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Sökning: WFRF:(Olerud Claes)

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  • 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. - 0940-6719 .- 1432-0932. ; 18:10, s. 1512-19
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. - 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.
  • 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.
  • Skeppholm, Martin, et al. (författare)
  • Evaluation of mobility and stability in the Discover artificial disc : an in vivo motion study using high-accuracy 3D CT data
  • 2015
  • Ingår i: Journal of Eurosurgery. - : AMER ASSOC NEUROLOGICAL SURGEONS. - 1547-5654 .- 1547-5646. ; 23:3, s. 383-389
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECT Artificial disc replacement (ADR) devices are unlike implants used in cervical fusion in that they are continuously exposed to stress not only within the implant site but also at their site of attachment to the adjacent vertebra. An imaging technique with higher accuracy than plain radiography and with the possibility of 3D visualization would provide more detailed information about the motion quality and stability of the implant in relation to the vertebrae. Such high-accuracy studies have previously been conducted with radiostereometric analysis (RSA), which requires implantation of tantalum markers in the adjacent vertebrae. The aim of this study was to evaluate in vivo motion and stability of implanted artificial discs. A noninvasive analysis was performed with CT, with an accuracy higher than that of plain radiographs and almost as high as RSA in cervical spine. METHODS Twenty-eight patients with ADR were included from a larger cohort of a randomized controlled trial comparing treatment of cervical radiculopathy with ADR or anterior cervical decompression and fusion. Surgical levels included C4-7; 18 patients had 1-level surgery and 10 patients had 2-level surgery. Follow-up time ranged from 19 to 50 months, with an average of 40 months. Two CT volumes of the cervical spine, 1 in flexion and 1 in extension, were obtained in each patient and then spatially registered using a customized imaging tool, previously used and validated for the cervical spine. Motion between the components in the artificial disc, as well as motion between the components and adjacent vertebrae, were calculated in 3 planes. Intraclass correlation (ICC) between independent observers and repeatability of the method were also calculated. RESULTS Intrinsic motion, expressed as degrees in rotation and millimeters in translation, was detectable in a majority of the ADRs. In the sagittal plane, in which the flexion/extension was performed, sagittal rotation ranged between 0.2 and 15.8 and translation between 0.0 and 5.5 mm. Eight percent of the ADRs were classified as unstable, as motion between at least 1 of the components and the adjacent vertebra was detected. Five percent were classified as ankylotic, with no detectable motion, and another 8% showed very limited motion due to heterotopic ossification. Repeatability for the motion in the sagittal plane was calculated to be 1.300 for rotation and 1.29 mm for translation (95% confidence level), ICC 0.99 and 0.84, respectively. All 3 patients with unstable devices had undergone 1-level ADRs at C5-6. They all underwent revision surgery due to increased neck pain, and instability was established during the surgery. CONCLUSIONS The majority of the artificial discs in this study showed intrinsic mobility several years after implantation and were also shown to be properly attached. Implant instability was detected in 8% of patients and, as all of these patients underwent revision surgery due to increasing neck pain, this might be a more serious problem than heterotopic bone formation.
  • Skeppholm, M, et al. (författare)
  • Pain from donor site after anterior cervical fusion with bone graft : a prospective randomized study with 12 months of follow-up
  • 2013
  • Ingår i: European spine journal. - 0940-6719 .- 1432-0932. ; 22:1, s. 142-147
  • Tidskriftsartikel (refereegranskat)abstract
    • INTRODUCTION:Harvesting bone graft from the iliac crest in spinal fusion surgery is a widely used technique. However, complications can occur and there are also reports of patients with persistent graft site pain after surgery. The aim of this study was to evaluate pain from the donor site (DS) over time, and register associated complications and if it affected health-related quality of life (HRQoL).MATERIAL AND METHODS:One hundred and seven patients participating in an RCT between two different methods of reconstruction after cervical decompression were included in this study. One group underwent surgery with bone graft (BG) from the iliac crest and the other with no bone graft (NBG). All patients were evaluated concerning pain at DS and HRQoL preoperatively, at 4  weeks, 3 months and 1 year. Pain was evaluated with visual analog scale (VAS) and HRQoL with EQ-5D.RESULTS: A statistically significant difference was found at all times of follow-up in the BG group compared to preoperative levels and the NBG group. The VAS levels at follow-ups at 3 months and 1 year were however of questionable clinical importance. Two patients in the BG group had superficial wound infections postoperatively and five patients still had sensory disturbance in the area of graft site at 12 months. No major complications were registered. No difference could be seen in EQ-5D at any time of follow-up between the groups.CONCLUSION:Harvesting of iliac crest bone graft is associated with significant pain. However, at 3 months postoperatively, the negative effect of clinical importance seemed to have disappeared compared to when no bone graft was harvested. The pain from bone graft harvesting does not seem to affect the quality of life at 4 weeks postoperatively and onward.
  • Skeppholm, Martin, et al. (författare)
  • The association between preoperative mental distress and patient-reported outcome measures in patients treated surgically for cervical radiculopathy
  • 2017
  • Ingår i: The spine journal. - 1529-9430 .- 1878-1632. ; 17:6, s. 790-798
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND CONTEXT: Previous research indicates that there might exist a link between the experience of pain and mental distress. Pain can possibly trigger anxiety and chronic pain, as well as also depression. On the other hand, anxiety and depression might also be risk factors for painful conditions and more pronounced subsequent disability and thus, the pathways may be bidirectional. Expanded knowledge of how different factors affect pain and function may help surgeons in preoperative decision-making.PURPOSE: The aim of this study was to evaluate the impact of potential preoperative risk factors with special reference to mental distress.STUDY DESIGN/SETTING: This is a prospective outcome study in a cohort from a multicenter randomized controlled trial comparing anterior cervical decompression and fusion with disc replacement.PATIENT SAMPLE: The sample included 151 patients with cervical radiculopathy planned for surgery.OUTCOME MEASURES: Surgical outcome was evaluated with Neck Disability Index (NDI), health related quality-of-life with European Quality of Life-5 Dimensions, and pain with visual analogue scale for arm and neck. Mental distress was preoperatively measured with the Hospital Anxiety and Depression (HAD) scale.METHODS: Preoperative data regarding possible risk factors for poor outcome were analyzed in multiple linear regression models with postoperative NDI and change of NDI as dependent factors. Patients with high preoperative levels of anxiety or depression (H-HAD), indicating mental distress, were compared with patients scoring low/moderate levels (L-HAD) regarding patient-reported outcome measures (PROMs) preoperatively and at 1- and 2-year follow-up.RESULTS: Outcome data were available for 136 patients at the 2-year follow-up. No statistically significant difference in any outcome data could be demonstrated between the two surgical treatment groups. Mental distress was the variable most strongly associated with NDI at 2 years in the regression analysis. There were 42 patients classified as H-HAD and 94 as L-HAD. The average improvement in NDI was 16.9 in the H-HAD group and 26.3 in the L-HAD group, p=.02. The H-HAD patients showed a tendency for poorer baseline data and worse outcome overall in all PROMs at follow-up at both 1 and 2 years.CONCLUSIONS: Preoperative mental distress measured with HAD was associated with worse outcome overall. More research is needed to investigate whether patients with mental distress may achieve better results if other treatments are offered, either as non-surgical treatment alone or as an adjunct to surgery.
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