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  • 1.
    MacDowall, Anna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Canto Moreira, Nuno
    Department of Clinical Neuroscience (CNS), K8, Karolinska Universitetssjukhuset Solna, Stockholm.
    Marques, Catarina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Skeppholm, Martin
    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.
    Lindhagen, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Robinson, Yohan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Löfgren, Håkan
    Länssjukhuset Ryhov, Jönköping.
    Michaëlsson, Karl
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Olerud, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes2019In: Journal of Neurosurgery: Spine, ISSN 1547-5654, E-ISSN 1547-5646, Vol. 30, no 3, p. 323-331Article in journal (Refereed)
    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.

  • 2.
    MacDowall, Anna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Skeppholm, Martin
    Institutionen för lärande, informatik, management och etik. Department for learning, informatics, management and ethics.
    Lindhagen, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Robinson, Yohan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Löfgren, Håkan
    Department of Neuro-Orthopaedic Center, Jönköping, Sweden.
    Michaëlsson, Karl
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Olerud, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Artificial Disc Replacement versus Fusion in Patients with Cervical Degenerative Disc Disease with radiculopathy: 5-year Outcomes from the National Swedish Spine Register2019In: Journal of Neurosurgery: Spine, ISSN 1547-5654, E-ISSN 1547-5646, Vol. 30, no 2, p. 159-167Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: The long-term efficacy of artificial disc replacement (ADR) surgery compared with fusion after decompression for the treatment of cervical degenerative disc disease and radiculopathy has not previously been investigated in a population-based setting.

    METHODS: All patients with cervical degenerative disc disease and radiculopathy who were in the national Swedish Spine Registry (Swespine) beginning in January 1, 2006, were eligible for the study. Follow-up information was obtained up to November 15, 2017. The authors compared, using propensity score matching, patients treated with anterior decompression and insertion of an ADR with patients who underwent anterior decompression combined with fusion surgery. The primary outcome was the Neck Disability Index (NDI), a patient-reported function score ranging from 0% to 100%, with higher scores indicating greater disability and a minimum clinically important difference of > 15%.

    RESULTS: A total of 3998 patients (2018: 1980 women/men) met the inclusion criteria, of whom 204 had undergone arthroplasty and 3794 had undergone fusion. After propensity score matching, 185 patients with a mean age of 49.7 years remained in each group. Scores on the NDI were approximately halved in both groups after 5 years, but without a significant mean difference in NDI (3.0%; 95% CI -8.4 to 2.4; p = 0.28) between the groups. There were no differences between the groups in EuroQol-5 Dimensions or in pain scores for the neck and arm.

    CONCLUSIONS: In patients with cervical degenerative disc disease and radiculopathy, decompression plus ADR surgery did not result in a clinically important difference in outcomes after 5 years, compared with decompression and fusion surgery.

  • 3.
    MacDowall, Anna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences.
    Skeppholm, Martin
    Institutionen för lärande, informatik, management och etik. Department for learning, informatics, management and ethics.
    Lindhagen, Lars
    Uppsala Clinical Research.
    Robinson, Yohan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences.
    Olerud, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences.
    Preoperative mental distress is more important for long-term outcome than the difference between surgical modalities, arthroplasty or fusion in patients with cervical radiculopathy2018In: Journal of Neurosurgery: Spine, ISSN 1547-5654Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: Several efforts have been made to investigate the long-term efficacy of artificial disc replacement surgery compared with fusion after decompression for the treatment of cervical degenerative disc disease and radiculopathy. However, research about the impact of mental distress on surgical treatment outcome is sparse. Our aim was to investigate the potential predictive value of preoperative risk factors to long-term outcome.

    METHODS: We randomly assigned 153 patients (mean age 47 years) with single- or double-level cervical degenerative disc disease and radiculopathy to receive either anterior cervical discectomy and fusion (n=70) or artificial disc replacement (ADR, n=83). The primary outcome was the Neck Disability Index (NDI), a patient-reported function score that ranges from 0 to 100%, with higher scores indicating greater disability. Preoperative variables such as sex, age, smoking, employment status, strenuous job, neck pain duration, arm pain duration, exercise, Hospital Anxiety and Depression Scale (HADS) scores, NDI and if one- or two-levels of surgery were performed as well as the allocated treatment were analyzed in multiple linear regression models with 5-year NDI as outcome.

    RESULTS: There were 47 patients (32%) with either HADS anxiety or HADS depression scores of 10 points or more. High values on preoperative HADS were negative predictors of outcome (P = 0.009). Treatment allocation had no effect on 5-year NDI (P = 0.32).

    CONCLUSION: Preoperative mental distress measured with HADS score affects long-term outcome in surgically treated patients with cervical radiculopathy.

    Trial registration: The study was registered at ISRCTN (registration number: 44347115).

  • 4.
    MacDowall, Anna
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Skeppholm, Martin
    Institutionen för lärande, informatik, management och etik. Department for learning, informatics, management and ethics, Karolinska institutet, Stockholm, Sweden.
    Robinson, Yohan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Olerud, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Validation of the Visual Analogue Scale in the Cervical Spine2018In: Journal of Eurosurgery : Spine, ISSN 1547-5654, E-ISSN 1547-5646, Vol. 28, no 3, p. 227-235Article in journal (Refereed)
    Abstract [en]

    Objective: The Visual analogue scale (VAS) is frequently used to measure treatment outcome in patients with cervical spine disorders. The minimum clinically important difference (MCID) is the smallest change in a score that has clinical importance to the patient. Although it has been established for other medical fields, knowledge of the VAS MCID for the cervical spine is sparse, and it has rarely been considered in relation to measurement noise. The goals in this study were as follows: 1) to validate the VAS-neck and VAS-arm instruments for the cervical spine (e.g. repeatability); 2) to investigate the possible influence of predictive factors and the Hospital Anxiety and Depression Scale (HADS) score on repeatability; and 3) to compute the MCID with five different methods.

    Methods: A post hoc analysis of a prospective randomized controlled trial with 151 patients undergoing surgery for cervical radiculopathy due to degenerative disc disease (DDD) was performed. Information on age, sex, smoking habits, exercise and employment status, HADS score, and VAS-neck and VAS-arm scores was gathered before surgery and after 1 year. The VAS was applied twice on every occasion with 15 minutes in-between. Repeatability and the association with predictors and HADS score were analyzed using the one-sample t-test, linear regression models and Spearman correlation. The MCID was calculated with the following methods: average change, change difference, receiver operating characteristic curve, effect size, and minimum detectable change (MDC).

    Results: The repeatability in VAS-neck was 8.1 mm and in VAS-arm 10.4 mm. Less consistent values on the VAS correlated to female sex and higher values on HADS. For VAS-neck the MCID ranged from 4.6 to 21.4 and for VAS-arm it ranged from 1.1 to 29.1. The highest MCID came from the MDC method, which was the only method that gave values above the measurement noise in both VAS-neck and VAS-arm.

    Conclusions: Measurement noise in VAS-neck and VAS-arm for the cervical spine was influenced by female sex and HADS score. The only method to compute MCID that consistently gave results above the measurement noise in VAS-neck and VAS-arm was the MDC. 

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