Utilization of Bone-Anchored Annular Defect Closure to Prevent Reherniation Following Lumbar Discectomy: Overcoming Barriers to Clinical Adoption and Market Access.

While achieving premarket approval from the US Food and Drug Administration represents a significant milestone in the development and commercialization of a Class III medical device, the aftermath endeavor of gaining market access can be daunting. This article provides a case study of the Barricaid annular closure device (Barricaid), a reherniation reduction device, which has been demonstrated to decrease the risk of suffering a recurrent lumbar intervertebral disc herniation. Following Food and Drug Administration approval, clinical adoption has been slow due to barriers to market access, including the perception of low-quality clinical evidence, questionable significance of the medical necessity of the procedure, and imaging evidence of increased likelihood of vertebral endplate changes. The aim of this article is to provide appropriate examination, rationale, and rebuttal of these concerns. Weighing the compendium of evidence, we offer a definition of a separate and unique current procedural terminology code to delineate this procedure. Adoption of this code will help to streamline the processing of claims and support the conduct of research, the evaluation of health care utilization, and the development of appropriate medical guidelines.

The treatment of symptomatic osteoporotic spinal compression fractures.

This clinical practice guideline is based on a series of systematic reviews of published studies on the treatment of symptomatic osteoporotic spinal compression fractures. Of 11 recommendations, one is strong; one, moderate; three, weak; and six, inconclusive. The strong recommendation is against the use of vertebroplasty to treat the fractures; the moderate recommendation is for the use of calcitonin for 4 weeks following the onset of fracture. The weak recommendations address the use of ibandronate and strontium ranelate to prevent additional symptomatic fractures, the use of L2 nerve root blocks to treat the pain associated with L3 or L4 fractures, and the use of kyphoplasty to treat symptomatic fractures in patients who are neurologically intact.

Optimizing the management of rotator cuff problems.

Of the 31 recommendations made by the work group, 19 were determined to be inconclusive because of the absence of definitive evidence. Of the remaining recommendations, four were classified as moderate grade, six as weak, and two as consensus statements of expert opinion. The four moderate-grade recommendations include suggestions that exercise and nonsteroidal anti-inflammatory drugs be used to manage rotator cuff symptoms in the absence of a full-thickness tear, that routine acromioplasty is not required at the time of rotator cuff repair, that non-cross-linked, porcine small intestine submucosal xenograft patches not be used to manage rotator cuff tears, and that surgeons can advise patients that workers' compensation status correlates with less favorable outcomes after rotator cuff surgery.

Diagnosis and treatment of osteochondritis dissecans.

This clinical practice guideline is based on a series of systematic reviews of published studies in the available literature on the diagnosis and treatment of osteochondritis dissecans of the knee. None of the 16 recommendations made by the work group is graded as strong; most are graded inconclusive; two are graded weak; and four are consensus statements. Both of the weak recommendations are related to imaging evaluation. For patients with knee symptoms, radiographs of the joint may be obtained to identify the lesion. For patients with radiographically apparent lesions, MRI may be used to further characterize the osteochondritis dissecans lesion or identify other knee pathology.

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."

Diagnosis of periprosthetic joint infections of the hip and knee.

No preferred test for diagnosis of periprosthetic joint infection exists, and the algorithm for the workup of patients suspected of infection remains unclear. The work group evaluated the available literature to determine the role of each diagnostic modality and devise a practical algorithm that allows physicians to reach diagnosis of periprosthetic joint infection. Ten of the 15 recommendations have strong or moderate evidence in support. These include matters involving erythrocyte sedimentation rate and C-reactive protein level testing, knee and hip aspiration, and stopping the use of antibiotics prior to obtaining intra-articular cultures. The group recommends against the use of intraoperative Gram stain but does recommend the use of frozen sections of peri-implant tissues in reoperation patients in whom infection has not been established, as well as multiple cultures in reoperation patients being assessed for infection. The group recommends against initiating antibiotic treatment in patients with suspected infection until after joint cultures have been obtained, but recommends that prophylactic preoperative antibiotics not be withheld in patients at lower probability for infection.

Bone void fillers.

For this technology overview, the tools of evidence-based medicine were used to summarize information on the effectiveness and clinical outcomes related to the usage of bone void fillers- specifically, synthetic graft materials. Comprehensive literature searches were conducted to address five key questions, which the task force that prepared the report posed as follows. Question 1 addressed the use of synthetic bone void fillers alone. Question 2 was designed to determine whether synthetic bone void fillers could successfully serve as graft extenders and eliminate the need for iliac crest bone graft. Questions 3, 4, and 5 addressed the use of allografts as a comparison with synthetic fillers because clinical results with allografts are perceived as being much closer to autografts in these areas of the spine.

Modern metal-on-metal hip resurfacing.

For this technology overview, the tools of evidence-based medicine were used to summarize information on the indications, effectiveness, and failure rates of modern metal-on-metal hip resurfacing technology. The task was complicated by the fact that resurfacing arthroplasty is commonly offered only to a subset of patients who are candidates for total hip replacement, often prohibiting direct comparisons. Comprehensive literature searches were conducted to address four key questions addressing revision rates, patient characteristics, effectiveness of treatment, and whether improved technique, surgeon experience, and/or patient selection lead to improved outcomes. Despite data limitations, it is apparent that revision rates are higher after resurfacing than after total hip arthroplasty. Potential prognostic indicators did not yield a consistent predictor of patient-oriented outcomes (eg, pain relief) for either resurfacing arthroplasty or total hip replacement. Because of differences between patients who received hip resurfacing and those who received total hip arthroplasty, the results of studies comparing these techniques cannot be interpreted. Finally, changes in technique and increased experience result in a decrease in revision rates and femoral neck fractures and improved pain and hip scores in resurfacing.

Cervical disc arthroplasty.

This technology overview addressed four questions that compared the difference in outcomes between patients undergoing cervical disc arthroplasty with patients undergoing anterior cervical diskectomy fusion. Most studies did not either report or conduct the appropriate statistical analyses to examine predictive characteristics in patients with successful clinical outcomes. Most studies were inconclusive or unreliable regarding clinical outcomes and revision and/or complication rates in patients who present with neck and/or arm pain. No significant difference in the length of hospital stay was reported; however, two studies included in the overview reported that patients treated with cervical disc arthroplasty returned to work in significantly fewer days (range, 14 to 16 days) than did patients treated with anterior cervical diskectomy fusion.

Diagnosis and treatment of acute Achilles tendon rupture.

This clinical practice guideline is based on a series of systematic reviews of published studies in the available literature on the diagnosis and treatment of acute Achilles tendon rupture. None of the 16 recommendations made by the work group was graded as strong; most are graded inconclusive; four are graded weak; two are graded as moderate strength; and two are consensus statements. The two moderate-strength recommendations include the suggestions for early postoperative protective weight bearing and for the use of protective devices that allow for postoperative mobilization.

Treatment of glenohumeral osteoarthritis.

This clinical practice guideline is based on a systematic review of published studies on the treatment of glenohumeral osteoarthritis in the adult patient population. Of the 16 recommendations addressed, nine are inconclusive. Two were reached by consensus-that physicians use perioperative mechanical and/or chemical venous thromboembolism prophylaxis for shoulder arthroplasty patients and that total shoulder arthroplasty not be performed in patients with glenohumeral osteoarthritis who have an irreparable rotator cuff tear. Four options were graded as weak: the use of injectable viscosupplementation; total shoulder arthroplasty and hemiarthroplasty as treatment; avoiding shoulder arthroplasty by surgeons who perform fewer than two shoulder arthroplasties per year (to reduce the risk of immediate postoperative complications); and the use of keeled or pegged all-polyethylene cemented glenoid components. The single moderate-rated recommendation was for the use of total shoulder arthroplasty rather than hemiarthroplasty. Management of glenohumeral osteoarthritis remains controversial; the scientific evidence on this topic can be significantly improved.

Treatment of distal radius fractures.

The clinical practice guideline is based on a systematic review of published studies on the treatment of distal radius fractures in adults. None of the 29 recommendations made by the work group was graded as strong; most are graded as inconclusive or consensus; seven are graded as weak. The remaining five moderate-strength recommendations include surgical fixation, rather than cast fixation, for fractures with postreduction radial shortening >3 mm, dorsal tilt >10 degrees , or intra-articular displacement or step-off >2 mm; use of rigid immobilization rather than removable splints for nonsurgical treatment; making a postreduction true lateral radiograph of the carpus to assess dorsal radial ulnar joint alignment; beginning early wrist motion following stable fixation; and recommending adjuvant treatment with vitamin C to prevent disproportionate pain.

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain.

BACKGROUND CONTEXT: The North American Spine Society's (NASS) Evidence Based Clinical Guideline for the Diagnosis and Treatment of Low Back Pain features evidence-based recommendations for diagnosing and treating adult patients with nonspecific low back pain. The guideline is intended to reflect contemporary treatment concepts for nonspecific low back pain as reflected in the highest quality clinical literature available on this subject as of February 2016. PURPOSE: The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with nonspecific low back pain. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. STUDY DESIGN: This is a guideline summary review. METHODS: This guideline is the product of the Low Back Pain Work Group of NASS' Evidence-Based Clinical 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 utilized 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 guideline was submitted to an internal and external peer review process and ultimately approved by the NASS Board of Directors. RESULTS: Eighty-two clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. CONCLUSIONS: The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with nonspecific low back pain. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx.

Prevention of symptomatic pulmonary embolism in patients undergoing total hip or knee arthroplasty.

This clinical practice guideline is based on a systematic review of published studies on the management of adult patients undergoing total hip replacement (THR) or total knee replacement (TKR) aimed specifically at preventing symptomatic pulmonary embolism (PE). The guideline emphasizes the need to assess the patient's risk for both PE and postoperative bleeding. Mechanical prophylaxis and early mobilization are recommended for all patients. Chemoprophylactic agents were evaluated using a systematic literature review. Forty-two studies met eligibility criteria, of which 23 included patients who had TKR and 25 included patients who had THR. The following statements summarize the recommendations for chemoprophylaxis: Patients at standard risk of both PE and major bleeding should be considered for aspirin, low-molecular-weight heparin (LMWH), synthetic pentasaccharides, or warfarin with an international normalized ratio (INR) goal of < or =2.0. Patients at elevated (above standard) risk of PE and at standard risk of major bleeding should be considered for LMWH, synthetic pentasaccharides, or warfarin with an INR goal of < or =2.0. Patients at standard risk of PE and at elevated (above standard) risk of major bleeding should be considered for aspirin, warfarin with an INR goal of < or =2.0, or none. Patients at elevated (above standard) risk of both PE and major bleeding should be considered for aspirin, warfarin with an INR goal of < or =2.0, or none.

Locking plates for extremity fractures.

Thirty-three peer-reviewed studies met the inclusion criteria for the Overview. Criteria were framed by three key questions regarding indications for the use of locking plates, their effectiveness in comparison with traditional nonlocking plates, and their cost-effectiveness. The studies were divided into seven applications: distal radius, proximal humerus, distal femur, periprosthetic femur, tibial plateau (AO/OTA type C), proximal tibia (AO/OTA type A or C), and distal tibia. Patient enrollment criteria were recorded to determine indications for use of locking plates, but the published studies do not consistently report the same enrollment criteria. Regarding effectiveness, there were no statistically significant differences between locking plates and nonlocking plates for patient-oriented outcomes, adverse events, or complications. The literature search did not identify any peer-reviewed studies that address the cost-effectiveness or cost-utility of locking plates.

Treatment of carpal tunnel syndrome.

In September 2008, the Board of Directors of the American Academy of Orthopaedic Surgeons approved a clinical practice guideline on the treatment of carpal tunnel syndrome. This guideline was subsequently endorsed by the American Association of Neurological Surgeons and the Congress of Neurological Surgeons. The guideline makes nine specific recommendations: A course of nonsurgical treatment is an option in patients diagnosed with carpal tunnel syndrome. Early surgery is an option with clinical evidence of median nerve denervation or when the patient so elects. Another nonsurgical treatment or surgery is suggested when the current treatment fails to resolve symptoms within 2 to 7 weeks. Sufficient evidence is not available to provide specific treatment recommendations for carpal tunnel syndrome associated with such conditions as diabetes mellitus and coexistent cervical radiculopathy. Local steroid injection or splinting is suggested before considering surgery. Oral steroids or ultrasound are options. Carpal tunnel release is recommended as treatment. Heat therapy is not among the options to be used. Surgical treatment of carpal tunnel syndrome by complete division of the flexor retinaculum is recommended. Routine use of skin nerve preservation and epineurotomy is not suggested when carpal tunnel release is performed. Prescribing preoperative antibiotics for carpal tunnel surgery is an option. It is suggested that the wrist not be immobilized postoperatively after routine carpal tunnel surgery. It is suggested that instruments such as the Boston Carpal Tunnel Questionnaire and the Disabilities of the Arm, Shoulder, and Hand questionnaire be used to assess patient responses to carpal tunnel syndrome treatment for research.

Diagnosis of carpal tunnel syndrome.

This clinical practice guideline was created to improve patient care by outlining the appropriate information-gathering and decision-making processes involved in managing the diagnosis of carpal tunnel syndrome. The methods used to develop this clinical practice guideline were designed to combat bias, enhance transparency, and promote reproducibility. The guideline's recommendations are as follows: The physician should obtain an accurate patient history. The physician should perform a physical examination of the patient that may include personal characteristics as well as performing a sensory examination, manual muscle testing of the upper extremity, and provocative and/or discriminatory tests for alternative diagnoses. The physician may obtain electrodiagnostic tests to differentiate among diagnoses. This may be done in the presence of thenar atrophy and/or persistent numbness. The physician should obtain electrodiagnostic tests when clinical and/or provocative tests are positive and surgical management is being considered. If the physician orders electrodiagnostic tests, the testing protocol should follow the American Academy of Neurology/American Association of Neuromuscular and Electrodiagnostic Medicine/American Academy of Physical Medicine and Rehabilitation guidelines for diagnosis of carpal tunnel syndrome. In addition, the physician should not routinely evaluate patients suspected of having carpal tunnel syndrome with new technology, such as magnetic resonance imaging, computed tomography, and pressure-specified sensorimotor devices in the wrist and hand. This decision was based on an additional nonsystematic literature review following the face-to-face meeting of the work group.

Treatment of osteoarthritis of the knee (nonarthroplasty).

The clinical practice guideline was explicitly developed to include only treatments less invasive than knee replacement (ie, arthroplasty). Patients with symptomatic osteoarthritis of the knee are to be encouraged to participate in self-management educational programs and to engage in self-care, as well as to lose weight and engage in exercise and quadriceps strengthening. The guideline recommends taping for short-term relief of pain as well as analgesics and intra-articular corticosteroids, but not glucosamine and/or chondroitin. Patients need not undergo needle lavage or arthroscopy with débridement or lavage. Patients may consider partial meniscectomy or loose body removal or realignment osteotomy, as conditions warrant. Use of a free-floating interpositional device should not be considered for symptomatic unicompartmental osteoarthritis of the knee. Lateral heel wedges should not be prescribed for patients with symptomatic medial compartmental osteoarthritis of the knee. The work group was unable either to recommend or not recommend the use of braces with either valgus- or varus-directing forces for patients with medial unicompartmental osteoarthritis; the use of acupuncture or of hyaluronic acid; or osteotomy of the tibial tubercle for isolated symptomatic patellofemoral osteoarthritis.

Treatment of pediatric diaphyseal femur fractures.

Methods of treating pediatric diaphyseal femur fractures are dictated by patient age, fracture characteristics, and family social situation. The recent trend has been away from nonsurgical treatment and toward surgical stabilization. The clinical practice guideline on pediatric diaphyseal femur fractures was undertaken to determine the best evidence regarding a number of different options for surgical stabilization. The recommendations address treatments that include Pavlik harness, spica casts, flexible intramedullary nailing, rigid trochanteric entry nailing, submuscular plating, and pain management. The guideline authors conclude that controversy and lack of conclusive evidence remain regarding the different treatment options for pediatric femur fractures and that the quality of scientific evidence could be improved for the revised guideline.