Cervical fusion for treatment of degenerative conditions: development of appropriate use criteria.

BACKGROUND CONTEXT: High quality evidence is difficult to generate, leaving substantial knowledge gaps in the treatment of spinal conditions. Appropriate use criteria (AUC) are a means of determining appropriate recommendations when high quality evidence is lacking. PURPOSE: Define appropriate use criteria (AUC) of cervical fusion for treatment of degenerative conditions of the cervical spine. STUDY DESIGN/SETTING: Appropriate use criteria for cervical fusion were developed using the RAND/UCLA appropriateness methodology. Following development of clinical guidelines and scenario writing, a one-day workshop was held with a multidisciplinary group of 14 raters, all considered thought leaders in their respective fields, to determine final ratings for cervical fusion appropriateness for various clinical situations. OUTCOME MEASURES: Final rating for cervical fusion recommendation as either "Appropriate," "Uncertain" or "Rarely Appropriate" based on the median final rating among the raters. METHODS: Inclusion criteria for scenarios included patients aged 18 to 80 with degenerative conditions of the cervical spine. Key modifiers were defined and combined to develop a matrix of clinical scenarios. The median score among the raters was used to determine the final rating for each scenario. The final rating was compared between modifier levels. Spearman's rank correlation between each modifier and the final rating was determined. A multivariable ordinal regression model was fit to determine the adjusted odds of an "Appropriate" final rating while adjusting for radiographic diagnosis, number of levels and symptom type. Three decision trees were developed using decision tree classification models and variable importance for each tree was computed. RESULTS: Of the 263 scenarios, 47 (17.9 %) were rated as rarely appropriate, 66 (25%) as uncertain and 150 (57%) were rated as appropriate. Symptom type was the modifier most strongly correlated with the final rating (adjusted ρ2 = 0.58, p<.01). A multivariable ordinal regression adjusting for symptom type, diagnosis, and number of levels and showed high discriminative ability (C statistic = 0.90) and the adjusted odds ratio (aOR) of receiving a final rating of "Appropriate" was highest for myelopathy (aOR, 7.1) and radiculopathy (aOR, 4.8). Three decision tree models showed that symptom type and radiographic diagnosis had the highest variable importance. CONCLUSIONS: Appropriate use criteria for cervical fusion in the setting of cervical degenerative disorders were developed. Symptom type was most strongly correlated with final rating. Myelopathy or radiculopathy were most strongly associated with an "Appropriate" rating, while axial pain without stenosis was most associated with "Rarely Appropriate."

Guideline summary review: An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis.

BACKGROUND CONTEXT: The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis features evidence-based recommendations for diagnosing and treating degenerative lumbar spondylolisthesis. The guideline updates the 2008 guideline on this topic and is intended to reflect contemporary treatment concepts for symptomatic degenerative lumbar spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of May 2013. The NASS guideline on this topic is the only guideline on degenerative lumbar spondylolisthesis included in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse (NGC). PURPOSE: The purpose of this guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for patients with degenerative lumbar spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. STUDY DESIGN: A systematic review of clinical studies relevant to degenerative spondylolisthesis was carried out. METHODS: This NASS spondyolisthesis guideline is the product of the Degenerative Lumbar Spondylolisthesis Work Group of NASS' Evidence-Based Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members used the NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Degenerative Lumbar Spondylolisthesis guideline was accepted into the NGC and will be updated approximately every 5 years. RESULTS: Twenty-seven clinical questions were addressed in this guideline update, including 15 clinical questions from the original guideline and 12 new clinical questions. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. Twenty-one new or updated recommendations or consensus statements were issued and 13 recommendations or consensus statements were maintained from the original guideline. CONCLUSIONS: The clinical guideline was created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with degenerative lumbar spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flow chart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/Pages/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule.

An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy.

BACKGROUND CONTEXT: The objective of the North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy is to provide evidence-based recommendations to address key clinical questions surrounding the diagnosis and treatment of lumbar disc herniation with radiculopathy. The guideline is intended to reflect contemporary treatment concepts for symptomatic lumbar disc herniation with radiculopathy as reflected in the highest quality clinical literature available on this subject as of July 2011. The goals of the guideline recommendations are to assist in delivering optimum efficacious treatment and functional recovery from this spinal disorder. PURPOSE: To provide an evidence-based educational tool to assist spine specialists in the diagnosis and treatment of lumbar disc herniation with radiculopathy. STUDY DESIGN: Systematic review and evidence-based clinical guideline. METHODS: This guideline is a product of the Lumbar Disc Herniation with Radiculopathy Work Group of NASS' Evidence-Based Guideline Development Committee. The work group consisted of multidisciplinary spine care specialists trained in the principles of evidence-based analysis. A literature search addressing each question and using a specific search protocol was performed on English-language references found in Medline, Embase (Drugs and Pharmacology), and four additional evidence-based databases to identify articles. The relevant literature was then independently rated using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final recommendations to answer each clinical question were developed via work group discussion, and grades were assigned to the recommendations using standardized grades of recommendation. In the absence of Level I to IV evidence, work group consensus statements have been developed using a modified nominal group technique, and these statements are clearly identified as such in the guideline. RESULTS: Twenty-nine clinical questions were formulated and addressed, and the answers are summarized in this article. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. CONCLUSIONS: The clinical guideline has been created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with symptomatic lumbar disc herniation with radiculopathy. The entire guideline document, including the evidentiary tables, suggestions for future research, and all the references, is available electronically on the NASS Web site at http://www.spine.org/Pages/PracticePolicy/ClinicalCare/ClinicalGuidlines/Default.aspx and will remain updated on a timely schedule.

Meta-analysis of vertebral augmentation compared with conservative treatment for osteoporotic spinal fractures.

Cement augmentation is a controversial treatment for painful vertebral compression fractures (VCF). Our research questions for the meta-analysis were: Is there a clinical and statistical difference in pain relief, functional improvement, and quality of life between conservative care and cement augmentation for VCF and, if so, are they maintained at longer time points? We conducted a search of MEDLINE from January 1980 to July 2011 using PubMed, Cochrane Database of Systematic Reviews and Controlled Trials, CINAHL, and EMBASE. Searches were performed from medical subject headings. Terms "vertebroplasty" and "compression fracture" were used. The outcome variables of pain, functional measures, health-related quality of life (HRQOL), and new fracture risk were analyzed. A random effects model was chosen. Continuous variables were calculated using the standardized mean difference comparing improvement from baseline of the experimental group with the control group. New vertebral fracture risk was calculated using log odds ratio. Six studies met the criteria. The pain visual analog scale (VAS) mean difference was 0.73 (confidence interval [CI] 0.35, 1.10) for early (<12 weeks) and 0.58 (CI 0.19, 0.97) for late time points (6 to 12 months), favoring vertebroplasty (p < 0.001). The functional outcomes at early and late time points were statistically significant with 1.08 (CI 0.33, 1.82) and 1.16 (CI 0.14, 2.18), respectively. The HRQOL showed superior results of vertebroplasty compared with conservative care at early and late time points of 0.39 (CI 0.16, 0.62) and 0.33 (CI 0.16, 0.51), respectively. Secondary fractures were not statistically different between the groups, 0.065 (CI -0.57, 0.70). This meta-analysis showed greater pain relief, functional recovery, and health-related quality of life with cement augmentation compared with controls. Cement augmentation results were significant in the early (<12 weeks) and the late time points (6 to 12 months). This meta-analysis provides strong evidence in favor of cement augmentation in the treatment of symptomatic VCF fractures.

Clearance of the asymptomatic cervical spine: a meta-analysis.

OBJECTIVES: To perform a comprehensive review of the literature and subsequent meta-analysis of data regarding appropriate clearance of the asymptomatic cervical spine in blunt trauma patients. The goal is to identify an asymptomatic patient group that can safely be cleared of cervical spine immobilization without radiographic evaluation. DATA SOURCES: The National Library of Medicine was searched for English-language articles published between 1966 and December 2004. The key words spinal injury, spinal fracture, spinal injuries, cervical, clearance, diagnosis, and radiography were used to perform the search. STUDY SELECTION: Inclusion criteria were 1) a prospectively applied protocol; 2) reported outcomes to allow calculation of sensitivity, specificity, negative predictive value, and positive predictive value; and 3) follow up to determine the status of potential injuries with minimum of a 2-week telephone call or a computerized tomography scan. No exclusion criteria were applied. DATA EXTRACTION: The three senior authors independently confirmed the validity of the included papers for meeting appropriate criteria for the meta-analysis. True-positives, true-negatives, false-positives, and false-negatives were extracted from these studies. DATA SYNTHESIS: Original scale and log odds meta-analysis were performed using random effects methodology to calculate sensitivity, specificity, positive predictive value, and negative predictive value. CONCLUSIONS: An alert, asymptomatic patient without a distracting injury or neurologic deficit who is able to complete a functional range-of-motion examination may safely be cleared from cervical spine immobilization without radiographic evaluation (sensitivity = 98.1%, negative predictive value = 99.8%).

Analysis of cartilage tissue on a cellular level in fresh osteochondral allograft retrievals.

BACKGROUND: Fresh human osteochondral allografting is a biological cartilage replacement technique used to treat articular and osteoarticular defects in the knee. A small number of grafts fail, and we analyzed every retrieved graft during a 4-year period in order to learn more about the potential causes of failure. HYPOTHESIS: A large percentage of chondrocytes still remain viable many years after fresh osteochondral allografting. STUDY DESIGN: Descriptive laboratory study. METHODS: Retrieval specimens were obtained at the time of revision surgery and immediately analyzed. Chondrocyte viability and viable cell density were determined using a live/dead staining technique followed by confocal microscopy. Glycosaminoglycan content was a measure of the cartilage matrix. Radiolabeled sulfate uptake served as a biochemical marker of chondrocyte metabolic activity. Cartilage and subchondral bone were examined histologically. RESULTS: Fourteen patients yielded a total of 26 retrieval specimens that had been originally implanted as individual fresh osteochondral allografts. Average graft survival was 42 months. Chondrocyte viability was 82% +/- 17%, and chondrocyte viable cell density was 15 590 +/- 5900 viable cells/mm(3). Retrieved tissue demonstrated radiolabeled sulfate uptake of 437 +/- 270 counts per minute and 3.5% +/- 0.8% hexosamine per dry weight. Histologically, all specimens showed some degree of cartilage fibrillation. There was evidence of bone allograft incorporation in most specimens, as well as pannus formation in 4 specimens, but no evidence of immune rejection. CONCLUSION: A small percentage of fresh osteochondral allografts fail, but the precise cause is unknown. The main theories for failure investigated here include immunologic rejection, failure of bony incorporation, and chondrocyte death causing breakdown of the cartilage matrix. We show that chondrocytes remain viable many years after transplantation, allograft bone incorporates, and immune rejection does not seem to play a primary role in failure. CLINICAL RELEVANCE: Fresh osteochondral allografting is becoming more common in the treatment of articular cartilage defects in the knee. Our findings support the paradigm of fresh osteochondral allografting, the transplantation of hyaline cartilage with biological incorporation of the underlying bone scaffold. The reasons for failure of a small percentage of grafts remain unclear.

Pisotriquetral arthrodesis as an alternative to excision for pisotriquetral instability in high-demand patients: a case report in a gymnast.

UNLABELLED: A gymanast developed ulnar wrist pain caused by pisotriquetral instability. Pisotriquetral arthrodesis resulted in pain relief and sufficient functional return to allow her to return to gymnastics. Pisotriquetral arthrodesis is a feasible alternative to pisiform excision worth consideration in high-demand patients with symptomatic pisotriquetral instability or arthrosis. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic, Level V.

Preincubation of tissue engineered constructs enhances donor cell retention.

Cartilage tissue engineering has been the focus of considerable research. However, the fate of transplanted donor cells rarely is explored directly. In the current study, the effect of preincubating perichondrial cells into a polylactic acid scaffold before implantation into an osteochondral defect was studied. The extracellular matrix produced during preincubation was characterized; the viability of the donor cells was assessed; and the retention of the donor cells in the repair tissue was determined using a gene marker on the Y chromosome, the gender-determining region Y gene. During in vitro incubation, the cells produced an extracellular matrix consisting of glycosaminoglycans, and Types I and II collagen, and the cell viability remained great. In vivo, preincubated constructs had significantly greater retention of donor cells in the host repair tissue in the short term when compared with nonincubated controls. This study shows the value of preincubating engineered constructs before implantation, and additionally validates the gender-determining region Y gene as an effective tool for assessing the fate of donor cells in cartilage tissue engineering.

The effects of storage on fresh human osteochondral allografts.

Historically, fresh human osteochondral allografts have been stored in lactated Ringer's solution at 4 degrees C and then transplanted as quickly as possible, generally within 2 to 5 days, to ensure delivery of a high level of viable chondrocytes. Recently, allograft distribution companies have begun to provide fresh osteochondral allografts that are stored in a proprietary culture medium usually for at least 2 weeks before delivery to the surgeon for implantation. The effects of such storage on human cartilage have not been well-defined. In the current study the effects of storage in lactated Ringer's solution and in culture media were assessed. After 7 days of storage in lactated Ringer's solution, a significant decline in chondrocyte viability and metabolic activity was seen. Culture media provided significantly better preservation of the cartilage with viability and metabolic activity remaining essentially unchanged from baseline for as many as 14 days. The biochemical and biomechanical properties of the extracellular matrix remained stable with storage in both solutions with time. These data suggest that osteochondral allografts stored under traditional conditions in lactated Ringer's solution should continue to be implanted as quickly as possible and certainly within 7 days of donor death. If kept in culture media, the storage duration may be extended to approximately 2 weeks.

Use of allografts in the management of ankle arthritis.

Reconstruction of articular cartilage defects of the tibiotalar joint remains a challenge. Although arthrodesis and total ankle arthroplasty are treatment options, we present fresh tibiotalar allografting as an alternative technique. The average age of 12 patients who underwent tibiotalar allografting was 43 years. The average follow-up was 21 months. All grafts healed at the host/donor interface. Complications included intraoperative fracture in one patient and graft collapse that required revision allografting in another. Most patients were relieved of preoperative pain and were satisfied with the procedure. Postoperative function was also significantly improved, based on questionnaire and physician assessment. Fresh tibiotalar allografting is an exciting and promising technique in the treatment of articular cartilage defects in young, active patients.

Treatment of post-traumatic ankle arthrosis with bipolar tibiotalar osteochondral shell allografts.

We report on tibiotalar osteochondral shell allografts for post-traumatic ankle arthropathy in seven patients. Average follow-up was 148 months (range, 85 to 198). Patients were evaluated by a questionnaire, SF-12 survey, ankle score, physical exam and radiographs. The ankle score increased from 25 preoperatively to 43 at latest follow-up (maximum score 100). SF-12 scores increased from 30 to 38 (Physical Component) and 46 to 53 (Mental Component). The failure rate was 42%. Four of seven patients reported good or excellent results. Five patients stated they would undergo a similar procedure again. Complications included graft fragmentation, poor graft fit, graft subluxation, and non-union. Follow-up radiographs demonstrated joint space narrowing, osteophytes, and sclerosis, even in cases with excellent clinical status. Fresh osteochondral shell allografting may provide a viable alternative for the treatment of post-traumatic ankle arthrosis in selected individuals.