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https://www.readbyqxmd.com/read/28738891/pivotal-trials-of-orthopedic-surgical-devices-in-the-united-states-predominance-of-two-arm-non-inferiority-designs
#1
S Raymond Golish
BACKGROUND: The United States Food and Drug Administration (FDA) reviews class III orthopedic devices submitted for premarket approval with pivotal clinical trials. The purpose of this study was to determine the types of orthopedic devices reviewed, the design of their pivotal clinical trials, and the subjective factors affecting the interpretation of clinical trial data. METHODS: Meetings of the FDA Orthopaedic and Rehabilitation Devices Panel were identified from 2000-2016...
July 24, 2017: Trials
https://www.readbyqxmd.com/read/28658157/efficacy-of-tranexamic-acid-plus-drain-clamping-to-reduce-blood-loss-in-total-knee-arthroplasty-a-meta-analysis
#2
REVIEW
Yan Zhang, Jun-Wei Zhang, Bao-Hua Wang
BACKGROUND: Perioperative blood loss is still an unsolved problem in total knee arthroplasty (TKA). The efficacy of the preoperative use of tranexamic acid (TXA) plus drain-clamping to reduce blood loss in TKA has been debated. This meta-analysis aimed to illustrate the efficacy of TXA plus drain-clamping to reduce blood loss in patients who underwent a TKA. METHODS: In February 2017, a systematic computer-based search was conducted in PubMed, EMBASE, Web of Science, the Cochrane Database of Systematic Reviews, and Google Scholar...
June 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28653546/cruciate-retaining-compared-with-posterior-stabilised-nexgen-total-knee-arthroplasty-results-at-10-years-in-a-matched-cohort
#3
Aiw Mayne, H P Harshavardhan, L R Johnston, W Wang, A Jariwala
INTRODUCTION Debate has persisted for many years about whether to sacrifice or replace the posterior cruciate ligament when performing total knee arthroplasty. A paucity of long-term follow-up studies comparing outcomes between cruciate-retaining and posterior-stabilised knees exist. We aimed to compare results at ten-year follow-up. METHODS A matched paired study comparing a cohort of 107 Zimmer Nexgen® Cruciate Retaining (CR) patients with a cohort of 107 Nexgen Posterior-Stabilised (PS) knees matched for age, sex, body mass index and preoperative American Knee Society score was undertaken...
June 27, 2017: Annals of the Royal College of Surgeons of England
https://www.readbyqxmd.com/read/28640101/liposomal-bupivacaine-versus-traditional-bupivacaine-for-pain-control-after-total-hip-arthroplasty-a-meta-analysis
#4
REVIEW
Ting-Ting Ma, Yu-Hui Wang, Yun-Feng Jiang, Cong-Bin Peng, Chao Yan, Zi-Gui Liu, Wei-Xing Xu
BACKGROUND: In the past, the efficacy of local infiltration of liposomal bupivacaine for total hip arthroplasty (THA) patients was in debate. Therefore, this meta-analysis was conducted to determine whether local infiltration of liposomal bupivacaine provides better pain relief after THA. METHODS: We searched Web of Science, PubMed, Embase, and the Cochrane Library databases to the April 2017. Any studies comparing liposomal bupivacaine and traditional bupivacaine were included in our meta-analysis...
June 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28567339/hallux-rigidus-how-do-i-approach-it
#5
REVIEW
Aaron Lam, Jimmy J Chan, Michele F Surace, Ettore Vulcano
Hallux rigidus is a degenerative disease of the first metatarsalphalangeal (MTP) joint and affects 2.5% of people over age 50. Dorsal osteophytes and narrowed joint space leads to debilitating pain and limited range of motion. Altered gait mechanics often ensued as 119% of the body force transmit through the 1(st) MTP joint during gait cycle. Precise etiology remains under debate with trauma being often cited in the literature. Hallux valgus interphalangeus, female gender, inflammatory and metabolic conditions have all been identified as associative factors...
May 18, 2017: World Journal of Orthopedics
https://www.readbyqxmd.com/read/28526923/focal-articular-prosthetic-resurfacing-for-the-treatment-of-full-thickness-articular-cartilage-defects-in-the-knee-12-year-follow-up-of-two-cases-and-review-of-the-literature
#6
C Becher, E B Cantiller
INTRODUCTION: The rationale of focal articular prosthetic resurfacing used as a primary arthroplasty procedure in the treatment of articular cartilage defects is still under debate. Conflicting reports raise concern about high rates of re-operations and continued development of osteoarthritis, while others have reported good outcomes. The goal of this paper is to present the long-term results of two patients with a 12-year follow-up and to report the results of a literature review. MATERIALS AND METHODS: Two patients (male, 70 years; female 63 years) with a follow-up of 12 years were reviewed...
May 19, 2017: Archives of Orthopaedic and Trauma Surgery
https://www.readbyqxmd.com/read/28525999/is-soft-tissue-repair-a-right-choice-to-avoid-early-dislocation-after-tha-in-posterior-approach
#7
Yiqin Zhou, Shiqi Cao, Lintao Li, Manoj Narava, Qiwei Fu, Qirong Qian
BACKGROUND: Dislocation is the second most common complication after total hip arthroplasty (THA). The effectiveness of soft tissue repair to reduce dislocation rate is still debated and thus a meta-analysis was conducted. METHODS: A systematic search in PubMed, Embase, and Cochrane databases was conducted for this meta-analysis. INCLUSION CRITERIA: clinical comparative trials on the use of soft tissue repair including rotators and capsule repair in primary THA...
May 19, 2017: BMC Surgery
https://www.readbyqxmd.com/read/28390888/liposomal-bupivacaine-mixture-has-similar-pain-relief-and-significantly-fewer-complications-at-less-cost-compared-to-indwelling-interscalene-catheter-in-total-shoulder-arthroplasty
#8
William J Weller, Michael G Azzam, Richard A Smith, Frederick M Azar, Thomas W Throckmorton
BACKGROUND: The efficacy and costs of indwelling interscalene catheter (ISC) and liposomal bupivacaine (LBC), with and without adjunctive medications, in patients with primary shoulder arthroplasty are a source of current debate. METHODS: In 214 arthroplasties, 156 patients had ISC and 58 had LBC injections that were mixed with morphine, ketorolac, and 0.5% bupivacaine with epinephrine. Charts were reviewed for visual analog scale pain scores, oral morphine equivalent (OME) usage, major complications, and costs...
March 16, 2017: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28390887/single-stage-revision-arthroplasty-for-infection-an-underutilized-treatment-strategy
#9
Jonathan J Negus, Peter B Gifford, Fares S Haddad
BACKGROUND: The burden of revision arthroplasty surgery for infection is rising as the rate of primary arthroplasty surgery increases. Infected arthroplasty rates are now relatively low, but the sheer increase in volume is leading to considerable patient morbidity and significant increases in costs to the health care system. Single-stage revision for infection is one of the several accepted treatment options, but the indications and results are debated. This review aims to clarify the current evidence...
March 2, 2017: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28378009/the-utility-of-bicruciate-retaining-total-knee-arthroplasty
#10
Feroz A Osmani, Savyasachi C Thakkar, Kristopher Collins, Ran Schwarzkopf
BACKGROUND: We describe the features of modern and historical bicruciate-retaining (BCR) total knee arthroplasty (TKA) implants compared with other TKA implant designs, reviewing kinematics, proprioception, operative technique, and clinical results. METHODS: We performed a review based on PubMed, Embase, CINAHL Plus, and Cochrane databases from January 1990 to April 2016 using combinations of the following keywords: "bicruciate-retaining arthroplasty," "bicruciate-retaining total knee arthroplasty," "bicruciate-retaining TKA," "kinematics," "knee kinematics," and "TKA kinematics...
March 2017: Arthroplasty Today
https://www.readbyqxmd.com/read/28373980/clinical-results-and-serum-metal-ion-concentrations-following-ceramic-on-metal-total-hip-arthroplasty-at-a-mean-follow-up-of-60-months
#11
W Maurer-Ertl, D Pranckh-Matzke, J Friesenbichler, G Bratschitsch, L A Holzer, M Maier, A Leithner
Background. Increased metal ion levels following total hip arthroplasty (THA) with metal-on-metal bearings are a highly debated topic. Local soft tissue reactions with chronic pain and systemic side effects such as neuropathy are described. The aim of the current study was to determine the serum metal ion concentrations of Cobalt (Co) and Chrome (Cr) after THA with a ceramic-on-metal (CoM) bearing. Patients and Methods. Between 2008 and 2010, 20 patients underwent THA using a CoM bearing. Clinical function was evaluated by standardized scores systems (Harris Hip Score and WOMAC Score) and radiological examination included X-rays...
2017: BioMed Research International
https://www.readbyqxmd.com/read/28367694/long-term-follow-up-of-arthrodesis-vs-total-joint-arthroplasty-for-hallux-rigidus
#12
Oliver D Stone, Robbie Ray, Colin E Thomson, J N Alastair Gibson
BACKGROUND: The optimal operative management of hallux rigidus is still a matter for debate among surgeons. Despite arthrodesis widely considered to be the gold standard treatment, many surgeons advocate arthroplasty as a suitable alternative. There are, however, few long-term or high-quality studies evaluating these modalities. We present the 15-year follow-up of a randomized controlled trial. METHODS: This data is the follow-up to the original study published in 2005...
April 2017: Foot & Ankle International
https://www.readbyqxmd.com/read/28351371/unicompartmental-knee-arthroplasty-is-it-superior-to-high-tibial-osteotomy-in-treating-unicompartmental-osteoarthritis-a-meta-analysis-and-systemic-review
#13
REVIEW
Marcel Budhi Santoso, Lidong Wu
BACKGROUND: Debate remains whether high tibial osteotomy (HTO) or unicompartmental knee arthroplasty (UKA) is more beneficial for the treatment of unicompartmental knee osteoarthritis. The purpose of this study was to compare the functional results, knee scores, activity levels, and complications between the two procedures. METHODS: We performed a systematic review of published literature from August 1982 through January 2017. Fifteen papers reporting three prospective randomized trials were subjected to a meta-analysis...
March 28, 2017: Journal of Orthopaedic Surgery and Research
https://www.readbyqxmd.com/read/28292485/a-cost-effectiveness-analysis-of-reverse-total-shoulder-arthroplasty-versus-hemiarthroplasty-for-the-management-of-complex-proximal-humeral-fractures-in-the-elderly
#14
COMPARATIVE STUDY
Georg Osterhoff, Nathan N O'Hara, Jennifer D'Cruz, Sheila A Sprague, Nick Bansback, Nathan Evaniew, Gerard P Slobogean
BACKGROUND: There is ongoing debate regarding the optimal surgical treatment of complex proximal humeral fractures in elderly patients. OBJECTIVES: To evaluate the cost-effectiveness of reverse total shoulder arthroplasty (RTSA) compared with hemiarthroplasty (HA) in the management of complex proximal humeral fractures, using a cost-utility analysis. METHODS: On the basis of data from published literature, a cost-utility analysis was conducted using decision tree and Markov modeling...
March 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28222649/a-randomized-control-trial-to-evaluate-the-effectiveness-of-intravenous-intra-articular-and-topical-wash-regimes-of-tranexamic-acid-in-primary-total-knee-arthroplasty
#15
Jatin Prakash, Jong-Keun Seon, Yong Jin Park, Cheng Jin, Eun-Kyoo Song
BACKGROUND: The efficacy of tranexamic acid to decrease post-operative blood loss and blood transfusion is well established in literature. However, the ideal mode of administration is debatable. Limited literature has compared all the available modes of administration including intravenous (IV), topical irrigation and retrograde through drain. We hypothesized that no difference would be present in either form of administration of tranexamic acid. METHODS: Fifty patients in four groups were enrolled for study...
January 2017: Journal of Orthopaedic Surgery
https://www.readbyqxmd.com/read/28150224/isolated-acetabular-revision-with-femoral-stem-retention-after-bipolar-hip-arthroplasty
#16
Nobuhiro Kaku, Tomonori Tabata, Hiroaki Tagomori, Hiroshi Tsumura
INTRODUCTION: In bipolar hemiarthroplasty, migration of the outer cup component into the acetabular cup, with evidence of severe osteolysis in the acetabulum, commonly occurs without loosening of the femoral component. The merits of retaining the stable femoral component in these cases have been debated. Our study aimed to determine whether revision of the acetabular component in isolation could be successfully performed. MATERIALS AND METHODS: The data of 54 patients (61 hips), 44 women, and 10 men, aged 67...
March 2017: Archives of Orthopaedic and Trauma Surgery
https://www.readbyqxmd.com/read/28126027/functional-analysis-of-distraction-arthroplasty-in-the-treatment-of-ankle-osteoarthritis
#17
Hongmou Zhao, Wenqing Qu, Yi Li, Xiaojun Liang, Ning Ning, Yan Zhang, Dong Hu
BACKGROUND: Ankle joint distraction arthroplasty (AJDA) is an alternative surgical procedure for the management of moderate to severe ankle osteoarthritis. However, the benefit of this procedure and failure relative factors are still in debate. The purpose of the current study was to evaluate the functional outcomes of AJDA in treatment of moderate to severe ankle OA and to evaluate the relative factors correlated with treatment failure. METHODS: Forty-six van Dijk stages II and III ankle osteoarthritis patients were included...
January 26, 2017: Journal of Orthopaedic Surgery and Research
https://www.readbyqxmd.com/read/28060233/single-anesthetic-versus-staged-bilateral-total-hip-arthroplasty-a-matched-cohort-study
#18
Matthew T Houdek, Cody C Wyles, Chad D Watts, Eric R Wagner, Rafael J Sierra, Robert T Trousdale, Michael J Taunton
BACKGROUND: There is debate regarding the role of single-anesthetic versus staged bilateral total hip arthroplasty (THA) for patients with end-stage bilateral osteoarthritis. Studies have shown that single-anesthetic bilateral THA is associated with systemic complications, but there are limited data comparing patient outcomes in a matched setting of bilateral THA. METHODS: We identified 94 patients (188 hips) who underwent single-anesthetic bilateral THA. Fifty-seven percent of the patients were male...
January 4, 2017: Journal of Bone and Joint Surgery. American Volume
https://www.readbyqxmd.com/read/28002921/restoring-the-femoral-offset-prevent-early-migration-of-the-stem-in-total-hip-arthroplasty-an-ebra-fca-study
#19
G Vicenti, G Solarino, A Spinarelli, M Carrozzo, G Picca, R Maddalena, F Rifino, B Moretti
The use of modular stems is still debated and controversial. Some authors have highlighted a number of disadvantages of modular prostheses including high costs, the tendency to fracture, the fretting and corrosion and the increased production of debris. Other authors have emphasized several advantages to adapt the prosthesis to the morphometric differences of patients, to allow better accuracy in restoring the anatomy and biomechanics of hip joint. The advantages of the modular devices appear to be more evident in patients with developmental dysplasia of the hip (DDH)...
October 2016: Journal of Biological Regulators and Homeostatic Agents
https://www.readbyqxmd.com/read/27999924/low-friction-arthroplasty-and-dual-mobility-cup-a-new-gold-standard
#20
Jean Louis Prudhon, Régis Verdier, Jacques H Caton
INTRODUCTION: Low friction arthroplasty (LFA) introduced by Sir John Charnley was the gold standard for many years. Dislocation and infection are the first causes for early revision. Late failures are polyethylene (PE) wear and loosening. Due to dislocation risk we slowly switched to the use of LFA with dual mobility cups (DMC). The purposes of this study are (1) to assess whether our changes have improved outcomes and (2) what is the new gold standard? MATERIAL AND METHODS: We selected from an observational registry of 1,091 cases of hybrid Charnley total hip arthroplasty (THA)...
March 2017: International Orthopaedics
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