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1.

Background Context

Transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) are both frequently used as a surgical treatment for lumbar spondylolisthesis. Because of the unilateral transforaminal route to the intervertebral space used in TLIF, as opposed to the bilateral route used in PLIF, TLIF could be associated with fewer complications, shorter duration of surgery, and less blood loss, whereas the effectiveness of both techniques on back or leg pain is equal.

Purpose

The objective of this study was to compare the effectiveness of both TLIF and PLIF in reducing disability, and to compare the intra- and postoperative complications of both techniques in patients with lumbar spondylolisthesis.

Study Design/Setting

A systematic literature review and meta-analysis were carried out.

Methods

We conducted a Medline (using PubMed), Embase (using Ovid), Cochrane Library, Current Controlled Trials, ClinicalTrials.gov and NHS Centre for Review and Dissemination search for studies reporting TLIF, PLIF, lumbar spondylolisthesis and disability, pain, complications, duration of surgery, and estimated blood loss. A meta-analysis was performed to compute pooled estimates of the differences between TLIF and PLIF. Forest plots were constructed for each analysis group.

Results

A total of 192 studies were identified; nine studies were included (one randomized controlled trial and eight case series), including 990 patients (450 TLIF and 540 PLIF). The pooled mean difference in postoperative Oswestry Disability Index (ODI) scores between TLIF and PLIF was ?3.46 (95% confidence interval [CI] ?4.72 to ?2.20, p≤.001). The pooled mean difference in the postoperative VAS scores was ?0.05 (95% CI ?0.18 to 0.09, p=.480). The overall complication rate was 8.7% (range 0%–25%) for TLIF and 17.0% (range 4.7–28.8%) for PLIF; the pooled odds ratio was 0.47 (95% CI 0.28–0.81, p=.006). The average duration of surgery was 169 minutes for TLIF and 190 minutes for PLIF (mean difference ?20.1, 95% CI ?33.5 to ?6.6, p=.003). The estimated blood loss was 350?mL for TLIF and 418?mL for PLIF (mean difference ?43.9?mL, 95% CI ?71.2 to ?16.6, p=.002).

Conclusions

TLIF has advantages over PLIF in the complication rate, blood loss, and operation duration. The clinical outcome is similar, with a slightly lower postoperative ODI score for TLIF.  相似文献   

2.

Background Context

To date, the surgical approaches for the treatment of lumbar spondylolisthesis by transforaminal lumbar interbody fusion (TLIF) using minimally invasive spine surgery assisted with intraoperative computed tomography image-integrated navigation (MISS-iCT), fluoroscopy (MISS-FS), and conventional open surgery (OS) are debatable.

Purpose

This study compared TLIF using MISS-iCT, MISS-FS, and OS for treatment of one-level lumbar spondylolisthesis.

Study Design

This is a prospective, registry-based cohort study that compared surgical approaches for patients who underwent surgical treatment for one-level lumbar spondylolisthesis.

Patient Sample

One hundred twenty-four patients from January 2010 to March 2012 in a medical center were recruited.

Outcome Measures

The outcome measures were clinical assessments, including Short-Form 12, visual analog scale (VAS), Oswestry Disability Index, Core Outcome Measurement Index, and patient satisfaction, and blood loss, hospital stay, operation time, postoperative pedicle screw accuracy, and superior-level facet violation.

Methods

All surgeries were performed by two senior surgeons together. Ninety-nine patients (40M, 59F) who had at least 2 years' follow-up were divided into three groups according to the operation methods: MISS-iCT (N=24), MISS-FS (N=23), and OS (N=52) groups. Charts and surgical records along with postoperative CT images were assessed.

Results

MISS-iCT and MISS-FS demonstrated a significantly lowered blood loss and hospital stay compared with OS group (p<.01). Operation time was significantly lower in the MISS-iCT and OS groups compared with the MISS-FS group (p=.002). Postoperatively, VAS scores at 1 year and 2 years were significantly improved in the MISS-iCT and MISS-FS groups compared with the OS groups. No significant difference in the number of pedicle screw breach (>2?mm) was found. However, a lower superior-level facet violation rate was observed in the MISS-iCT and OS groups (p=.049).

Conclusions

MISS-iCT TLIF demonstrated reduced operation time, blood loss, superior-level facet violation, hospital stay, and improved functional outcomes compared with the MISS-FS and OS approaches.  相似文献   

3.

Background Context

The oblique lateral interbody fusion (OLIF) procedure is aimed at mitigating some of the challenges seen with traditional anterior lumbar interbody fusion (ALIF) and transpsoas lateral lumbar interbody fusion (LLIF), and allows for interbody fusion at L1–S1.

Purpose

The study aimed to describe the OLIF technique and assess the complication and fusion rates.

Study Design

This is a retrospective cohort study.

Patient Sample

The sample is composed of 137 patients who underwent OLIF procedure.

Outcome Measures

The outcome measures were adverse events within 6 months of surgery: infection, symptomatic pseudarthrosis, hardware failure, vascular injury, perioperative blood transfusion, ureteral injury, bowel injury, renal injury, prolonged postoperative ileus (more than 3 days), incisional hernia, pseudohernia, reoperation, neurologic deficits (weakness, numbness, paresthesia), hip flexion pain, retrograde ejaculation, sympathectomy affecting lower extremities, deep vein thrombosis, pulmonary embolism, myocardial infarction, pneumonia, and cerebrovascular accident. The outcome measures also include fusion and subsidence rates based on computed tomography (CT) done at 6 months postoperatively.

Methods

Retrospective chart review of 150 consecutive patients was performed to examine the complications associated with OLIF at L1–L5 (OLIF25), OLIF at L5–S1 (OLIF51), and OLIF at L1–L5 combined with OLIF at L5–S1 (OLIF25+OLIF51). Only patients who had at least 6 months of postoperative follow-up, including CT scan at 6 months after surgery, were included. Independent radiology review of CT data was performed to assess fusion and subsidence rates at 6 months.

Results

A total of 137 patients underwent fusion at 340 levels. An overall complication rate of 11.7% was seen. The most common complications were subsidence (4.4%), postoperative ileus (2.9%), and vascular injury (2.9%). Ileus and vascular injuries were only seen in cases including OLIF51. No patient suffered neurologic injury. No cases of ureteral injury, sympathectomy affecting the lower extremities, or visceral injury were seen. Successful fusion was seen at 97.9% of surgical levels.

Conclusions

Oblique lateral interbody fusion is a safe procedure at L1–L5 as well as L5–S1. The complication profile appears acceptable when compared with LLIF and ALIF. The oblique trajectory mitigates psoas muscle and lumbosacral plexus-related complications seen with the lateral transpsoas approach. Furthermore, there is a high fusion rate based on CT data at 6 months.  相似文献   

4.

Background Context

Although minimally invasive surgery (MIS)-transforaminal lumbar interbody fusion (TLIF) has many evidence-based short-term benefits over open TLIF, both procedures have similar long-term outcomes. Patients' preference for MIS over open TLIF may be confounded by a lack of understanding of what each approach entails.

Purpose

The study aimed to identify the various factors influencing patients' choice between MIS and open TLIF.

Study Design/Setting

This is a cross-sectional study conducted at a tertiary health-care institution.

Patient Sample

Patients, for whom TLIF procedures were indicated, were recruited over a 3-month period from specialist outpatient clinics.

Outcome Measure

The outcome measure was patients' choice of surgical approach (MIS or open).

Methods

All patients were subjected to a stepwise interviewing process and were asked to select between open and MIS approaches at each step. Further subgroup analysis stratifying subjects based on stages of decision-making was performed to identify key predictors of selection changes. No sources of funding were required for this study and there are no conflicts of interests.

Results

Fifty-four patients with a mean age of 55.8 years participated in the study. Thirteen (24.1%) consistently selected a single approach, whereas 31 (57.4%) changed their selection more than once during the interviewing process. Overall, 12 patients (22.2%) had a final decision different from their initial choice, and 15 patients (27.8%) were unable to decide. A large proportion of patients (65.0%) initially favored the open approach's midline incision. This proportion dropped to 16.7% (p<.001) upon mention of the term MIS. The proportion of patients favoring MIS dropped significantly following discussion on the pros and cons (p=.002) of each approach, as well as conversion or revision surgery (p=.017). Radiation and cosmesis were identified as the two most important factors influencing patients' final decisions.

Conclusions

The longer midline incision of the open approach is cosmetically more appealing to patients than the paramedian stab wounds of MIS. The advantages of the MIS approach may not be as valued by patients as they are by surgeons. Given the equivalent long-term outcomes of both approaches, it is crucial that patients are adequately informed during preoperative counseling to achieve the best consensus decision.  相似文献   

5.

Background Context

Surgical treatment of symptomatic adjacent segment disease (ASD) typically involves extension of previous instrumentation to include the newly affected level(s). Disruption of the incision site can present challenges and increases the risk of complication. Lateral-based interbody fusion techniques may provide a viable surgical alternative that avoids these risks. This study is the first to analyze the biomechanical effect of adding a lateral-based construct to an existing fusion.

Purpose

The study aimed to determine whether a minimally invasive lateral interbody device, with and without supplemental instrumentation, can effectively stabilize the rostral segment adjacent to a two-level fusion when compared with a traditional posterior revision approach.

Study Design/Setting

This is a cadaveric biomechanical study of lateral-based interbody strategies as add-on techniques to an existing fusion for the treatment of ASD.

Methods

Twelve lumbosacral specimens were non-destructively loaded in flexion, extension, lateral bending, and torsion. Sequentially, the tested conditions were intact, two-level transforaminal lumbar interbody fusion (TLIF) (L3–L5), followed by lateral lumbar interbody fusion procedures at L2–L3 including interbody alone, a supplemental lateral plate, a supplemental spinous process plate, and then either cortical screw or pedicle screw fixation. A three-level TLIF was the final instrumented condition. In all conditions, three-dimensional kinematics were tracked and range of motion (ROM) was calculated for comparisons. Institutional funds (<$50,000) in support of this work were provided by Medtronic Spine.

Results

The addition of a lateral interbody device superadjacent to a two-level fusion significantly reduced motion in flexion, extension, and lateral bending (p<.05). Supplementing with a lateral plate further reduced ROM during lateral bending and torsion, whereas a spinous process plate further reduced ROM during flexion and extension. The addition of posterior cortical screws provided the most stable lateral lumbar interbody fusion construct, demonstrating ROM comparable with a traditional three-level TLIF.

Conclusions

The data presented suggest that a lateral-based interbody fusion supplemented with additional minimally invasive instrumentation may provide comparable stability with a traditional posterior revision approach without removal of the existing two-level rod in an ASD revision scenario.  相似文献   

6.

Background Context

Prior studies have suggested no significant differences in functional status and postoperative complications of elderly versus nonelderly patients undergoing posterior lumbar interbody fusion; however, similar studies have not been comprehensively investigated in the setting of anterior lumbar interbody fusion (ALIF).

Purpose

The objective was to quantify the ability of the modified Frailty Index (mFI) to predict postoperative events in patients undergoing ALIF.

Study Design

Secondary analysis of prospectively collected data.

Patient Sample

Patients undergoing ALIF in the National Surgical Quality Improvement Program (NSQIP) participant files for the period 2010 through 2014.

Outcomes Measures

Outcome measures included any postoperative complication, return to operating room (OR), and length of stay >5 days.

Methods

NSQIP participant files from 2010 to 2014 were used to identify patients undergoing ALIF. The mFI used in the present study is an 11-variable assessment that maps 16 NSQIP variables to 11 variables in the Canadian Study of Health and Ageing Frailty Index. Univariate analysis and multivariable logistic regression models were used to compare the relative strength of association between mFI with outcome variables of interest.

Results

In total, 3,920 ALIF cases were identified and grouped according to their mFI score: 0 (n=2,025), 0.09 (n=1,382), 0.18 (n=464), or ≥0.27 (n=49). As the mFI increased from 0 (no frailty-associated variables) to 0.27 (4 of 11) or higher, there was a significant stepwise increase in any complication from 10.8% to 32.7%. After multivariable regression analysis, no significant association was found between higher mFI scores with urinary tract infections and venous thromboembolism. High frailty scores were significant predictors of any complication (mFI of ≥0.27 [reference: 0]; OR 2.4; p=.040) and pulmonary complications (mFI score ≥0.27; OR 7.5; p=.001).

Conclusions

In summary, high mFI scores were found to be independently associated with any complication and pulmonary complications in patients who underwent ALIF. The use of mFI together with traditional risk factors may help better identify high-surgical risk patients, which may be useful for preoperative and postoperative care optimization.  相似文献   

7.

Background Context

There have been conflicting results on the surgical outcome of lumbar fusion surgery using two different techniques: robot-assisted pedicle screw fixation and conventional freehand technique. In addition, there have been no studies about the biomechanical issues between both techniques.

Purpose

This study aimed to investigate the biomechanical properties in terms of stress at adjacent segments using robot-assisted pedicle screw insertion technique (robot-assisted, minimally invasive posterior lumbar interbody fusion, Rom-PLIF) and freehand technique (conventional, freehand, open approach, posterior lumbar interbody fusion, Cop-PLIF) for instrumented lumbar fusion surgery.

Study Design

This is an additional post-hoc analysis for patient-specific finite element (FE) model.

Patient Sample

The sample is composed of patients with degenerative lumbar disease.

Outcome Measures

Intradiscal pressure and facet contact force are the outcome measures.

Methods

Patients were randomly assigned to undergo an instrumented PLIF procedure using a Rom-PLIF (37 patients) or a Cop-PLIF (41), respectively. Five patients in each group were selected using a simple random sampling method after operation, and 10 preoperative and postoperative lumbar spines were modeled from preoperative high-resolution computed tomography of 10 patients using the same method for a validated lumbar spine model. Under four pure moments of 7.5?Nm, the changes in intradiscal pressure and facet joint contact force at the proximal adjacent segment following fusion surgery were analyzed and compared with preoperative states.

Results

The representativeness of random samples was verified. Both groups showed significant increases in postoperative intradiscal pressure at the proximal adjacent segment under four moments, compared with the preoperative state. The Cop-PLIF models demonstrated significantly higher percent increments of intradiscal pressure at proximal adjacent segments under extension, lateral bending, and torsion moments than the Rom-PLIF models (p=.032, p=.008, and p=.016, respectively). Furthermore, the percent increment of facet contact force was significantly higher in the Cop-PLIF models under extension and torsion moments than in the Rom-PLIF models (p=.016 under both extension and torsion moments).

Conclusions

The present study showed the clinical application of subject-specific FE analysis in the spine. Even though there was biomechanical superiority of the robot-assisted insertions in terms of alleviation of stress increments at adjacent segments after fusion, cautious interpretation is needed because of the small sample size.  相似文献   

8.

Background Context

Lateral lumbar interbody fusion (LLIF) is a frequently used technique for the treatment of lumbar pathology. Despite its overall success, LLIF has been associated with a unique set of complications. However, there has been inconsistent evidence regarding the complication rate of this approach.

Purpose

To perform a systematic review analyzing the rates of medical and surgical complications associated with LLIF.

Study Design

Systematic review.

Patient Sample

6,819 patients who underwent LLIF reported in clinical studies through June 2016.

Outcome Measures

Frequency of complications within cardiac, vascular, pulmonary, urologic, gastrointestinal, transient neurologic, persistent neurologic, and spine (MSK) categories.

Methods

This systematic review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Relevant studies that identified rates of any complication following LLIF procedures were obtained from PubMed, MEDLINE, and EMBASE databases. Articles were excluded if they did not report complications, presented mixed complication data from other procedures, or were characterized as single case reports, reviews, or case series containing less than 10 patients. The primary outcome was frequency of complications within cardiac, vascular, pulmonary, urologic, gastrointestinal, transient neurologic, persistent neurologic, and MSK categories. All rates of complications were based on the sample sizes of studies that mentioned the respective complications. The authors report no conflicts of interest directly or indirectly related to this work, and have not received any funds in support of this work.

Results

A total of 2,232 articles were identified. Following screening of title, abstract, and full-text availability, 63 articles were included in the review. A total of 6,819 patients had 11,325 levels fused. The rate of complications for the categories included were as follows: wound (1.38%; 95% confidence interval [CI]=1.00%–1.85%), cardiac (1.86%; CI=1.33%–2.52%), vascular (0.81%; CI=0.44%–1.36%), pulmonary (1.47; CI=0.95%–2.16%), gastrointestinal (1.38%; CI=1.00%–1.87%), urologic (0.93%; CI=0.55%–1.47%), transient neurologic (36.07%; CI=34.74%–37.41%), persistent neurologic (3.98%; CI=3.42%–4.60%), and MSK or spine (9.22%; CI=8.28%–10.23%).

Conclusions

The current study is the first to comprehensively analyze the complication profile for LLIFs. The most significant reported complications were transient neurologic in nature. However, persistent neurologic complications occurred at a much lower rate, bringing into question the significance of transient symptoms beyond the immediate postoperative period. Through this analysis of complication profiles, surgeons can better understand the risks to and expectations for patients following LLIF procedures.  相似文献   

9.

Background Context

Sagittal imbalance is associated with poor clinical outcomes in patients with degenerative lumbar disease. However, there is no consensus on the impact of posterior lumbar interbody fusion (PLIF) on local and global sagittal balance.

Purpose

To reveal the effect of one- or two-level PLIF on global sagittal balance.

Design/Setting

A retrospective case-control study.

Patients Sample

This study included 88 patients who underwent a one- or two-level PLIF for spinal stenosis with spondylolisthesis.

Outcome Measures

Clinical and radiological parameters were measured pre- and postoperatively.

Methods

All patients were followed up for >2 years. Clinical outcomes included a visual analog scale, Oswestry Disability Index, and EuroQol 5-dimension questionnaire (EQ-5D). Radiological parameters were measured using whole-spine standing lateral radiographs. Fusion, loosening, subsidence rates, and adverse events were also evaluated. Patients were divided into two groups according to their preoperative C7–S1 sagittal vertical axis (SVA): Group N: SVA≤5?cm vs Group I: SVA>5?cm; they were also divided according to postoperative changes in C7–S1 SVA. Clinical and radiological outcomes were compared between the groups.

Results

All clinical outcomes and radiological parameters improved postoperatively. C7–S1 SVA improved (?1.6?cm) after L3–L5 fusion, but it was compromised (+3.6?cm) after L4–S1 fusion (p=.001). Preoperative demographic and clinical data showed no difference except in the anxiety or depression domain of EQ-5D. No differences were found in postoperative clinical outcomes. Lumbar lordosis, pelvic tilt, and thoracic kyphosis slightly improved in Group N, whereas C7–S1 SVA decreased from 9.5?cm to 3.8?cm (p<.001) in Group I. Furthermore, all sagittal parameters improved in Group I. On comparing the postoperative changes in C7–S1 SVA, we found that the decreasing trend in the postoperative C7–S1 SVA was related to a larger preoperative C7–S1 SVA (p=.030) and a more proximal level fusion (L3–L5 vs L4–S1, p=.033).

Conclusions

Global sagittal balance improved after short-level lumbar fusion surgery in patients having spinal stenosis with spondylolisthesis who showed preoperative sagittal imbalance. Restoration of sagittal balance predominantly occurred after L3–L4, L4–L5, or L3–L5 PLIF. However, no such restoration was observed after L5–S1 or L4–S1 PLIF. Thus, we could anticipate sagittal balance restoration after performing PLIF at L3–L4 or L4–L5 level. However, caution is required when planning for L5–S1 fusion if preoperative sagittal imbalance is present.  相似文献   

10.

Background Context

Multiple studies have determined minimum clinically important difference (MCID) thresholds for EuroQOL-5 Dimensions (EQ-5D) scores in lumbar fusion patients. However, a comprehensive understanding of predictors for a clinically significant improvement (CSI) postoperatively does not exist.

Purpose

To determine medical, radiographic, and surgical predictors for obtaining a CSI following lumbar fusion surgery.

Study Design

This is a retrospective review of patients who underwent instrumented lumbar fusion.

Patient Sample

We included patients who underwent lumbar fusion for any indication between 2008 and 2013.

Outcome Measures

Outcome measures included preoperative and postoperative EQ-5D Index scores.

Materials and Methods

The medical records of patients who received a lumbar fusion for any indication were retrospectively reviewed to identify patient medical and surgical characteristics. A blinded reviewer assessed radiographs for each patient to examine sagittal alignment following fusion. Multivariable logistic regression was used to model the achievement of a CSI based on two commonly cited MCID values.

Results

A total of 231 patients fit the inclusion criteria; 58% exceeded an MCID value for an EQ-5D score of 0.100, and 16% exceeded an MCID value of 0.390. Statistically significant independent predictors of not obtaining a CSI for an MCID threshold of 0.100 included a higher preoperative EQ-5D score (odds ratio [OR]=44.8) and L5-S1 fusion (OR=3.3). For an MCID value of 0.390, a higher preoperative EQ-5D score (OR=2,080.8) and a diagnosis of depression (OR=7.1) were predictive of not achieving a CSI, whereas spondylolisthesis (OR=4.1) was predictive of obtaining a CSI postoperatively. For both MCID values, patients who achieved a CSI had better postoperative quality of life (QOL) scores for all metrics measured, despite worse QOL scores preoperatively.

Conclusions

This study is the first to use a combination of medical, surgical, and postoperative sagittal balance variables as determinants for the achievement of a CSI after lumbar fusion. The awareness of these predictors may allow for better patient selection and surgical approach to decrease the probability of acquiring a poor outcome postoperatively.  相似文献   

11.

Background Context

Elective spine surgery is a commonly performed operative procedure, that requires knowledge of risk-adjusted results to improve outcomes and reduce costs.

Purpose

To develop risk-adjusted models to predict the adverse outcomes (AOs) of care during the inpatient and 90-day post-discharge period for spine fusion surgery.

Study Design/Setting

To identify the significant risk factors associated with AOs and to develop risk models that measure performance.

Patient Sample

Hospitals that met minimum criteria of both 20 elective cervical and 20 elective non-cervical spine fusion operations in the 2012–2014 Medicare limited dataset.

Outcome Measures

The risk-adjusted AOs of inpatient deaths, prolonged length-of-stay for the index hospitalization, 90-day post-discharge deaths, and 90-day post-discharge readmissions were dependent variables in predictive risk models.

Methods

Over 500 candidate risk factors were used for logistic regression models to predict the AOs. Models were then used to predicted risk-adjusted AO rates by hospitals.

Results

There were 874 hospitals with a minimum of both 20 cervical and 20 non-cervical spine fusion patients. There were 167,395 total cases. A total of 7,981 (15.9%) of cervical fusion patients and 17,481 (14.9%) of non-cervical fusion patients had one or more AOs for an overall AO rate of 15.2%. A total of 54 hospitals (6.2%) had z-scores that were 2.0 better than predicted with a median risk adjusted AO rate of 9.2%, and 75 hospitals (8.6%) were 2.0 z-scores poorer than predicted with a median risk-adjusted AO rate of 23.2%.

Conclusions

Differences among hospitals defines opportunities for care improvement.  相似文献   

12.

Background Context

Lumbar fusion is a common and costly procedure in the United States. Reimbursement for surgical procedures is increasingly tied to care quality and patient safety as part of value-based reimbursement programs. The incidence of adverse quality events among lumbar fusion patients is unknown using the definition of care quality (patient safety indicators [PSI]) used by the Centers for Medicare and Medicaid Services (CMS). The association between insurance status and the incidence of PSI is similarly unknown in lumbar fusion patients.

Purpose

This study sought to determine the incidence of PSI in patients undergoing inpatient lumbar fusion and to quantify the association between primary payer status and PSI in this population.

Study Design

A retrospective cohort study was carried out.

Patient Sample

The sample comprised all adult patients aged 18 years and older who were included in the Nationwide Inpatient Sample (NIS) that underwent lumbar fusion from 1998 to 2011.

Outcome Measure

The incidence of one or more PSI, a validated and widely used metric of inpatient health-care quality and patient safety, was the primary outcome variable.

Methods

The NIS data were examined for all cases of inpatient lumbar fusion from 1998 to 2011. The incidence of adverse patient safety events (PSI) was determined using publicly available lists of the International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. Logistic regression models were used to determine the association between primary payer status (Medicaid and self-pay relative to private insurance) and the incidence of PSI.

Results

A total of 539,172 adult lumbar fusion procedures were recorded in the NIS from 1998 to 2011. Patients were excluded from the secondary analysis if “other” or “missing” was listed for primary insurance status. The national incidence of PSI was calculated to be 2,445 per 100,000 patient years of observation, or approximately 2.5%. In a secondary analysis, after adjusting for patient demographics and hospital characteristics, Medicaid and self-pay patients had significantly greater odds of experiencing one or more PSI during the inpatient episode relative to privately insured patients (odds ratio 1.16, 95% confidence interval 1.07–1.27).

Conclusions

Among patients undergoing inpatient lumbar fusion, insurance status is associated with the adverse health-care quality events used to determine hospital reimbursement by the CMS. The source of this disparity must be studied to improve the quality of care delivered to vulnerable patient populations.  相似文献   

13.

Background Context

Understanding the influence of preoperative diagnosis on outcomes for lumbar fusion surgery improves the quality of research and outcomes data, and helps guide treatment decisions.

Purpose

We sought to perform a systematic review of the literature published between 2000 and 2014 regarding lumbar fusion outcomes for degenerative disorders. An assessment of the influence of subgroup diagnosis on outcomes as well as the quality of this body of literature was performed.

Study Design

Systematic review

Patient Sample

The 100 studies ultimately included involved adult patients (n=8,706) undergoing fusion surgery for degenerative disorders of the lumbar spine.

Outcome Measures

Visual analog scale (VAS) pain scores, complication rates, and determination of successful fusion

Methods

With adherence to the PRISMA guidelines, electronic searches were performed through PubMed, Scopus, and Web of Science to identify all studies involving lumbar fusion for degenerative disc disorders from January 2000 to August 2014. Studies were eligible for inclusion if they addressed adult patients treated with lumbar fusion for one of the following: stable degenerative disc disease, unstable degenerative disc disease, degenerative disc disease not specified (DDDns), herniated disc (DH), degenerative spondylolisthesis (DDDsp), and adult degenerative scoliosis (DDDsc). Abstracted data included the number of patients, preoperative diagnosis, fusion technique, complications, fusion rate, and clinical outcomes.

Results

One hundred articles met inclusion criteria and yielded data for 8,706 patients. Forty-three studies included data for clinical improvement (VAS scores). The mean clinical improvement in VAS scores was significantly different among the diagnoses (p<.001), with DDDsp demonstrating the highest improvement (60%) and DDDns having the lowest (45%). Eighty-five studies included data for complication rates. Complication rates differed significantly (p<.001), with the highest rate seen in the DDDsc group (18%), followed by DDDsp (14%). Seventy-eight studies included data for fusion. The pooled odds of fusion for prospective studies were 6.93 (95% CI 4.75, 10.13). There was no evidence of publication bias.

Conclusions

A relationship between outcomes and subgroup diagnosis was demonstrated. This review demonstrated a higher quality of evidence in the literature, and greater overall fusion rates compared to similar studies published in the 1980s and 1990s.  相似文献   

14.

Background Context

Proper patient selection is of utmost importance in the surgical treatment of degenerative disc disease (DDD) with chronic low back pain (CLBP). Among other factors, gender was previously found to influence lumbar fusion surgery outcome.

Purpose

This study investigates whether gender affects clinical outcome after lumbar fusion.

Study Design

This is a national registry cohort study.

Patient sample

Between 2001 and 2011, 2,251 men and 2,521 women were followed prospectively within the Swedish National Spine Register (SWESPINE) after lumbar fusion surgery for DDD and CLBP.

Outcome measures

Patient-reported outcome measures (PROMs), visual analog scale (VAS) for leg and back pain, Oswestry Disability Index (ODI), quality of life (QoL) parameter EQ5D, and labor status and pain medication were collected preoperatively, 1 and 2 years after surgery.

Methods

Gender differences of baseline data and PROM improvement from baseline were analyzed. The effect of gender on clinically important improvement of PROM was determined in a multivariate logistic regression model. Furthermore, gender-related differences in return-to-work were investigated.

Results

Preoperatively, women had worse leg pain (p<.001), back pain (p=.002), lower QoL (p<.001), and greater disability than men (p=.001). Postoperatively, women presented greater improvement 2 years from baseline for pain, function, and QoL (all p<.01). Women had better chances of a clinically important improvement than men for leg pain (odds ratio [OR]=1.39, 95% confidence interval [CI]: 1.19–1.61, p<.01) and back pain (OR=1.20,95% CI:1.03–1.40, p=.02) as well as ODI (OR=1.24, 95% CI:1.05–1.47, p=.01), but improved at a slower pace in leg pain (p<.001), back pain (p=.009), and disability (p=.008). No gender differences were found in QoL and return to work at 2 years postoperatively.

Conclusions

Swedish women do not have worse results than men after spinal fusion surgery. Female patients present with worse pain and function preoperatively, but improve more than men do after surgery.  相似文献   

15.

Background Context

Short-term readmission rates are becoming widely used as a quality and performance metric for hospitals. Data on unplanned short-term readmission after spine fusion for deformity in pediatric patients are limited.

Purpose

To characterize the rate and risk factors for short-term readmission after spine fusion for deformity in pediatric patients.

Study Design

This is a retrospective cohort study.

Patient Sample

Data were obtained from the State Inpatient Database from New York, Utah, Nebraska, Florida, North Carolina (years 2006–2010), and California (years 2006–2011).

Outcome Measures

Outcome measures included 30- and 90-day readmission rates.

Materials and Methods

Inclusion criteria were patients aged 0–21 years, a primary diagnosis of spine deformity, and a primary 3+-level lumbar or thoracic fusion. Exclusion criteria included revision surgery at index admission and cervical fusion. Readmission rates were calculated and logistic analyses were used to identify independent predictors of readmission.

Results

There were a total of 13,287 patients with a median age of 14 years. Sixty-seven percent were girls. The overall 30- and 90-day readmission rates were 4.7% and 6.1%. The most common reasons for readmission were infection (38% at 30 days and 33% at 90 days), wound dehiscence (19% and 17%), and pulmonary complications (12% and 13%). On multivariate analysis, predictors of 30-day readmission included male sex (p=.008), neuromuscular (p<.0001) or congenital scoliosis (p=.006), Scheuermann kyphosis (p=.003), Medicaid insurance (p<.0001), length of stay of ≤3 days or ≥6 days (p<.0001), and surgery at a teaching hospital (p=.011). Surgery at a hospital performing >80 operations/year was associated with a 34% reduced risk of 30-day readmission (95% confidence interval 12%-50%, p=.005) compared with hospitals performing <20 operations/year.

Conclusions

The short-term readmission rate for pediatric spine deformity surgery is driven by patient-related factors, as well as several risk factors that may be modified to reduce this rate.  相似文献   

16.

Background Context

The most commonly used materials used for interbody cages are titanium metal and polymer polyetheretherketone (PEEK). Both of these materials have demonstrated good biocompatibility. A major disadvantage associated with solid titanium cages is their radiopacity, limiting the postoperative monitoring of spinal fusion via standard imaging modalities. However, PEEK is radiolucent, allowing for a temporal assessment of the fusion mass by clinicians. On the other hand, PEEK is hydrophobic, which can limit bony ingrowth. Although both PEEK and titanium have demonstrated clinical success in obtaining a solid spinal fusion, innovations are being developed to improve fusion rates and to create stronger constructs using hybrid additive manufacturing approaches by incorporating both materials into a single interbody device.

Purpose

The purpose of this study was to examine the interbody fusion characteristic of a PEEK Titanium Composite (PTC) cage for use in lumbar fusion.

Study Design/Setting

Thirty-four mature female sheep underwent two-level (L2–L3 and L4–L5) interbody fusion using either a PEEK or a PTC cage (one of each per animal). Animals were sacrificed at 0, 8, 12, and 18 weeks post surgery.

Materials and Methods

Post sacrifice, each surgically treated functional spinal unit underwent non-destructive kinematic testing, microcomputed tomography scanning, and histomorphometric analyses.

Results

Relative to the standard PEEK cages, the PTC constructs demonstrated significant reductions in ranges of motion and a significant increase in stiffness. These biomechanical findings were reinforced by the presence of significantly more bone at the fusion site as well as ingrowth into the porous end plates.

Conclusions

Overall, the results indicate that PTC interbody devices could potentially lead to a more robust intervertebral fusion relative to a standard PEEK device in a clinical setting.  相似文献   

17.
18.

Background Context

The efficacy and safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) as a bone graft substitute in spinal fusion has been widely researched. However, no study of the efficacy and safety of Escherichia coli-derived rhBMP-2 (E.BMP-2) with a hydroxyapatite (HA) carrier has been proposed.

Purpose

This study aimed to compare the efficacy and safety of fusion materials between E.BMP-2 and autogenous iliac bone graft in posterolateral fusion (PLF).

Study Design/Setting

An open, active-controlled, randomized, multicenter trial was carried out.

Patient Sample

This study included 93 patients who underwent single-level lumbar or lumbosacral PLF.

Outcome Measures

The primary outcome measure was computed tomography (CT)-based fusion rate at 12 and 24 weeks. Secondary outcome measures were fusion grade by radiographs and CT at 12 and 24 weeks and changes in Oswestry Disability Index (ODI), Short Form-36 (SF-36) Health Survey, and visual analogue scale (VAS).

Methods

Patients who underwent 1-level PLF (between L1 and S1) for severe spinal stenosis or grade 1 spondylolisthesis were randomized to receive E.BMP-2 with an HA carrier (E.BMP-2 group) or autogenous iliac bone graft (AIBG group). Thin-section CT (<2?mm), VAS, ODI, and SF-36 were obtained pre- and postoperatively at 12 and 24 weeks. Outcome measures were compared between the groups.

Results

A total of 100 patients were enrolled in this trial. Among them, 93 patients underwent planned surgery. Preoperative demographic and clinical data showed no difference between groups. CT-based fusion rates were 100.0% (41/41) for the E.BMP-2 group and 90.2% (46/51) for the AIBG group (p=.062) at 12 weeks and 100.0% (41/41) and 94.1% (48/51) (p=.251) at 24 weeks, respectively. Fusion grade based on radiographs and CT showed non-inferiority of the E.BMP-2 group compared with the AIBG group. All clinical parameters improved postoperatively. However, there was no difference in changes in VAS, ODI, or SF-36 between the groups. No serious adverse event related to E.BMP-2 was found.

Conclusions

The fusion rate of E.BMP-2 was comparable with that of AIBG following PLF. Good clinical efficacy and safety of E.BMP-2 in spinal fusion were also revealed. It was also suggested that HA shows suitability as a carrier for E.BMP-2. Thus, E.BMP-2 with an HA carrier can be an alternative bone graft material in spinal fusion.  相似文献   

19.

Background Context

Spine pain and the disability associated with it are epidemic in the United States. According to the National Center for Health Statistics, more than 650,000 spinal fusion surgeries are performed annually in the United States, and yet there is a failure rate of 15%–40% when standard methods employing current commercial bone substitutes are used. Autologous bone graft is the gold standard in terms of fusion success, but the morbidity associated with the procedure and the limitations in the availability of sufficient material have limited its use in the majority of cases. A freely available and immunologically compatible bone mimetic with the properties of live tissue is likely to substantially improve the outcome of spine fusion procedures without the disadvantages of autologous bone graft.

Purpose

This study aimed to compare a live human bone tissue analog with autologous bone grafting in an immunocompromised rat model of posterolateral fusion.

Design/Setting

This is an in vitro and in vivo preclinical study of a novel human stem cell–derived construct for efficacy in posterolateral lumbar spine fusion.

Methods

Osteogenically enhanced human mesenchymal stem cells (OEhMSCs) were generated by exposure to conditions that activate the early stages of osteogenesis. Immunologic characteristics of OEhMSCs were evaluated in vitro. The secreted extracellular matrix from OEhMSCs was deposited on a clinical-grade gelatin sponge, resulting in bioconditioned gelatin sponge (BGS). Bioconditioned gelatin sponge was used alone, with live OEhMSCs (BGS+OEhMSCs), or with whole human bone marrow (BGS+hBM). Efficacy for spine fusion was determined by an institutionally approved animal model using 53 nude rats.

Results

Bioconditioned gelatin sponge with live OEhMSCs did not cause cytotoxicity when incubated with immunologically mismatched lymphocytes, and OEhMSCs inhibited lymphocyte expansion in mixed lymphocyte assays. Bioconditioned gelatin sponge with live OEhMSC and BGS+hBM constructs induced profound bone growth at fusion sites in vivo, with a comparable rate of fusion with syngeneic bone graft (negative [0 of 10], BGS alone [0 of 10], bone graft [7 of 10], BGS+OEhMSC [10 of 15], and BGS+hBM [8 of 8]).

Conclusions

Collectively, these studies demonstrate that BGS+OEhMSC constructs possess low immunogenicity and drive vertebral fusion with efficiency matching syngeneic bone graft in rodents. We also demonstrate that BGS serves as a promising scaffold for spine fusion when combined with hBM.  相似文献   

20.

Background Context

Activin A/BMP-2 chimera (AB204) could promote bone healing more effectively than recombinant bone morphogenetic protein 2 (rhBMP-2) with much lower dose in a rodent model, but there is no report about the effectiveness of AB204 in a large animal model.

Purpose

The purpose of this study was to compare the osteogenesis and fusion rate between AB204 and rhBMP-2 using biphasic calcium phosphate (BCP) as a carrier in a beagle's posterolateral lumbar fusion model.

Study Design

This is a randomized control animal study.

Methods

Seventeen male beagle dogs were included. Bilateral posterolateral fusion was performed at the L1–L2 and L4–L5 levels. Biphasic calcium phosphate (2?cc), rhBMP-2 (50?µg)+BCP (2?cc), or AB204 (50?µg)+BCP (2?cc) were implanted into the intertransverse space randomly. X-ray was performed at 4 and 8 weeks. After 8 weeks, the animals were sacrificed, and new bone formation and fusion rate were evaluated by manual palpation, computed tomography (CT), and undecalcified histology.

Results

The AB204 group showed significantly higher fusion rate (90%) than the rhBMP-2 group (15%) or the Osteon group (6.3%) by manual palpation. On x-ray and CT assessment, fusion rate and the volume of newly formed bone were also significantly higher in AB204 group than other groups. In contrast, more osteolysis was found in rhBMP-2 group (40%) than in AB204 group (10%) on CT study. In histologic results, new bone formation was sufficient between transverse processes in AB204 group, and obvious trabeculation and bone remodeling were observed. But in rhBMP-2 group, new bone formation was less than AB204 group and osteolysis was observed between the intertransverse spaces.

Conclusions

A low dose of AB204 with BCP as a carrier significantly promotes the fusion rate in a large animal model when compared with the rhBMP-2. These findings demonstrate that AB204 could be an alternative to rhBMP-2 to improve fusion rate.  相似文献   

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