Evidence Based Medicine: Recommendations for Pharmacological Treatment of Osteoarthritis Patients

Nesteroidni antireumatici (NSAR) lijek su izbora u liječenju boli u bolesnika s osteoartritisom (OA). Velik broj različitih NSAR dostupnih na tržištu otežava izbor pojedinoga. Cilj rada: Kritički pregledati tri tipa podataka koji se odnose na NSAR (rezultati istraživanja, kliničko iskustvo i troškovi), radi davanja preporuka kao pomoć pri odlučivanju o terapiji. Materijali i metode: Pretražene su Cochrane, Medline i Embase baze podataka za pregledne članke i kontrolirana randomizirana ispitivanja o kliničkoj djelotvornosti i nuspojavama NSAR. Kliničko iskustvo temelji se na stavovima liječnika-kliničara koautora rada. Podaci o troškovima i prodaji za NSAR odnose se na hrvatsko tržište. Rezultati: Svi NSAR, uključujući i COX-2 selektivne inhibitore, imaju sličnu djelotvornost u kontroli OA boli. Štetni učinak na gornji dio probavnoga trakta najmanji je za diklofenak i ibuprofen, dok za COX-2 selektivne inhibitore, iako vjerojatno manji, nije potpuno utvrđen. Ostale nuspojave rijetko imaju kliničko značenje, a za COX-2 selektivne inhibitore još nisu dovoljno istražene. Dugogodišnje povoljno kliničko iskustvo postoji s diklofenakom i ibuprofenom. Najniži su troškovi liječenja za diklofenak, dok su COX-2 selektivni inhibitori znatno skuplji od neselektivnih NSAR. Zaključak: Diklofenak, a potom ibuprofen ostaju prvi lijek izbora farmakološkog liječenja bolesnika s OA.Non-steroidal anti-inflammatory drugs (NSAIDs) are the treatment of choice for pain control in patients with osteoarthritis (OA). Numerous NSAIDs are available on the market, making a clinical choice difficult. Objective: to review three types of data related to NSAIDs (research results, clinical experience and costs) and thus assist in a clinical decision-making process. Materials and methods: We searched Cochrane, Medline and Embase for systematic reviews and randomized controlled trials about clinical efficacy and side effects of NSAIDs. Clinical experience is based on the opinion of clinicians, i.e. the coauthors of this paper. Costs and sales statistics were obtained for the Croatian drug market. Results: All NSAIDs, including the new selective COX-2 inhibitors, have similar efficacy in controlling the OA pain. Toxicity on upper gastrointestinal tract is the lowest for diclofenac and ibuprofen, whilst for selective COX-2 inhibitors, although probably lower, has not been fully established. Other side effects are rarely clinically relevant and they have not been elucidated for COX-2 inhibitors. There is a long-term favorable clinical experience with the use of diclofenac and ibuprofen. The costs are the lowest for diclofenac, while COX-2 inhibitors are much more expensive than non-selective NSAIDs. Conclusion: Diclofenac, followed by ibuprofen, remains the drug of choice in the pharmacological treatment of OA patients

Predictors of treatment outcomes in geriatric patients with odontoid fractures: AOSpine North America multi-centre prospective GOF study.

STUDY DESIGN: Multicenter prospective cohort study. OBJECTIVE: To identify patient and treatment characteristics associated with treatment success or failure in the management of odontoid fractures. SUMMARY OF BACKGROUND DATA: Odontoid fractures are the most common cervical spine fractures in the elderly and represent a significant management challenge with widely divergent views regarding operative versus nonoperative management. METHODS: A total of 159 patients 65 years and older with radiographically confirmed type II odontoid fractures were enrolled at 10 sites in the United States and 1 site in Canada between January 2006 and May 2009. Subjects were followed at 6 and 12 months post-initial treatment with Neck Disability Index and SF-36v2 scores. Final treatment outcome was classified as failure or success. Treatment failure was defined as death by any cause, decline in Neck Disability Index by more than 9.5 absolute points, or occurrence of a major treatment-related complication. Baseline characteristics between the groups were compared using t test for the continuous variables and χ2 test for the categorical variables. Baseline characteristics associated with treatment outcomes were identified by multiple logistic stepwise regression analysis. RESULTS: A total of 101 (63.5%) patients were treated surgically and 58 (36.5%) conservatively. Forty-four (27.7%) patients had a successful outcome and 86 (54.1%) had a treatment failure; for 29 patients (18.2%), treatment status could not be determined (3 withdrew; 26 were lost to follow-up). Twenty-nine (18.2%) patients expired before the 12-month follow-up. Follow-up information was available for 103 of 127 surviving (81.1%) patients. Twelve-month SF-36v2 scores were worse in the failure group. The characteristics associated with treatment failure were older age (odds ratio [OR] = 1.08 for each year of age); initial nonsurgical treatment (OR = 3.09); male sex (OR = 4.33), and baseline neurological system comorbidity (OR = 4.13). CONCLUSION: Older age, initial nonsurgical treatment, and male sex are associated with failure of treatment in patients with geriatric odontoid fractures

The AOSpine North America Geriatric Odontoid Fracture Mortality Study: A Retrospective Review of Mortality Outcomes for Operative Versus Nonoperative Treatment of 322 Patients With Long-Term Follow-up.

STUDY DESIGN.: Retrospective, multicenter cohort study. OBJECTIVE.: Assess for differences in short- and long-term mortality between operative and nonoperative treatment for elderly patients with type II odontoid fractures. SUMMARY OF BACKGROUND DATA.: There is controversy regarding whether operative or nonoperative management is the best treatment for elderly patients with type II odontoid fractures. METHODS.: This is a retrospective study of consecutive patients aged 65 years or older with type II odontoid fracture from 3 level I trauma centers from 2003-2009. Demographics, comorbidities, and treatment were abstracted from medical records. Mortality outcomes were obtained from medical records and a public database. Hazard ratios (HRs) and 95% confidence intervals (CI) were calculated. RESULTS.: A total of 322 patients were included (mean age, 81.8 yr; range, 65.0-101.5 yr). Compared with patients treated nonoperatively (n = 157), patients treated operatively (n = 165) were slightly younger (80.4 vs. 83.2 yr, P = 0.0014), had a longer hospital (15.0 vs. 7.4 d, P \u3c 0.001) and intensive care unit (1.5 vs. 1.1 d, P = 0.008) stay, and were more likely to receive a feeding tube (18% vs. 5%, P = 0.0003). Operative and nonoperative treatment groups had similar sex distribution (P = 0.94) and Charlson comorbidity index (P = 0.11). Within 30 days of presentation, 14% of patients died, and at maximal follow-up (average = 2.05 yr; range = 0 d-7.02 yr), 44% had died. On multivariate analysis, nonoperative treatment was associated with higher 30-day mortality (HR = 3.00, 95% CI = 1.51-5.94, P = 0.0017), after adjusting for age (HR = 1.10, 95% CI = 1.05-1.14; P \u3c 0.0001), male sex (P = 0.69), and Charlson comorbidity index (P = 0.16). At maximal follow-up, there was a trend toward higher mortality associated with nonoperative treatment (HR = 1.35, 95% CI = 0.97-1.89, P = 0.079), after adjusting for age (HR = 1.07, 95% CI = 1.05-1.10; P \u3c 0.0001), male sex (HR = 1.55, 95% CI = 1.10-2.16; P = 0.012), and Charlson comorbidity index (HR = 1.28, 95% CI = 1.16-1.40; P \u3c 0.0001). CONCLUSION.: Surgical treatment of type II odontoid fracture in this elderly population did not negatively impact survival, even after adjusting for age, sex, and comorbidities. The data suggest a significant 30-day survival advantage and a trend toward improved longer-term survival for operatively treated over nonoperatively treated patients.Level of Evidence: 4

Mid-term outcomes of the R3™ delta ceramic acetabular system in total hip arthroplasty

BackgroundWhilst bony fixation of hip replacement has stable solutions, there remains controversy over which bearing best optimizes longevity and function. Ceramic-on-ceramic (CoC) bearing combinations are associated with lower risk of revision due to aseptic loosening and dislocation. Evidence for long-term functional outcomes of modern, 4th generation CoC bearings is limited. The aim of this study was to analyze outcomes and complications of the R3 (TM) Acetabular System (Smith & Nephew, Inc., Cordova, TN, USA) in combination with BIOLOX (R) Delta ceramic femoral head in patients undergoing primary total hip arthroplasty (THA).MethodsBetween June 2009 and May 2011, 175 patients (178 hips) were enrolled into a prospective, study at 6 sites in Europe and prospectively followed-up at 3 months and 1, 3, 5, and 7 years postoperative.ResultsTotal WOMAC score improved from 63 (range, 22-91) preoperative to 8 (range, 0-8) at 1-year follow-up and remained unchanged at 7-year follow-up. Modified Harris hip score improved from 45 (range, 10-87) preoperative to 83 (range, 25-100) at 3 months, 91 (range, 42-100) at 1 year, and 92 (range, 46, 100) at 7 years. UCLA Activity Rating Scale score improved from 3.3 (range, 1-8) preoperative to 6.2 (range, 2-8) at 1 year; it marginally declined to 5.8 (range, 3-8) at 7-year follow-up. There were 4 trochanteric fractures and 5 patients died of unrelated reasons. Three hips were revised (2 periprosthetic fractures and 1 subluxation). The 7-year cumulative survival rate was 98.3%.ConclusionClinical and functional improvements of THA with CoC bearing are maintained at 7 years postoperative.Trial registrationClinicalTrials.Gov, NCT03566082, Registered 10 January 2018-retrospectively registered

Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture.

BACKGROUND: Dens fractures are relatively common in the elderly. The treatment of Type-II dens fractures remains controversial. The aim of this multicenter prospective cohort study was to compare outcomes (assessed with use of validated clinical measures) and complications of nonsurgical and surgical treatment of Type-II dens fractures in patients sixty-five years of age or older. METHODS: One hundred and fifty-nine patients with a Type-II dens fracture were enrolled in a multicenter prospective study. Subjects were treated either surgically (n = 101) or nonsurgically (n = 58) as determined by the treatment preferences of the treating physicians and the patients. The subjects were followed at six and twelve months with validated outcome measures, including the Neck Disability Index (NDI) and Short Form-36v2 (SF-36v2). Treatment complications were prospectively recorded. Statistical analysis was performed to compare outcome measures before and after adjustment for confounding variables. RESULTS: The two groups were similar with regard to baseline characteristics. The most common surgical treatment was posterior C1-C2 arthrodesis (eighty of 101, or 79%) while the most common nonsurgical treatment was immobilization with use of a hard collar (forty-seven of fifty-eight, or 81%). The overall mortality rate was 18% over the twelve-month follow-up period. At twelve months, the NDI had increased (worsened) by 14.7 points in the nonsurgical cohort (p \u3c 0.0001) compared with a nonsignificant increase (worsening) of 5.7 points in the surgical group (p = 0.0555). The surgical group had significantly better outcomes as measured by the NDI and SF-36v2 Bodily Pain dimension compared with the nonsurgical group, and these differences persisted after adjustment. There was no difference in the overall rate of complications, but the surgical group had a significantly lower rate of nonunion (5% versus 21% in the nonsurgical group; p = 0.0033). Mortality was higher in the nonsurgical group compared with the surgical group (annual mortality rates of 26% and 14%, respectively; p = 0.059). CONCLUSIONS: We demonstrated a significant benefit with surgical treatment of dens fractures as measured by the NDI, a disease-specific functional outcome measure. As a result of the nonrandomized nature of the study, the results are vulnerable to the effects of possible residual confounding. We recommend that elderly patients with a Type-II dens fracture who are healthy enough for general anesthesia be considered for surgical stabilization to improve functional outcome as well as the union and fusion rates

Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion

Study design: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. Objective: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone. Methods: Between 2006 and 2013, 319 individuals with single-level degenerative disc disease (DDD) and no previous fusion at the index level underwent ACDF. The presence of diabetes determined the 2 cohorts. Data collected included radiological fusion evaluation, neurological outcomes, Neck Disability Index (NDI), Visual Analog Scale (VAS) scores, and the 36-Item Short Form Survey Version 2 (SF-36v2) Physical and Mental component summary scores. Results: There were 35 individuals with diabetes (11.1%; average body mass index [BMI] = 32.99 kg/m2; SD = 5.72) and 284 without (average BMI = 28.32 kg/m2; SD = 5.67). The number of nondiabetic smokers was significantly higher than diabetic smokers: 73 (25.70%) and 3 (8.57%), respectively. Preoperative scores of NDI, VAS arm pain, and SF-36v2 were similar between the diabetic and nondiabetic participants at baseline; however, VAS neck pain differed significantly between the cohorts at baseline (P = .0089). Maximum improvement for NDI, VAS neck and arm pain, and SF-36v2 PCS and MCS scores was seen at 6 months in both cohorts and remained stable until 24 months. Conclusions: ACDF is effective for cervical radiculopathy in patients with diabetes. Diabetes is not a contraindication for patients requiring single-level surgery for cervical DDD

Lipid and Lipoprotein Contents of Human Follicular Fluid

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