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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.
  • 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 Discover artificial disc replacement versus fusion in cervical radiculopathy-a randomized controlled outcome trial with 2-year follow-up
  • 2015
  • Ingår i: The spine journal. - 1529-9430 .- 1878-1632. ; 15:6, s. 1284-1294
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND CONTEXT: Several previous studies comparing artificial disc replacement (ADR) and fusion have been conducted with cautiously positive results in favor of ADR. This study is not, in contrast to most previous studies, an investigational device exemption study required by the Food and Drug Administration for approval to market the product in the United States. This study was partially funded with unrestricted institutional research grants by the company marketing the artificial disc used in this study. PURPOSE: To compare outcomes between the concepts of an artificial disc to treatment with anterior cervical decompression and fusion (ACDF) and to register complications associated to the two treatments during a follow-up time of 2 years. STUDY DESIGN/SETTING: This is a randomized controlled multicenter trial, including three spine centers in Sweden. PATIENT SAMPLE: The study included patients seeking care for cervical radiculopathy who fulfilled inclusion criteria. In total, 153 patients were included. OUTCOME MEASURES: Self-assessment with Neck Disability Index (NDI) as a primary outcome variable and EQ-5D and visual analog scale as secondary outcome variables. METHODS: Patients were randomly allocated to either treatment with the Depuy Discover artificial disc or fusion with iliac crest bone graft and plating. Randomization was blinded to both patient and caregivers until time for implantation. Adverse events, complications, and revision surgery were registered as well as loss of follow-up. RESULTS: Data were available in 137 (91%) of the included and initially treated patients. Both groups improved significantly after surgery. NDI changed from 63.1 to 39.8 in an intention-to-treat analysis. No statistically significant difference between the ADR and the ACDF groups could be demonstrated with NDI values of 39.1 and 40.1, respectively. Nor in secondary outcome measures (EQ-5D and visual analog scale) could any statistically significant differences be demonstrated between the groups. Nine patients in the ADR group and three in the fusion group underwent secondary surgery because of various reasons. Two patients in each group underwent secondary surgery because of adjacent segment pathology. Complication rates were not statistically significant between groups. CONCLUSIONS: Artificial disc replacement did not result in better outcome compared to fusion measured with NDI 2 years after surgery.
  • Skeppholm, Martin, et al. (författare)
  • The Dysphagia Short Questionnaire : An Instrument for Evaluation of Dysphagia: A Validation Study With 12 Months' Follow-up After Anterior Cervical Spine Surgery
  • 2012
  • Ingår i: Spine. - 0362-2436 .- 1528-1159. ; 37:11, s. 996-1002
  • Tidskriftsartikel (refereegranskat)abstract
    • Study Design. Prospective clinical validation study of questionnaire to assess dysphagia. Objective. To test validity and reliability of Dysphagia Short Questionnaire (DSQ), and also to determine levels of dysphagia over time after anterior cervical spine surgery (ACSS). Summary of Background Data. Dysphagia is common after ACSS but reports on the incidence vary widely between 1% and 79%, indicating an evaluation problem. Several tools for evaluation of dysphagia exist but common features are that they are cumbersome to use and usually are designed for patients with neurological or malignant diseases in the neck region. Others are not validated, for example, the Bazaz score. There is, thus, a need for a more adapted tool to evaluate dysphagia in patients undergoing ACSS. Methods. The DSQ was constructed in collaboration with a group of ear-nose-and-throat specialists. In a first validation study, 45 patients with stationary dysphagia for various reasons completed the DSQ twice 2 weeks apart, the M. D. Anderson Dysphagia Inventory (MDADI), the Bazaz score, and a quality-of-life score, the EQ-5D. To evaluate the utility of the DSQ, a second validation study was performed, where 111 subjects undergoing ACSS for degenerative disk disease completed the form preoperatively and at 4 weeks, 3 months, and 1 year after surgery. Results. In the first study, the DSQ correlated to MDADI (r = 0.59) and showed good reproducibility. The Bazaz score did not correlate to the DSQ, the MDADI, or the EQ-5 D. In the second study, dysphagia was present in a few patients already preoperatively. At 4 weeks, 85% of the patients reported dysphagia. The level had dropped significantly at 3 months and had returned to baseline levels at 1 year. Conclusion. We consider the DSQ to be a validated tool for the assessment of dysphagia in ACSS patients. Dysphagia after ACSS for cervical spondylosis is common but the symptoms on a group level are not very severe and are also temporary.
  • Berg, Svante, 1953- (författare)
  • On Total Disc Replacement
  • 2010
  • Doktorsavhandling (övrigt vetenskapligt)abstract
    • Low back pain consumes a large part of the community’s resources dedicated to health care and sick leave. Back disorders also negatively affect the individual leading to pain suffering, decreased quality-of-life and disability. Chronic low back pain (CLBP) due to degenerative disc disease (DDD) is today often treated with fusion when conservative treatment has failed and symptoms are severe. This treatment is as successful as arthroplasty is for hip arthritis in restoring the patient’s quality of life and reducing disability. Even so, there are some problems with this treatment, one of these being recurrent CLBP from an adjacent segment (ASD) after primarily successful surgery. This has led to the development of alternative surgical treatments and devices that maintain or restore mobility, in order to reduce the risk for ASD. Of these new devices, the most frequently used are the disc prostheses used in Total Disc Replacement (TDR).This thesis is based on four studies comparing total disc replacement with posterior fusion. The studies are all based on a material of 152 patients with DDD in one or two segments, aged 20-55 years that were randomly treated with either posterior fusion or TDR.The first study concerned clinical outcome and complications. Follow-up was 100% at both one and two years. It revealed that both treatment groups had a clear benefit from treatment and that patients with TDR were better in almost all outcome scores at one-year follow-up. Fusion patients continued to improve during the second year. At two-year follow-up there was a remaining difference in favour of TDR for back pain. 73% in the TDR group and 63% in the fusion group were much better or totally pain-free (n.s.), while twice as many patients in the TDR group were totally pain free (30%) compared to the fusion group (15%).Time of surgery and total time in hospital were shorter in the TDR group.There was no difference in complications and reoperations, except that seventeen of the patients in the fusion group were re-operated for removal of their implants.The second study concerned sex life and sexual function. TDR is performed via an anterior approach, an approach that has been used for a long time for various procedures on the lumbar spine. A frequent complication reported in males when this approach is used is persistent retrograde ejaculation. The TDR group in this material was operated via an extra-peritoneal approach to the retroperitoneal space, and there were no cases of persistent retrograde ejaculation. There was a surprisingly high frequency of men in the fusion group reporting deterioration in ability to have an orgasm postoperatively.Preoperative sex life was severely hampered in the majority of patients in the entire material, but sex life underwent a marked improvement in both treatment groups by the two-year follow-up that correlated with reduction in back pain.The third study was on mobility in the lumbar spinal segments, where X-rays were taken in full extension and flexion prior to surgery and at two-year follow-up. Analysis of the films showed that 78% of the patients in the fusion group reached the surgical goal (non-mobility) and that 89% of the TDR patients maintained mobility.Preoperative disc height was lower than in a normative database in both groups, and remained lower in the fusion group, while it became higher in the TDR group. Mobility in the operated segment increased in the TDR group postoperatively. Mobility at the rest of the lumbar spine increased in both treatment groups. Mobility in adjacent segments was within the norm postoperatively, but slightly larger in the fusion group.In the fourth study the health economics of TDR vs Fusion was analysed. The hospital costs for the procedure were higher for patients in the fusion group compared to the TDR group, and the TDR patients were on sick-leave two months less.In all, these studies showed that the results in the TDR group were as good as in the fusion group. Patients are more likely to be totally pain-free when treated with TDR compared to fusion. Treatment with this new procedure seems justified in selected patients at least in the short-term perspective. Long-term follow-up is underway and results will be published in due course.
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