| 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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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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| 6. |
- 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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| 7. |
- 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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| 8. |
- Marques, Catarina, 1969-, et al.
(författare)
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Accuracy and Reliability of X-ray Measurements in the Cervical Spine
- 2020
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Ingår i: Asian Spine Journal. - : KOREAN SOC SPINE SURGERY. - 1976-1902 .- 1976-7846. ; 14:2, s. 169-176
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Tidskriftsartikel (refereegranskat)abstract
- Study Design: This study is a post hoc analysis of a multicenter prospective randomized controlled trial which compared artificial disc replacement and anterior cervical discectomy and fusion. Purpose: Useful radiographic parameters for assessing cervical alignment include the Cobb angles, T1 slope (TS), occipitocervical inclination (OCI). K-line tilt (KLT), and cervical sagittal vertical axis (cSVA). This study aimed to determine measurement accuracy and reliability for these parameters. Overview of Literature: Various authors have assessed repeatability by comparing different methods of measurement, but knowledge of measurement error and minimal detectable change is scarce. Methods: We evaluated 75B lateral cervical radiographs. One medical student and one spine surgeon (i.e., measured x2 within 4 weeks) independently measured the parameters obtaining 5,850 values. Standard error of measurement (SEm) and minimum detectable change (MDC) were calculated for each parameter. The accuracy and reliability of the Cobb angle measurements were calculated for the different types of angles: cervical lordosis, prosthesis angle, segmental angle with two hone surfaces (SABB), and segmental angle with one bone and one metal surface. Reliability was determined with intraclass correlation coefficient (ICC). Results: SEm was 1.8 degrees and MDC was 5.0 degrees for the Cobb angle, with an intraobserver/interobserver ICC of 0.958/0.8B6. All the different subtypes of Cobb angles had an ICC higher than 0.950, except SABB (intraobserver/interobserver ICC of 0.922/0.716). The most accurate and reliable measurement was for KLT. Conclusions: This study provides normative data on SEm and MDC for Cobb angles, T1S, KLT, OCI, and cSVA in cervicalcervicai lateral radiographs. Reliability was excellent for all parameters except SABB (e.g., good).
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| 9. |
- Marques, Catarina, 1969-
(författare)
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Studies on Cervical Artificial Disc Replacement
- 2022
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Artificial disc replacement (ADR) was developed as an alternative to anterior fusion after decompression for cervical degenerative radiculopathy. By preserving motion, it was expected to prevent acceleration of adjacent segment pathology (ASP) associated with fusion, and lead to better clinical outcomes. The aims of this thesis were to evaluate whether ADR surgery leads to better outcomes than fusion surgery, to investigate if it prevents the acceleration of ASP, and to analyze its potential complications. In a multicenter randomized controlled trial (RCT) 153 patients were randomized to ADR (DiscoverTM implant) or fusion surgery (autograft, plate and screws). The outcomes at 5 and 10 years postoperatively were analyzed with Neck Disability Index (NDI) as primary measure. Heterotopic ossification (HO), ASP, and secondary surgery where analyzed. The measurements of radiographic parameters used in the assessment of cervical alignment where validated.To further analyze secondary surgery after ADR, a descriptive register cohort study was done with 42 patients whose data were retrieved from Swespine and completed with medical charts, images, and a telephone interview. There was no difference in NDI scores between groups in the RCT, 5 or 10 years postoperatively. Radiological and clinically significant ASP were similar in both groups. There was more secondary surgery in the ADR group compared with the fusion group, mainly due to device loosening in women. Severe HO was seen in 71% of the ADR implants 5 years postoperatively, and 27% were fused, male sex being a clear risk factor.Normative data for measurement error were provided on the cervical alignment measurements, and the most reliable were the K-line tilt and the cervical sagittal vertical axis (cSVA). In the 42 patients in the register cohort study the most common diagnosis leading to reoperation was loosening of the ADR implant and/or ASP, predominantly treated with fusion surgery. Reoperation resulted in good outcomes in the vast majority of patients. At the long-term, there is no clinical benefit of ADR over fusion surgery after decompression for cervical degenerative radiculopathy. ADR, compared with fusion surgery, does not prevent acceleration of ASP, and results in more reoperations. Revision surgery for failed cervical ADRs is effective and justified.
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| 10. |
- Marques, Catarina, 1969-, et al.
(författare)
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The fate of failed cervical arthroplasties: outcome of revision surgery
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Purpose: To analyze the diagnoses leading to secondary surgery, the surgical methods used in reoperations, and the final clinical outcomes, in patients reoperated after a primary reconstruction with a cervical artificial disc replacement (ADR). Methods: Descriptive cohort study of 42 ADR patients who underwent secondary surgery at the index or adjacent level. Data collected from the National Swedish Register for Spine Surgery 2006 through 2018, completed with information from patients’ charts, images, and a telephone interview with the patients. Analysis of time to reoperation, diagnosis leading to reoperation, surgical method, and outcome at 2 years, measured as change in neck pain, arm pain and function, as well as overall patient satisfaction. Results: The most common diagnosis leading to reoperation was loosening (n=16), clinical adjacent segment pathology (ASP) (n=8), or a combination thereof (n=6). Thirty-four of the surgeries were performed at the index level. Mean time to reoperation was 44 months.Reoperation consisted of extraction of the ADR and fusion surgery in 32 cases. Function improved after the reoperation in 32 patients. Twenty-four of 30 patients who had neck pain, and 28 of 32 who had arm pain improved after the reoperation. No patients reported post-operative aggravation of symptoms.Conclusion: Failure of ADR is mainly due to loosening of the implant and/or ASP, and is predominantly treated with fusion surgery. Reoperation results in good outcomes (complete or nearly complete recovery) in the vast majority of patients. We conclude that revision surgery for failed cervical arthroplasty is effective and justified.
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