrossRefPubMed
10.
Jacobs WC, Anderson PG, Limbeek J, Willems PC, Pavlov P: Single or double-level anterior interbody fusion techniques for cervical degenerative disc disease. Cochrane Database Syst Rev. 2004, CD004958-
11.
Hilibrand AS, Carlson GD, Palumbo MA, Jones PK, Bohlman HH: Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am. 1999, 81: 519-528.PubMed
12.
Coric D, Finger F, Boltes P: Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site. J Neurosurg Spine. 2006, 4: 31-35. 10.3171/spi.2006.4.1.31.CrossRefPubMed
13.
Hacker RJ: Cervical disc arthroplasty: a controlled randomized prospective study with intermediate follow-up results. Invited submission from the joint section meeting on disorders of the spine and peripheral nerves, March 2005. J Neurosurg Spine. 2005, 3: 424-428. 10.3171/spi.2005.3.6.0424.CrossRefPubMed
14.
Goffin J, Casey A, Kehr P, Liebig K, Lind B, Logroscino C, Pointillart V, Van Calenbergh F, van Loon J: Preliminary clinical experience with the Bryan Cervical Disc Prosthesis. Neurosurgery. 2002, 51: 840-845. 10.1097/00006123-200209000-00048. discussion 845-847PubMed
15.
Lafuente J, Casey AT, Petzold A, Brew S: The Bryan cervical disc prosthesis as an alternative to arthrodesis in the treatment of cervical spondylosis: 46 consecutive cases. J Bone Joint Surg Br. 2005, 87: 508-512.CrossRefPubMed
16.
Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zdeblick TA: Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. 2007, 6: 198-209. 10.3171/spi.2007.6.3.198.CrossRefPubMed
17.
Heller JG, Sasso RC, Papadopoulos SM, Anderson PA, Fessler RG, Hacker RJ, Coric D, Cauthen JC, Riew DK: Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine. 2009, 34: 101-107. 10.1097/BRS.0b013e31818ee263.CrossRefPubMed
18.
Robertson JT, Papadopoulos SM, Traynelis VC: Assessment of adjacent-segment disease in patients treated with cervical fusion or arthroplasty: a prospective 2-year study. J Neurosurg Spine. 2005, 3: 417-423. 10.3171/spi.2005.3.6.0417.CrossRefPubMed
19.
Pimenta L, McAfee PC, Cappuccino A, Cunningham BW, Crockard A, Guerrero L: Adjacent level disease after cervical disc arthroplasty: a 3 years follow-up. Global Symposium on Motion Preservation Technology, Berlin. 2007
20.
Suchomel P: Artificial discs and spinal motion - use of ActivC. European Musculoskeletal Review. 2008, 3: 65-68.
21.
Miyazaki M, Hong SW, Yoon SH, Morishita Y, Wang JC: Reliability of a magnetic resonance imaging-based grading system for cervical intervertebral disc degeneration. J Spinal Disord Tech. 2008, 21: 288-292. 10.1097/BSD.0b013e31813c0e59.CrossRefPubMed
22.
Vernon H, Mior S: The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991, 14: 409-415.PubMed
23.
Pietrobon R, Coeytaux RR, Carey TS, Richardson WJ, DeVellis RF: Standard scales for measurement of functional outcome for cervical pain or dysfunction: a systematic review. Spine. 2002, 27: 515-522. 10.1097/00007632-200203010-00012.CrossRefPubMed
24.
Vos CJ, Verhagen AP, Koes BW: Reliability and responsiveness of the Dutch version of the Neck Disability Index in patients with acute neck pain in general practice. Eur Spine J. 2006, 15: 1729-1736. 10.1007/s00586-006-0119-7.CrossRefPubMed
25.
Ware JE, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992, 30: 473-483. 10.1097/00005650-199206000-00002.CrossRefPubMed
26.
Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L: Validating the SF-36 health survey questionnaire: new outcome measure for primary care. Bmj. 1992, 305: 160-164. 10.1136/bmj.305.6846.160.CrossRefPubMedPubMedCentral
27.
Stansfeld SA, Roberts R, Foot SP: Assessing the validity of the SF-36 General Health Survey. Qual Life Res. 1997, 6: 217-224. 10.1023/A:1026406620756.CrossRefPubMed
28.
Carlsson AM: Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983, 16: 87-101. 10.1016/0304-3959(83)90088-X.CrossRefPubMed
29.
Melzack R: The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975, 1: 277-299. 10.1016/0304-3959(75)90044-5.CrossRefPubMed
30.
Kloot WA, Vertommen H: De MPQ-DLV. Een nederlandstalige versie van de McGill Pain Questionnaire. Achtergronden en handleiding. 1989, Lisse: Swets en Zeitlinger
31.
Karasek R, Brisson C, Kawakami N, Houtman I, Bongers P, Amick B: The Job Content Questionnaire (JCQ): an instrument for internationally comparative assessments of psychosocial job characteristics. J Occup Health Psychol. 1998, 3: 322-355. 10.1037/1076-8998.3.4.322.CrossRefPubMed
32.
Houtman I: Reliability and validity of the Dutch version of the Karasek Job Content Questionnaire. NIOSH/APA conference on stress, work and health, Washinhton, DC. 1995
33.
Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983, 67: 361-370. 10.1111/j.1600-0447.1983.tb09716.x.CrossRefPubMed
34.
Bombardier C: Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine. 2000, 25: 3100-3103. 10.1097/00007632-200012150-00003.CrossRefPubMed
35.
Lamers LM, Stalmeier PF, McDonnell J, Krabbe PF, van Busschbach JJ: Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff. Ned Tijdschr Geneeskd. 2005, 149: 1574-1578.PubMed
36.
Brazier J, Roberts J, Deverill M: The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002, 21: 271-292. 10.1016/S0167-6296(01)00130-8.CrossRefPubMed
37.
Oostenbrink JB, Bouwmans CAM, Koopmanschap MA, Rutten FFH: Handleiding voor kostenonderzoek. 2004, Rotterdam: iMTA
38.
McAfee PC, Cunningham BW, Devine J, Williams E, Yu-Yahiro J: Classification of heterotopic ossification (HO) in artificial disk replacement. J Spinal Disord Tech. 2003, 16: 384-389.CrossRefPubMed
39.
ProMISe, version 2: Project Manager Internet Server. Leiden, The Netherlands. Department of Medical Statisctics and BioInformatics, Leiden University Medical Center.
40.
Gore DR: Roentgenographic findings in the cervical spine in asymptomatic persons: a ten-year follow-up. Spine. 2001, 26: 2463-2466. 10.1097/00007632-200111150-00013.CrossRefPubMed
41.
Okada E, Matsumoto M, Ichihara D, Chiba K, Toyama Y, Fujiwara H, Momoshima S, Nishiwaki Y, Hashimoto T, Ogawa J, Watanabe M, Takahata T: Aging of the cervical spine in healthy volunteers: a 10-year longitudinal magnetic resonance imaging study. Spine (Phila Pa 1976). 2009, 34: 706-712.CrossRef
42.
Bartels RH, Donk R, van der Wilt GJ, Grotenhuis JA, Venderink D: Design of the PROCON trial: a prospective, randomized multi-center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty. BMC Musculoskelet Disord. 2006, 7: 85-10.1186/1471-2474-7-85.CrossRefPubMedPubMedCentral
Metadata
Title
The NEtherlands Cervical Kinematics (NECK) Trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study
Authors
Mark P Arts
Ronald Brand
Elske van den Akker
Bart W Koes
Wilco C Peul
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2010
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-11-122

Other articles of this Issue 1/2010

BMC Musculoskeletal Disorders 1/2010 Go to the issue

Research article

An ex vivo continuous passive motion model in a porcine knee for assessing primary stability of cell-free collagen gel plugs

Research article

Hip and fragility fracture prediction by 4-item clinical risk score and mobile heel BMD: a women cohort study

Research article

Computer work and musculoskeletal disorders of the neck and upper extremity: A systematic review

Research article

Contributions of lean mass and fat mass to bone mineral density: a study in postmenopausal women

Research article

Clinical predictors of elective total joint replacement in persons with end-stage knee osteoarthritis

Research article

Prediction of grip and key pinch strength in 978 healthy subjects