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result(s) for
"Spinal Diseases -- surgery"
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Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes
2015
BACKGROUND:Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain.
OBJECTIVE:To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction.
METHODS:A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete.
RESULTS:Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (≥ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P < .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31).
CONCLUSION:This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment.
ABBREVIATIONS:EQ-5D, EuroQoL-5DINSITE, Investigation of Sacroiliac Fusion TreatmentMCS, mental component summaryNSM, nonsurgical managementODI, Oswestry Disability IndexPCS, physical component summaryRFA, radiofrequency ablationSF-36, Short Form-36SIJ, sacroiliac jointTTO, time trade-offVAS, visual analog scale
Journal Article
State of the Art in Degenerative Cervical Myelopathy: An Update on Current Clinical Evidence
by
Shamji, Mohammed F.
,
Kim, Jun
,
Mroz, Thomas
in
Cervical Vertebrae
,
Decompression, Surgical
,
Diskectomy
2017
Abstract
Degenerative cervical myelopathy (DCM) is a common cause of spinal cord dysfunction that confronts clinicians on a daily basis. Research performed over the past few decades has provided improved insight into the diagnosis, evaluation, and treatment of this disorder. We aim to provide clinicians with an update regarding the state of the art in DCM, focusing on more recent research pertaining to pathophysiology, natural history, treatment, consideration of the minimally symptomatic patient, surgical outcome prediction, and outcome measurement. Current concepts of pathophysiology focus on the combination of static and dynamic elements leading to breakdown of the blood–spinal cord barrier at the site of compression resulting in local inflammation, cellular dysfunction, and apoptosis. With respect to treatment, although there is a dearth of high-quality studies comparing surgical to nonoperative treatment, several large prospective studies have recently associated surgical management with clinically and statistically significant improvement in functional, disability, and quality of life outcome at long-term follow-up. When selecting the specific surgical intervention for a patient with DCM, anterior (discectomy, corpectomy, hybrid discectomy/corpectomy), posterior (laminectomy and fusion, laminoplasty), and combined approaches may be considered as options depending on the specifics of the patient in question; evidence supporting each of these approaches is reviewed in detail. Recently developed clinical prediction models allow for accurate forecasting of postoperative outcomes, permitting enhanced communication and management of patient expectations in the preoperative setting. Finally, an overview of outcome measures recommended for use in the assessment of DCM patients is provided.
Journal Article
Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience
by
Schizas, Constantin
,
Kosmopoulos, Victor
,
Tsiridis, Elefterios
in
Blood Loss, Surgical
,
Bone Screws
,
Degenerative disc disease
2009
The aim of this study was to compare our experience with minimally invasive transforaminal lumbar interbody fusion (MITLIF) and open midline transforaminal lumbar interbody fusion (TLIF). A total of 36 patients suffering from isthmic spondylolisthesis or degenerative disc disease were operated with either a MITLIF (
n
= 18) or an open TLIF technique (
n
= 18) with an average follow-up of 22 and 24 months, respectively. Clinical outcome was assessed using the visual analogue scale (VAS) and the Oswestry disability index (ODI). There was no difference in length of surgery between the two groups. The MITLIF group resulted in a significant reduction of blood loss and had a shorter length of hospital stay. No difference was observed in postoperative pain, initial analgesia consumption, VAS or ODI between the groups. Three pseudarthroses were observed in the MITLIF group although this was not statistically significant. A steeper learning effect was observed for the MITLIF group.
Journal Article
Early initiation of a strength training based rehabilitation after lumbar spine fusion improves core muscle strength: a randomized controlled trial
2018
Background
To analyze the safety and effects of early initiation of rehabilitation including objective measurement outcomes after lumbar spine fusion based on principles of strength training.
Methods
The study recruited 27 patients, aged 45 to 70 years, who had undergone lumbar spine fusion. The method of concealed random allocation without blocking was used to form two groups. The strength training group started rehabilitation 3 weeks after surgery. Patients exercised twice weekly over 9 weeks focusing on muscle activation of lumbopelvic stabilization muscles. The control group followed a standard postoperative protocol, where no exercises were performed at that stage of rehabilitation. Functional outcomes and plain radiographs were evaluated at 3 weeks and subsequently at 3 and 18 months after the surgery.
Results
No hardware loosening of failure was observed in the training group. Both groups improved their walking speed after 3 months (
p
< 0.01), although improvement in the training group was significantly greater than in the control group (
p
< 0.01). Moreover, the training group significantly improved after the training period in all isometric trunk muscles measurements (
p
< 0.03), standing reach height (
p
< 0.02), and pre-activation pattern (
p
< 0.05). After 18 months, no training effects were observed.
Conclusions
The study showed that early initiation of a postoperative rehabilitation program based on principles of strength training is safe, 3 weeks after lumbar spine fusion, and enable earlier functional recovery than standard rehabilitation protocol.
Trial registration
The study is registered at the US National Institutes of Health (
ClinicalTrials.gov
)
NCT03349580
. The date of registration: November 21, 2017 - Retrospectively registered.
Journal Article
Prehabilitation and early rehabilitation after spinal surgery: randomized clinical trial
2010
Objective: To evaluate the outcome after spinal surgery when adding prehabilitation to the early rehabilitation.
Design: A randomized clinical study.
Setting: Orthopaedic surgery department.
Subject: Sixty patients scheduled for surgery followed by inpatient rehabilitation for degenerative lumbar disease.
Interventions: The patients were computer randomized to prehabilitation and early rehabilitation (28 patients) or to standard care exclusively (32 patients). The intervention began two months prior to the operation. The prehabilitation included an intensive exercise programme and optimization of the analgesic treatment. Protein drinks were given the day before surgery. The early postoperative rehabilitation included balanced pain therapy with self-administered epidural analgesia, doubled intensified mobilization and protein supplements.
Main measures: The outcome measurements were postoperative stay, complications, functionality, pain and satisfaction.
Results: At operation the intervention group had improved function, assessed by Roland Morris Questionnaire (P = 0.001). After surgery the intervention group reached the recovery milestones faster than the control group (1—6 days versus 3—13, P =0.001), and left hospital earlier (5 (3—9) versus 7 (5—15) days, P =0.007). There was no difference in postoperative complications, adverse events, low back pain and radiating pain, timed up and go, sit-to-stand or in life quality. Patient satisfaction was significantly higher in the intervention group compared with the control group.
Conclusion: The integrated programme of prehabilitation and early rehabilitation improved the outcome and shortened the hospital stay — without more complications, pain or dissatisfaction.
Journal Article
An analysis of fusion cage migration in unilateral and bilateral fixation with transforaminal lumbar interbody fusion
2013
Purpose
To investigate if instrumentation (unilateral vs. bilateral fixation) has an effect on the rate of fusion cage migration.
Methods
This clinical study of transforaminal lumbar interbody fusion involved a prospective group of 116 patients who were randomly assigned to either unilateral (
n
= 57) or bilateral (
n
= 59) fixation. Fourteen were lost to follow-up (11 from the unilateral group and 3 from the bilateral group).
Results
The unilateral fixation group consisted of 20 male and 26 female patients. In the unilateral group, the mean age was 53.5 years (range, 18–77), and the preoperative diagnosis consisted of degenerative disc disease, with or without herniated disc (
n
= 44), and degenerative spondylolisthesis with spinal stenosis (
n
= 2). The bilateral fixation group consisted of 20 male and 36 female patients. In the bilateral group, the mean age was 55.7 years (range, 26–82), and the preoperative diagnosis consisted of degenerative disc disease, with or without herniated disc (
n
= 40), and degenerative spondylolisthesis with spinal stenosis (
n
= 16). A total of 17 cases of cage migration were found; of these, 11 were from the unilateral group and 6 from the bilateral group, resulting in rates of cage migration of 23 and 11 % (
p
= 0.03), respectively. In regard to migration cases, 5 were male and 12 were female. Ages ranged from 27 to 79 years (mean age, 55 years).
Conclusion
We conclude that unilateral fixation is not stable enough to prevent fusion cage migration in some patients who undergo TLIF.
Journal Article
Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial
by
Turner, Judith A
,
Johnston, Sandra K
,
Deyo, Richard A
in
Bone surgery
,
Care and treatment
,
Decompression
2021
Abstract
Objective
To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints.
Design
Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic stepped-wedge randomized trial.
Setting
Primary care clinics within four integrated health care systems in the United States.
Subjects
238,886 patients ≥18 years of age who received lumbar diagnostic imaging between 2013 and 2016.
Methods
Clinics were randomized to receive text containing age- and modality-specific epidemiological benchmarks indicating the prevalence of common spine imaging findings in people without low back pain, inserted into lumbar spine imaging reports (the “LIRE intervention”). The study outcomes were receiving 1) any nonsurgical lumbosacral or sacroiliac spine procedure (lumbosacral epidural steroid injection, facet joint injection, or facet joint radiofrequency ablation; or sacroiliac joint injection) or 2) any surgical procedure involving the lumbar, sacral, or thoracic spine (decompression surgery or spinal fusion or other spine surgery).
Results
The LIRE intervention was not significantly associated with subsequent utilization of nonsurgical lumbosacral or sacroiliac spine procedures (odds ratio [OR] = 1.01, 95% confidence interval [CI] 0.93–1.09; P = 0.79) or any surgical procedure (OR = 0.99, 95 CI 0.91–1.07; P = 0.74) involving the lumbar, sacral, or thoracic spine. The intervention was also not significantly associated with any individual spine procedure.
Conclusions
Inserting epidemiological text into spine imaging reports had no effect on nonsurgical or surgical procedure utilization among patients receiving lumbar diagnostic imaging.
Journal Article
Unilateral biportal endoscopic decompression versus anterior cervical decompression and fusion for unilateral cervical radiculopathy or coexisting cervical myelopathy: a prospective, randomized, controlled, noninferiority trial
by
Chu, Rupeng
,
Cui, Wei
,
Han, Xiaofei
in
Adult
,
Aged
,
Anterior cervical decompression and fusion
2024
Background
Cervical spondylosis (CS), including myelopathy and radiculopathy, is the most common degenerative cervical spine disease. This study aims to evaluate the clinical outcomes of unilateral biportal endoscopy (UBE) compared to those of conventional anterior cervical decompression and fusion (ACDF) for treating unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs.
Methods
A prospective, randomized, controlled, noninferiority trial was conducted. The sample consisted of 131 patients who underwent UBE or ACDF was conducted between September 2021 and September 2022. Patients with cervical nerve roots or coexisting spinal cord compression symptoms and imaging-defined unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs were randomized into two groups: a UBE group (
n
= 63) and an ACDF group (
n
= 68). The operative time, blood loss, length of hospital stay after surgery, and perioperative complications were recorded. Preoperative and postoperative modified Japanese Orthopaedic Association (mJOA) scale scores, visual analog scale (VAS) scores, neck disability index (NDI) scores, and recovery rate (RR) of the mJOA were utilized to evaluate clinical outcomes.
Results
The hospital stay after surgery was significantly shorter in patients treated with UBE than in those treated with ACDF (
p
< 0.05). There were no significant differences in the neck or arm VAS score, NDI score, mJOA score, or mean RR of the mJOA between the two groups (
p
< 0.05). Only mild complications were observed in both groups, with no significant difference (
p
= 0.30).
Conclusion
UBE can significantly relieve pain and disability without severe complications, and most patients are satisfied with this technique. Consequently, this procedure can be used safely and effectively as an alternative to ACDF for treating unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs.
Trial registration
This study was registered in the Chinese Clinical Trial Registry on 02/08/2023 (
http://www.chictr.org.cn
, #ChiCTR2300074273).
Journal Article
Rehabilitation following lumbar fusion surgery (REFS) a randomised controlled feasibility study
by
McGregor, Alison
,
Jones, Fiona
,
Greenwood, James
in
Anxiety
,
Body mass index
,
Feasibility studies
2019
PurposeFollowing lumbar fusion surgery (LFS), 40% of patients are unsure/dissatisfied with their outcome. A prospective, single-centre, randomised, controlled trial was conducted to evaluate the feasibility (including clinical and economic impact) of a theoretically informed rehabilitation programme following LFS (REFS).MethodsREFS was informed by an explicit theoretical framework and consisted of 10 consecutive weekly group rehabilitation sessions (education, low-tech cardiovascular, limb and spine strengthening exercises, and peer support). Participants were randomised to REFS or ‘usual care.’ Primary feasibility outcomes included recruitment and engagement. Secondary outcomes, collected preoperatively and 3, 6, and 12 months postoperatively, comprised the Oswestry disability index, European Quality of Life 5 dimensions score, pain self-efficacy questionnaire, hospital anxiety and depression scale and the aggregated functional performance time. Economic impact was evaluated with the Client Services Receipt Inventory.ResultsFifty-two of 58 eligible participants were recruited, and engagement with REFS was > 95%. REFS participants achieved a clinically meaningful reduction in unadjusted mean short-term disability (− 13.27 ± 13.46), which was not observed in the ‘usual care’ group (− 2.42 ± 12.33). This was maintained in the longer term (− 14.72% ± 13.34 vs − 7.57 ± 13.91). Multilevel regression analyses, adjusted for body mass index, baseline depression, and smoking status reported a statistically significant short-term improvement in disability (p = 0.014) and pain self-efficacy (p = 0.007). REFS costs £275 per participant.ConclusionsResults suggest that REFS is feasible and potentially affordable for delivery in the National Health Service. It is associated with a clinically meaningful impact. A multicentre randomised controlled study to further elucidate these results is warranted.Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.
Journal Article
Hidden and overall haemorrhage following minimally invasive and open transforaminal lumbar interbody fusion
2017
Background
Hidden haemorrhage has been proved to be significant in joint surgery. However, when referring to lumbar interbody fusion, it is often ignored because of its invisibility. This randomized controlled study aimed to calculate and compare hidden haemorrhage following minimally invasive and open transforaminal lumbar interbody fusion (MIS-TLIF and open TLIF). Meanwhile, its clinical significance was also analyzed.
Materials and methods
A total of 41 patients were included in this study, then they were randomized to receive MIS-TLIF or open TLIF, 21 and 20, respectively. For each case, total volume loss of red blood cell (RBC) was calculated by Gross' formula based on perioperative haematocrit change, then perioperative visible volume loss of RBC was calculated through haemorrhage volume and weight. After deducting it from total volume loss of RBC, hidden volume loss of RBC was obtained. Absolute amount of hidden haemorrhage and its ratio upon total haemorrhage, as well as indicators assessing clinical outcomes, including visual analogue scale (VAS) for back and leg, Oswestry disability index (ODI), interbody fusion rate and complication incidence were compared and analyzed.
Results
Mean hidden volume loss of RBC in MIS-TLIF was significantly reduced compared with open TLIF (166.7 versus 245.6 ml). Besides, both mean total and visible volume loss of RBC in MIS-TLIF were also statistically less than those in open TLIF (355.3 versus 538.6 ml; 188.6 versus 293.0 ml). While mean ratio of hidden haemorrhage upon total haemorrhage was 46.7% for MIS-TLIF and 44.5% for open TLIF, respectively, showing no statistical significance. At one week postoperatively, more significant improvements of VAS for back and leg, as well as ODI were seen in MIS-TLIF compared with open TLIF. While at final follow-up of at least 2 years, all parameters continued to improve and revealed no statistical difference between both surgeries. Similar interbody fusion rate and complication incidence were observed in both series.
Conclusions
Besides reduced visible haemorrhage and improved clinical outcomes, MIS-TLIF also owns the superiority of less hidden haemorrhage, offering another advantage over open TLIF.
Level of evidence
Level II.
Journal Article