| 1. |
- Berg, Svante, et al.
(författare)
-
Total disc replacement compared to lumbar fusion : a randomised controlled trial with 2-year follow-up
- 2009
-
Ingår i: EUROPEAN SPINE JOURNAL. - : Springer Science and Business Media LLC. - 0940-6719 .- 1432-0932. ; 18:10, s. 1512-1519
-
Tidskriftsartikel (refereegranskat)abstract
- The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21-55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment (GA), VAS for back and leg pain, Oswestry Disability Index, SF36 and EQ5D at 1 and 2 years. Follow-up rate was 100%, at both 1 and 2 years. All outcome variables improved in both groups between preoperative and follow-up assessment. The primary outcome measure, GA, revealed that 30% in the TDR group and 15% in the fusion group were totally pain-free at 2 years (P = 0.031). TDR patients had reached maximum recovery in virtually all variables at 1 year, with significant differences compared to the fusion group. The fusion patients continued to improve and at 2 years had results similar to TDR patients apart from numbers of pain-free. Complications and reoperations were similar in both groups, but pedicle screw removal as additive surgery, was frequent in the fusion group. One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free. The long-term benefits have yet to be examined.
|
|
| 2. |
- Kontakis, Michael G., et al.
(författare)
-
Artificial disc replacement and adjacent-segment pathology : 10-year outcomes of a randomized trial
- 2022
-
Ingår i: Journal of Neurosurgery. - : AMER ASSOC NEUROLOGICAL SURGEONS. - 1547-5654 .- 1547-5646. ; 36:6, s. 945-953
-
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.
|
|
| 3. |
- MacDowall, Anna, et al.
(författare)
-
Anxiety and depression affect pain drawings in cervical degenerative disc disease
- 2017
-
Ingår i: Upsala Journal of Medical Sciences. - : TAYLOR & FRANCIS LTD. - 0300-9734 .- 2000-1967. ; 122:2, s. 99-107
-
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.
|
|
| 4. |
- MacDowall, Anna, et al.
(författare)
-
Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy : a randomized controlled trial with 5-year outcomes
- 2019
-
Ingår i: Journal of Neurosurgery. - 1547-5654 .- 1547-5646. ; 30:3, s. 323-331
-
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.
|
|
| 5. |
- MacDowall, Anna, et al.
(författare)
-
Artificial Disc Replacement versus Fusion in Patients with Cervical Degenerative Disc Disease with radiculopathy : 5-year Outcomes from the National Swedish Spine Register
- 2019
-
Ingår i: Journal of Neurosurgery. - 1547-5654 .- 1547-5646. ; 30:2, s. 159-167
-
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.
|
|
| 6. |
- MacDowall, Anna, et al.
(författare)
-
Effects of preoperative mental distress versus surgical modality, arthroplasty, or fusion on long-term outcome in patients with cervical radiculopathy
- 2018
-
Ingår i: Journal of Neurosurgery. - : AMER ASSOC NEUROLOGICAL SURGEONS. - 1547-5654 .- 1547-5646. ; 29:4, s. 371-379
-
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.
|
|
| 7. |
- MacDowall, Anna, et al.
(författare)
-
Pain drawings predict outcome of surgical treatment for degenerative disc disease in the cervical spine
- 2017
-
Ingår i: Upsala Journal of Medical Sciences. - : Uppsala Medical Society. - 0300-9734 .- 2000-1967. ; 122:3, s. 194-200
-
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.
|
|
| 8. |
- MacDowall, Anna, et al.
(författare)
-
Validation of the Visual Analogue Scale in the Cervical Spine
- 2018
-
Ingår i: Journal of Eurosurgery. - Charlottesville, Virginia. - 1547-5654 .- 1547-5646. ; 28:3, s. 227-235
-
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.
|
|
| 9. |
- Marques, Catarina, 1969-, et al.
(författare)
-
Unintended fusion in cervical artificial disk replacement : a prospective study on heterotopic ossification, progression, and clinical outcome, with 5-year follow-up
- 2021
-
Ingår i: European spine journal. - : Springer. - 0940-6719 .- 1432-0932. ; 30:6, s. 1662-1669
-
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.
|
|
| 10. |
- Skeppholm, Martin, et al.
(författare)
-
Comparison of dysphagia between cervical artificial disc replacement and fusion : data from a randomized controlled study with two years of follow-up
- 2013
-
Ingår i: Spine. - 0362-2436 .- 1528-1159. ; 38:24, s. E1507-E1510
-
Tidskriftsartikel (refereegranskat)abstract
- STUDY DESIGNProspective randomized controlled trial.OBJECTIVETo determine and explain any differences in self-reported dysphagia between patients treated with artificial disc replacement and anterior cervical decompression and fusion (ACDF).SUMMARY OF BACKGROUND DATADysphagia after anterior cervical spine surgery has in previous studies been evaluated regarding different influencing factors. Surgical technique, number of treated levels, and type of implant has been shown to be of possible importance.METHODSOne hundred thirty-six patients from a randomized controlled trial between artificial disc replacement and ACDF in 1 or 2 surgical levels were evaluated regarding dysphagia. Evaluation was done with the dysphagia short questionnaire preoperatively, at 4 weeks, 3 months, and 1 and 2 years postoperatively. Reconstruction in the artificial disc replacement group was performed with the Discover artificial disc. Bone graft and anterior plating was used in the ACDF group. Type of implant was blinded to the patients and the surgeon until time of implantation.RESULTSDemographics and dysphagia short questionnaire levels were similar in both groups preoperative. At 4 weeks of follow-up postoperatively, dysphagia was significantly higher in both groups than baseline levels, P < 0.01. No significant differences were seen between the groups until follow-up at 2 years, which showed significantly higher dysphagia short questionnaire levels in the ACDF group, P = 0.04. The difference was statistically significant in both patients treated with 1- and 2-level surgery, P = 0.029 and P = 0.032, respectively. A logistic regression model showed a stronger association to type of implant than to number of surgical levels. Duration of surgery was highly associated to number of surgical levels but did not differ significantly between types of implant.CONCLUSIONLong-term postoperative dysphagia could be explained by bulk of implant or decreased motion in the cervical spine. However, it is doubtful if differences between the groups in this study can be interpreted as a clinically important difference.
|
|
