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Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.ORCID iD: 0000-0002-9231-7608
Department of Clinical Neuroscience (CNS), K8, Karolinska Universitetssjukhuset Solna, Stockholm.ORCID iD: 0000-0001-5503-1793
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.ORCID iD: 0000-0002-5530-2909
Karolinska Inst, Med Management Ctr, Hlth Econ & Hlth Evaluat Res Grp, Dept Learning Informat Management & Eth LIME, Stockholm, Sweden;Sophiahemmets Sjukhus, Ctr Spine Surg Stockholm, Stockholm, Sweden.ORCID iD: 0000-0001-9901-6886
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2019 (English)In: Journal of Neurosurgery: Spine, ISSN 1547-5654, E-ISSN 1547-5646, Vol. 30, no 3, p. 323-331Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE

The method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserving the motion of ADR devices aims to prevent immobilization side effects such as adjacent-segment pathology (ASP). However, long-term follow-up evaluations using MRI are needed to investigate if this intent is achieved.

METHODS

The authors performed a randomized controlled trial with 153 patients (mean age 47 years) undergoing surgery for cervical radiculopathy. Eighty-three patients received an ADR and 70 patients underwent fusion surgery. Outcomes after 5 years were assessed using patient-reported outcome measures using the Neck Disability Index (NDI) score as the primary outcome; motion preservation and heterotopic ossification by radiography; ASP by MRI; and secondary surgical procedures.

RESULTS

Scores on the NDI were approximately halved in both groups: the mean score after 5 years was 36 (95% confidence interval [CI] 31–41) in the ADR group and 32 (95% CI 27–38) in the fusion group (p = 0.48). There were no other significant differences between the groups in six other patient-related outcome measures. Fifty-four percent of the patients in the ADR group preserved motion at the operated cervical level and 25% of the ADRs were spontaneously fused. Seventeen ADR patients (21%) and 7 fusion patients (10%) underwent secondary surgery (p = 0.11), with 5 patients in each group due to clinical ASP.

CONCLUSIONS

In patients with cervical DDD and radiculopathy decompression as well as ADR, surgery did not result in better clinical or radiological outcomes after 5 years compared with decompression and fusion surgery.

Place, publisher, year, edition, pages
2019. Vol. 30, no 3, p. 323-331
Keywords [en]
artificial disc replacement, treatment outcome, Neck Disability Index, cervical radiculopathy, adjacent-segment pathology
National Category
Orthopaedics Neurology
Research subject
Orthopaedics
Identifiers
URN: urn:nbn:se:uu:diva-345965DOI: 10.3171/2018.9.SPINE18659ISI: 000462447900004PubMedID: 30641852OAI: oai:DiVA.org:uu-345965DiVA, id: diva2:1190049
Projects
Cervical radiculopathy, studies on pain analysis and treatment
Note

Title in thesis list of papers: Artificial Disc Replacement versus Fusion in Patients with Cervical Degenerative Disc Disease with radiculopathy ‒ 5-year Outcomes

Available from: 2018-03-13 Created: 2018-03-13 Last updated: 2019-04-16Bibliographically approved
In thesis
1. Cervical Radiculopathy: Studies on Pain Analysis and Treatment
Open this publication in new window or tab >>Cervical Radiculopathy: Studies on Pain Analysis and Treatment
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background: Knowledge about how to interpret pain-analyzing tools such as the pain drawing test and the visual analog scale (VAS) in cervical spine patients are sparse; hence, they have never been validated for this subgroup of patients. The method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserved motion of ADR devices aims to prevent immobilization side effects such as stiffness, dysphagia and adjacent segment pathology. Long-term follow-ups of these devices compared with the gold standard treatment are needed to create future guidelines.

Objectives: This thesis aims at (1) validating the pain drawing as an investigational tool for the cervical spine, (2) validating the VAS for the cervical spine regarding the measurement noise and the minimum clinically important difference (MCID), (3) comparing ADR with fusion surgery at 5-years of follow-up regarding outcome and complications in a randomized controlled trial (RCT) as well as in the Swedish spine (Swespine) registry, and (4) investigating possible predictors to outcome after surgical treatment of cervical radiculopathy.

Methods: An RCT with 153 patients undergoing surgery for cervical radiculopathy was performed. Baseline data, the Neck disability index (NDI), two sets of VAS-neck and VAS-arm scores, the EQ-5D, Hospital anxiety and depression scale (HADS), Dysphagia short questionnaire and a pain drawing test were gathered preoperatively and after 5 years. Radiographs in flexion/extension and MRIs were done preoperatively and at follow-up. All patients registered in Swespine since January 1st, 2006 with cervical DDD and radiculopathy treated with ADR or fusion surgery, were included. Baseline data, the NDI, EQ-5D, and VAS-neck and VAS-arm scores were analyzed at 1, 2, 5 and 10-years of follow-up as well as the information regarding secondary surgeries.

Results: Pain drawings interpreted with the simple body region method showed good inter-rater reliability in cervical spine patients. Markings in the upper arm region on the pain drawing predicted surgical treatment outcome and markings in the head region predicted depression. The measurement noise was ~10 mm and the MCID was ~20 mm on a 100 mm pain VAS. In both the RCT and Swespine register the outcome after ADR surgery were comparable with fusion at 5 years of follow-up, except for an elevated risk regarding secondary surgery on the index level in the ADR group. Fifty percent of the patients in the RCT, allocated to ADR surgery had preserved motion of less than 5°, at the 5-year follow-up, and 25%, mostly men were spontaneously fused. Preserved motion did not prevent adjacent segment pathology. High values of preoperative HADS scores were negative predictors of outcome.

Conclusions: In patients with cervical DDD and radiculopathy both the pain drawing test and the VAS are validated tools to interpret the patients’ pain. Preoperative mental distress affects long-term outcome much more than the allocated treatment, ADR or fusion surgery in patients with cervical radiculopathy.

Clinical Trial Registration: ISRCTN, registration number: 44347115.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2018. p. 111
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1442
Keywords
Cervical radiculopahy, Artificial disc replacement
National Category
Orthopaedics
Research subject
Orthopaedics
Identifiers
urn:nbn:se:uu:diva-345977 (URN)978-91-513-0272-0 (ISBN)
Public defence
2018-05-05, Gustavianum, Akademigatan 3, Uppsala, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2018-04-10 Created: 2018-03-13 Last updated: 2018-04-10

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MacDowall, AnnaMarques, CatarinaLindhagen, LarsRobinson, YohanMichaëlsson, KarlOlerud, Claes

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