| 1. |
- Kontakis, Michael G., et al.
(författare)
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Artificial disc replacement and adjacent-segment pathology : 10-year outcomes of a randomized trial
- 2022
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Ingår i: Journal of Neurosurgery. - : AMER ASSOC NEUROLOGICAL SURGEONS. - 1547-5654 .- 1547-5646. ; 36:6, s. 945-953
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Artificial disc replacement (ADR) is designed to preserve motion and thus protect against adjacent-segment pathology (ASP) and act as an alternative treatment to fusion surgery. The question remains, how well do ADR devices perform after 10 years of follow-up compared with fusion surgery in terms of patient satisfaction, sustainability, and protection against ASP?METHODS: This was the 10-year follow-up study of 153 participants who underwent ADR or fusion surgery after anterior decompression due to cervical degenerative radiculopathy (ISRCTN registration no. 44347115). Scores on the Neck Disability Index (NDI), EQ-5D, and visual analog scale for neck and arm pain were obtained from the Swedish Spine Registry and analyzed using ANCOVA. Information about secondary surgical procedures was collected from medical records and presented as Kaplan-Meier curves. MRI and flexion-extension radiography were performed, and ASP was graded according to the Miyazaki classification system.RESULTS: Ten participants were lost to follow-up, which left 143 participants (80 underwent ADR and 65 underwent anterior cervical discectomy and fusion). There were no differences between groups in terms of patient-reported outcome measures (10-year difference in NDI scores 1.7 points, 95% CI -5.1 to 8.5, p = 0.61). Nineteen (24%) participants in the ADR group compared with 9 (14%) in the fusion group underwent secondary surgical procedures. The higher reoperation rate of the ADR group was mainly due to 11 female participants with device loosening. The rates of reoperation due to ASP were similar between groups, which was confirmed with MRI assessment of ASP that also showed no differences between the groups (p = 0.21).CONCLUSIONS: This was the first 10-year follow-up study to compare ADR with fusion surgery and to provide MRI information for the assessment of ASP. The authors found no benefit of ADR over fusion surgery after anterior decompression for cervical degenerative radiculopathy.
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| 2. |
- MacDowall, Anna, et al.
(författare)
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Anxiety and depression affect pain drawings in cervical degenerative disc disease
- 2017
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Ingår i: Upsala Journal of Medical Sciences. - : TAYLOR & FRANCIS LTD. - 0300-9734 .- 2000-1967. ; 122:2, s. 99-107
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Pain drawings have been frequently used in the preoperative evaluation of spine patients. Until now most investigations have focused on low back pain patients, even though pain drawings are used in neck pain patients as well. The aims of this study were to investigate the pain drawing and its association to preoperative demographics, psychological impairment, and pain intensity. Methods: We carried out a post hoc analysis of a randomized controlled trial, comparing cervical disc replacement to fusion for radiculopathy related to degenerative disc disease. Preoperatively the patients completed a pain drawing, the Hospital Anxiety and Depression Scale (HADS), and a visual analogue scale (VAS). The pain drawing was evaluated according to four established methods, now modified for cervical conditions. Comparisons were made between the pain drawing and age, sex, smoking, and employment status as well as HADS and VAS. Results: Included were 151 patients, mean age of 47 years, female/male: 78/73. Pain drawing results were not affected by age, sex, smoking, and employment status. Patients with non-neurogenic pain drawings according to the modified method by Ransford had higher points on HADS-anxiety, HADS-depression, and HADS-total. Patients with markings in the head region had higher score on HADS-depression. Markings in the neck and lower arm region were associated with high values of VAS-neck and VAS-arm. Conclusions: Pain drawings were affected by both pain intensity and anxiety/depression in cervical spine patients. Therefore, the pain drawing can be a useful tool when interpreting the patients' pain in correlation to psychological impairment and pain location.
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| 3. |
- MacDowall, Anna, et al.
(författare)
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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
- 2019
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Ingår i: Journal of Neurosurgery. - 1547-5654 .- 1547-5646. ; 30:3, s. 323-331
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVEThe 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.METHODSThe 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.RESULTSScores 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.CONCLUSIONSIn 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.
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| 4. |
- MacDowall, Anna, et al.
(författare)
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Artificial Disc Replacement versus Fusion in Patients with Cervical Degenerative Disc Disease with radiculopathy : 5-year Outcomes from the National Swedish Spine Register
- 2019
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Ingår i: Journal of Neurosurgery. - 1547-5654 .- 1547-5646. ; 30:2, s. 159-167
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 5. |
- MacDowall, Anna, et al.
(författare)
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Comparison of posterior muscle-preserving selective laminectomy and laminectomy with fusion for treating cervical spondylotic myelopathy: study protocol for a randomized controlled trial
- 2023
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 24:1
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Tidskriftsartikel (refereegranskat)abstract
- Background Cervical spondylotic myelopathy (CSM) is the predominant cause of spinal cord dysfunction in the elderly. The patients are often frail and susceptible to complications. Posterior surgical techniques involving non-fusion are complicated by postlaminectomy kyphosis and instrumented fusion techniques by distal junction kyphosis, pseudarthrosis, or implant failure. The optimal surgical approach is still a matter of controversy.Since anterior and posterior fusion techniques have been compared without presenting any superiority, the objective of this study is to compare stand-alone laminectomy with laminectomy and fusion to determine which treatment has the lowest frequency of reoperations. Methods This is a multicenter randomized, controlled, parallel-group non-inferiority trial. A total of 300 adult patients are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason at 5 years of follow-up. Sample size and power calculation were performed by estimating the reoperation rate after laminectomy to 3.5% and after laminectomy with fusion to 7.4% based on the data from the Swedish spine registry (Swespine) on patients with CSM. Secondary outcomes are the patient-derived Japanese Orthopaedic Association (P-mJOA) score, Neck Disability Index (NDI), European Quality of Life Five Dimensions (EQ-5D), Numeric Rating Scale (NRS) for neck and arm pain, Hospital Anxiety and Depression Scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA), and death. Clinical and radiological follow-up is performed at 3, 12, 24, and 60 months after surgery. The main inclusion criterium is 1-4 levels of CSM in the subaxial spine, C3-C7. The REDcap software will be used for safe data management. Data will be analyzed according to the modified intention to treat (mITT) population, defined as randomized patients who are still alive without having emigrated or left the study after 2 and 5 years. Discussion This will be the first randomized controlled trial comparing two of the most common surgical treatments for CSM: the posterior muscle-preser ving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the myelopathy randomized controlled (MyRanC) study will provide surgical treatment recommendations for CSM. This may result in improvements in surgical treatment and clinical practice regarding CSM.
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| 6. |
- MacDowall, Anna, et al.
(författare)
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Effects of preoperative mental distress versus surgical modality, arthroplasty, or fusion on long-term outcome in patients with cervical radiculopathy
- 2018
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Ingår i: Journal of Neurosurgery. - : AMER ASSOC NEUROLOGICAL SURGEONS. - 1547-5654 .- 1547-5646. ; 29:4, s. 371-379
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE Several efforts have been made to investigate the long-term efficacy of artificial disc replacement surgery compared with that of fusion after decompression for the treatment of cervical degenerative disc disease and radiculopathy. However, research on the impact of mental distress on surgical treatment outcome has been sparse. The aim of the authors was to investigate the potential predictive value of preoperative risk factors in determining long-term outcome. METHODS A total of 153 patients (mean age 47 years) with single-or double-level cervical degenerative disc disease and radiculopathy were randomly assigned to undergo either anterior cervical discectomy and fusion (n = 70) or artificial disc replacement (n = 83). The primary outcome was the Neck Disability Index (NDI) score, a patient-reported function score that ranges from 0% to 100%; higher scores indicate greater disability. Preoperative variables such as sex, age, smoking status, employment status, having a strenuous job, neck pain duration, arm pain duration, amount of regular exercise, Hospital Anxiety and Depression Scale (HADS) score, NDI score, whether surgery was performed on 1 or 2 levels, and allocated treatment were analyzed in multiple linear regression models with the 5-year NDI score as the outcome. RESULTS A total of 47 (31%) patients had either a HADS anxiety or HADS depression score of 10 points or higher. High values on the preoperative HADS were a negative predictor of outcome (p = 0.009). Treatment allocation had no effect on 5-year NDI scores (p = 0.32). CONCLUSIONS Preoperative mental distress measured with the HADS affects long-term outcome in surgically treated patients with cervical radiculopathy.
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| 7. |
- MacDowall, Anna, et al.
(författare)
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Pain drawings predict outcome of surgical treatment for degenerative disc disease in the cervical spine
- 2017
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Ingår i: Upsala Journal of Medical Sciences. - : Uppsala Medical Society. - 0300-9734 .- 2000-1967. ; 122:3, s. 194-200
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Pain drawings have been frequently used in the preoperative evaluation of spine patients. For lumbar conditions comprehensive research has established both the reliability and predictive value, but for the cervical spine most of this knowledge is lacking. The aims of this study were to validate pain drawings for the cervical spine, and to investigate the predictive value for treatment outcome of four different evaluation methods.METHODS: We carried out a post hoc analysis of a randomized controlled trial, comparing cervical disc replacement to fusion for radiculopathy related to degenerative disc disease. A pain drawing together with Neck Disability Index (NDI) was completed preoperatively, after 2 and 5 years. The inter- and intraobserver reliability of four evaluation methods was tested using κ statistics, and its predictive value investigated by correlation to change in NDI.RESULTS: Included were 151 patients, mean age of 47 years, female/male: 78/73. The interobserver reliability was fair for the modified Ransford and Udén methods, good for the Gatchel method, and very good for the modified Ohnmeiss method. Markings in the shoulder and upper arm region on the pain drawing were positive predictors of outcome after 2 years of follow-up, and markings in the upper arm region remained a positive predictor of outcome even after 5 years of follow-up.CONCLUSIONS: Pain drawings were a reliable tool to interpret patients' pain prior to cervical spine surgery and were also to some extent predictive for treatment outcome.
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| 8. |
- MacDowall, Anna, et al.
(författare)
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Validation of the Visual Analogue Scale in the Cervical Spine
- 2018
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Ingår i: Journal of Eurosurgery. - Charlottesville, Virginia. - 1547-5654 .- 1547-5646. ; 28:3, s. 227-235
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Tidskriftsartikel (refereegranskat)abstract
- 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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| 9. |
- Marques, Catarina, 1969-, et al.
(författare)
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Unintended fusion in cervical artificial disk replacement : a prospective study on heterotopic ossification, progression, and clinical outcome, with 5-year follow-up
- 2021
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Ingår i: European spine journal. - : Springer. - 0940-6719 .- 1432-0932. ; 30:6, s. 1662-1669
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Tidskriftsartikel (refereegranskat)abstract
- Purpose Heterotopic ossification (HO) may cause unintended fusion in artificial disk replacement (ADR), failing to preserve motion. The reported incidence of HO varies hugely. This study aimed to determine prevalence of HO, progression, predisposing factors to occurrence and to progression, and potential effect on clinical outcomes. Methods Eighty-three patients treated with ADRs for cervical radiculopathy at one or two segments were extracted from a previously published RCT. Of the 83 patients, 59 had remaining ADR (79 implants) and sufficiently high-quality X-rays at 5 years of follow-up to allow analysis. HO was graded on plain films according to Mehren/Suchomel. Prevalence, progression, predisposing factors and effect on clinical outcome (Neck Disability Index-NDI) were analyzed. Results At 2 years, HO was seen in 46/55 ADR implants (84%), severe enough to affect mobility in 27/55 (49%). At 5 years, HO was seen in 92% of 79 implants, severe in 71%. Male sex was a predisposing factor to HO. No predisposing factors to progression were identified. NDI was not affected by the severity of HO. Conclusion Almost all ADR implants in our study have HO at 5 years of follow-up. Male sex is a risk factor. Severe HO did not affect clinical outcome.
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