Mitigating Biases in a Cohort Study: A Critical Examination of the Silicone Arthroplasty in Rheumatoid Arthritis Study.

Research bias, or the systematic errors of a study, can arise before, during, or after a trial ends. These biases hinder the internal validity of the study, which is the accuracy of a study's conclusions regarding the effects of an intervention on a given group of subjects. With the growing use of evidence-based medicine, there is a demand for high-quality evidence from the research community. Systematic reviews and meta-analyses of randomized controlled trials are considered the highest level of evidence, followed by individual randomized controlled trials. However, most surgical trials cannot be conducted as randomized controlled trials because of factors such as patient preferences and lack of equipoise among surgeons. Therefore, surgical trials may lack features that are held as important standards for high-quality evidence, such as randomization and blinding. To demonstrate the biases that surgical trials may encounter, the authors examined a prospective cohort study, the Silicone Arthroplasty in Rheumatoid Arthritis study. The authors focus on the challenges that arise during a surgical trial, including the design, implementation, and methods used to report the clinical evidence. By recognizing and addressing obstacles that exist in research, investigators will provide health care providers with high-quality evidence needed to make well-informed, evidence-based clinical decisions.

Pathology Assessment of Femoral Head Resection Specimens: An Important Quality Assurance Procedure.

CONTEXT.­: Decisions to perform hip arthroplasty rely on both radiographic and clinical findings. Radiologists estimate degree of osteoarthritis (OA) and document other findings. Arthroplasty specimens are sometimes evaluated by pathology. OBJECTIVE.­: To determine the frequency of pathologic changes not recognized clinically. DESIGN.­: Nine hundred fifty-three consecutive femoral head resections performed between January 2015 and June 2018, with recent radiologic and histologic study, were reviewed. We compared severity of OA reported by radiology and pathology. Findings unrecognized radiographically but recorded pathologically, and discrepancies between clinical diagnosis and pathology diagnosis, were tabulated. RESULTS.­: Twenty-one cases of osteomyelitis were diagnosed radiographically or pathologically. Eight discrepancies were present. Fourteen osteomyelitis cases were recognized clinically. Pathology recognized 2 neoplasms missed radiographically. Avascular necrosis was diagnosed on pathology but not radiology in 25 cases, and 35 cases of avascular necrosis were seen radiographically but not pathologically. Osteoarthritis was graded both radiographically and pathologically from 0 to 3. Five hundred ninety-one of 953 cases (62%) were grade 3. Pathologists and radiologists had perfect agreement in 696 of 953 cases (73%). When grade of OA seen at pathology was correlated with surgeon, 2 groups of surgeons were detected: one with a low threshold for performance of hip arthroplasty (23%-28% low-severity OA) and the second with a high threshold (2%-5% low-severity OA). CONCLUSIONS.­: Correlation between radiology and pathology diagnoses is high. Degree of OA present varies significantly between surgeons. Pathology discloses findings not recognized clinically.

Single-tunnel anatomic double-bundle anterior cruciate ligament reconstruction has the same effectiveness as double femoral, double tibial tunnel: A prospective randomized study.

PURPOSE: To investigate whether single femoral, single tibial tunnel anatomic double-bundle anterior cruciate ligament (ACL) reconstruction is equal to or superior to double femoral, double tibial tunnel ACL double-bundle anatomic reconstruction in terms of restoring the stability and functions of the knee joint. METHODS: A prospective clinical study was performed to compare 30 cases of single-tunnel ACL double-bundle anatomic reconstruction to 28 cases of double-tunnel ACL double-bundle anatomic reconstruction, with average follow-up of 36 months. All graft tendons were hamstring tendon autografts. Tunnel placements in all the cases were made anatomically. Clinical results were collected after reconstruction. Graft appearance, meniscus status and cartilage state under arthroscopy were compared and analyzed. RESULTS: Tunnel placements were in the anatomic positions in both groups. On the lateral pivot-shift test performed at 36 months postoperatively, there was no significant difference between groups. Clinical results such as International Knee Documentation Committee score, Tegner activity scale, and range of motion showed no significant differences between the groups. The mean thickness of anteromedial graft was reduced by 10.3% and that of the posterolateral graft was reduced by 11.1% from the original graft thickness evaluated by magnetic resonance imaging. No new meniscal tears were found either group; however, cartilage damage occurred in the double-tunnel group at 39.3%, and this rate was significantly higher than that in the single-tunnel group (10.0%). CONCLUSION: Single femoral, single tibial tunnel anatomic double-bundle ACL reconstruction has the same effectiveness as the double femoral, double tibial tunnel in restoring the knee's stability and functions.

Limited reliability of grading scapular notching according to Nerot-Sirveaux on anteroposterior radiographs.

INTRODUCTION: Incidences of scapular notching (SN) in reverse shoulder arthroplasty (RSA) range between 0% and 96%, and controversy remain as to its relevance for patient outcome. We assessed the reliability of scapular notching (SN) grading based on the Sirveaux classification system using anteroposterior radiographs. MATERIALS AND METHODS: 206 RSA procedures with 5-year postoperative anteroposterior shoulder radiographs were classified independently by seven assessors according to Sirveaux (session 1). After a review meeting, three assessors re-classified the radiographs along with quality criteria (session 2). SN grading by the majority of assessors was taken as the reference. Classification interobserver reliability was analyzed using Kappa statistics. RESULTS: The incidence of SN was estimated at 53% and 37% at the first and second sessions, respectively. Interobserver reliability Kappa coefficients resulting from the first and second sessions were 0.27 and 0.43, respectively. Case selection based on radiographic quality criteria did not improve SN grading reliability in the second session. CONCLUSION: Agreement between individual surgeons was low when grading SN in RSA according to Sirveaux using anteroposterior radiographs. Consensus among several assessors may increase reliability in research settings.

Shoulder arthroplasty volume standards: the more the better?

INTRODUCTION: The wide use of hip and knee arthroplasty has led to implementation of volume standards for hospitals and surgeons. For shoulder arthroplasty, the effect of volume on outcome has been researched, but no volume standard exists. This review assessed literature reporting on shoulder arthroplasty volumes and its relation to patient-reported and functional outcomes to define an annual volume threshold. MATERIALS AND METHODS: MEDLINE and EMBASE were searched for articles published until February 2018 reporting on the outcome of primary shoulder arthroplasty in relation to surgeon or hospital volume. The primary outcome was predefined as any patient-reported outcome. The secondary outcome measures were length of stay, costs, rates of mortality, complications, readmissions, and revisions. A meta-analysis was performed for outcomes reported by two or more studies. RESULTS: Eight retrospective studies were included and did not consistently show any associations of volume with in-hospital complications, revision, discharge to home or cost. Volume was consistently associated with length of stay (shorter length of stay for higher volume) and in-hospital complications (fewer in-hospital complications for higher volume). It was not consistently associated with mortality. Functional outcomes were not reported. CONCLUSIONS: There is insufficient evidence to support the concept that only the number of shoulder arthroplasties annually performed (either per hospital or per surgeon) results in better patient-reported and functional outcomes. Currently, published volume thresholds are only based on short-term parameters such as length and cost of hospital stay.

A Comparison of Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion in Patients with Two-Level Cervical Degenerative Disc Disease: 5-Year Follow-Up Results.

OBJECTIVE: To present a long-term clinical and radiographic comparison between the Prestige LP cervical disc replacement and the Zero-P spacer cervical disc fusion in the treatment of patients with symptomatic 2-level cervical degenerative disease. METHODS: In total, 36 patients in the anterior cervical discectomy and fusion (ACDF) group and 24 patients in the cervical disc arthroplasty (CDA) group were analyzed before surgery and at 1 week and 3, 6, 12, 24, and 60 months after surgery. Clinical assessments included the Japanese Orthopaedic Association score, visual analog scale, and Neck Disability Index scores. Radiographic assessments included cervical lordosis, range of motion (ROM) of the total cervical spine, functional spinal unit (FSU), and superior and inferior adjacent segments. Complications including heterotopic ossification and adjacent-segment degeneration (ASD) at 5-year follow-up were collected as well. RESULTS: Mean follow-up period was 65.6 months. Both the ACDF and CDA groups showed significant clinical improvements in terms of Japanese Orthopaedic Association score, visual analog scale, and Neck Disability Index (P < 0.05), but there was no significant difference between groups at the last follow-up period. A significant increase of cervical lordosis was observed in the CDA group after surgery whereas a significant difference was not observed between groups. ROM of the total cervical spine and FSU were maintained during the follow-up, and a significant decrease was observed in the ACDF group after surgery (P < 0.05). The ROM of the superior adjacent segment did not show any difference whereas the ROM of the inferior adjacent segment in the ACDF group presented a significant increase at 6 months and 1 year after surgery and a significant decrease at the last follow-up period. A total of 8 (33.3%) patients in the CDA group had an occurrence of heterotopic ossification. ASD was observed in 2 (8.3%) patients who underwent CDA surgery and 8 (22.2%) patients who underwent ACDF surgery. CONCLUSIONS: The use of the Prestige-LP and ZERO-P Spacer implantations is safe and effective. At 5 years after surgery, CDA with Prestige-LP is superior in terms of ROM of the total cervical spine, FSU, and inferior adjacent segment. It also has a relatively low occurrence rate of ASD. This procedure may be a suitable choice for the treatment of contiguous 2-level CDDD.

Establishing a Successful Outpatient Joint Arthroplasty Program.

Many surgical procedures are performed in outpatient settings, and outpatient joint replacements are one of the emerging trends in orthopedics. Rising consumer demand for value-driven health care, new technology, and pain management advancements, and more physicians training in minimally invasive surgical techniques during their residency have driven this change. When a facility is considering the establishment of an outpatient joint arthroplasty program, leaders must take into consideration the outcomes data from the facility's current joint arthroplasty program. Additional factors in establishing a successful outpatient program include careful patient selection, preoperative patient education, the presence of a case manager, and specialized protocols and techniques.

Rate of Adjacent Segment Degeneration of Cervical Disc Arthroplasty Versus Fusion Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The concern of adjacent segment disease (ASD) has led to the development of motion-preserving technologies, such as cervical disc arthroplasty (CDA). However, there is still controversy whether CDA is superior to anterior cervical decompression and fusion (ACDF) as to the incidence of ASD. The purpose of this study is to evaluate the rate of ASD between CDA and ACDF. METHODS: Systematic searches of all relevant studies through November 2017 were identified from the Cochrane Library, PubMed, Embase, and CNKI. Randomized controlled trials comparing the clinical effectiveness of CDA and ACDF for cervical degenerative disc disease (DDD) were included. Two independent reviewers searched and assessed all literature according to the standard of Cochrane systematic review. Data extraction and quality assessment were conducted, and RevMan 5.2 was used for data analysis. The random effects model was used if there was heterogeneity between studies; otherwise, the fixed effects model was used. RESULTS: Twenty-one studies were included in our meta-analysis. The pooled data revealed that the CDA group had significantly lower adjacent segment diseases than the ACDF group did. Furthermore, there were fewer adjacent segment reoperations in the CDA group compared with the ACDF group. CONCLUSIONS: In this meta-analysis, we conclude that CDA was better than the ACDF in terms of ASD and adjacent segment reoperations. This conclusion suggests that CDA is a superior alternative invention for the treatment of cervical DDD to preserve cervical range of motion and reduce the risk of ASD; however, this requires further validation and investigation in larger sample-size prospective and randomized studies with long-term follow-up.

Long-Term Results of a Monocentric Series of Soldiers After Latarjet Procedure for Anterior Shoulder Instability. Implications for the Assessment of Soldiers' Medical Ability.

Introduction: Stabilizing surgery of the shoulder with a coracoid graft according to Latarjet is a recognized surgical treatment for anterior instability of the shoulder. This pathology frequently affects soldiers. Postoperatively, the potential risk of recurrence or of secondary shoulder arthritis can limit the practitioner in their ability assessment. The aim of this study is to analyze the long-term outcomes of this surgery in a military population, in order to assess the possible implications for French soldiers' medical ability. Material and Methods: Twenty soldiers operated on the shoulder by Latarjet procedure by the same surgeon were retrospectively reviewed after more than 15 yr. All of them did regular physical activity for leisure or competitions. None had preoperative osteoarthritis injuries. The number of dislocation recurrences, the functional score, and the rate of radiographic osteoarthritis were assessed. Results: After more than 16.3 yr (extremes: 15-24 yr), none displayed a dislocation recurrence. The average Rowe's score was 91.8 ± 9.9. The average subjective shoulder value was 89.2 ± 9.7. All patients had resumed sport. Three of them developed level 1 or 2 radiological signs of osteoarthritis according to Samilson. No level 3 or 4 osteoarthritis was found. Among all the patients, 14 still did regular physical activity. Discussion: In view of our results and of those from the literature, the results of treatment for anterior shoulder instability with the Latarjet procedure are good, even very good in the long term. These data must be considered to favor this procedure for soldiers with shoulder instability and from a medico-administrative viewpoint for military patients in order to pursue their careers without any job restrictions.

The minimum follow-up required for radial head arthroplasty: a meta-analysis.

AIMS: The primary aim of this study was to define the standard minimum follow-up required to produce a reliable estimate of the rate of re-operation after radial head arthroplasty (RHA). The secondary objective was to define the leading reasons for re-operation. MATERIALS AND METHODS: Four electronic databases, between January 2000 and March 2017 were searched. Articles reporting reasons for re-operation (Group I) and results (Group II) after RHA were included. In Group I, a meta-analysis was performed to obtain the standard minimum follow-up, the mean time to re-operation and the reason for failure. In Group II, the minimum follow-up for each study was compared with the standard minimum follow-up. RESULTS: A total of 40 studies were analysed: three were Group I and included 80 implants and 37 were Group II and included 1192 implants. In Group I, the mean time to re-operation was 1.37 years (0 to 11.25), the standard minimum follow-up was 3.25 years; painful loosening was the main indication for re-operation. In Group II, 33 Group II articles (89.2%) reported a minimum follow-up of < 3.25 years. CONCLUSION: The literature does not provide a reliable estimate of the rate of re-operation after RHA. The reproducibility of results would be improved by using a minimum follow-up of three years combined with a consensus of the definition of the reasons for failure after RHA. Cite this article: Bone Joint J 2017;99-B:1561-70.

Accuracy assessment of measuring component position after total ankle arthroplasty using a conventional method.

BACKGROUND: This study was to assess the accuracy of measuring the tibial and talar components position and to investigate the outlier rate of each component and predisposing factors related to component malalignment after total ankle arthroplasty (TAA) using a conventional method. METHODS: One hundred fifty consecutive primary total ankle arthroplasty were performed using the three-component HINTEGRA prosthesis for ankle end-stage osteoarthritis. Radiographic analysis for the accuracy of component position in coronal and sagittal plane was conducted at postoperative 6 months. Additionally, the accuracy of component position was evaluated according to presence of preoperative deformity or joint incongruency. RESULTS: The mean postoperative coronal angles of the tibial and talar components (α and γ) were 91.9° and 91.3°. The mean postoperative sagittal angles of the tibial and talar components (ß and δ angle) were 84.6° and 91.7°. In the coronal plane, 16 (10.7%) tibial components and 15 (10.0%) talar components showed outliers greater than 5°. In sagittal plane, 15 (10.0%) tibial components and 29 (19.3%) talar components showed outliers greater than 5°. There was no meaningful increase of the outlier rate regarding presence of preoperative deformity or joint incongruency. CONCLUSIONS: In conventional method of TAA, the outlier rate of the tibial and talar components was about 10 to 20%, especially, the outlier rate of talar component in sagittal plane was up to 20%. Therefore, careful attention should be paid to implant the talar component in conventional TAA.

Reporting the results of meta-analyses: a plea for incorporating clinical relevance referring to an example.

BACKGROUND CONTEXT: The results of meta-analyses are frequently reported, but understanding and interpreting them is difficult for both clinicians and patients. Statistical significances are presented without referring to values that imply clinical relevance. PURPOSE: This study aimed to use the minimal clinically important difference (MCID) to rate the clinical relevance of a meta-analysis. STUDY DESIGN: This study is a review of the literature. PATIENT SAMPLE: This study is a review of meta-analyses relating to a specific topic, clinical results of cervical arthroplasty. OUTCOME MEASURE: The outcome measure used in the study was the MCID. METHODS: We performed an extensive literature search of a series of meta-analyses evaluating a similar subject as an example. We searched in Pubmed and Embase through August 9, 2016, and found articles concerning meta-analyses of the clinical outcome of cervical arthroplasty compared with that of anterior cervical discectomy with fusion in cases of cervical degenerative disease. We evaluated the analyses for statistical significance and their relation to MCID. MCID was defined based on results in similar patient groups and a similar disease entity reported in the literature. RESULTS: We identified 21 meta-analyses, only one of which referred to MCID. However, the researchers used an inappropriate measurement scale and, therefore, an incorrect MCID. The majority of the conclusions were based on statistical results without mentioning clinical relevance. CONCLUSIONS: The majority of the articles we reviewed drew conclusions based on statistical differences instead of clinical relevance. We recommend introducing the concept of MCID while reporting the results of a meta-analysis, as well as mentioning the explicit scale of the analyzed measurement.

Patient Outcomes as a Function of Shoulder Surgeon Volume: A Systematic Review.

PURPOSE: To examine surgical complications, length of stay, surgical time, cost, revision rates, clinical outcomes, current surgical trends. and minimum number of cases in relationship to surgeon volume for shoulder arthroplasty and rotator cuff repair. METHODS: We performed a systematic review of studies using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All studies that met inclusion criteria from January 1990 to January 2016 were included. Inclusion criteria included Level IV evidence or greater, contained specific surgeon volume, and were written in or translated into English. Exclusion criteria included non-English manuscripts, abstracts, and review papers. A written protocol was used to extract relevant data and evaluate study results. Data extracted included volume-specific data pertaining to length of stay, operating time, complications, and cost. RESULTS: A total of 10 studies were included. Seven studies evaluated arthroplasty with 88,740 shoulders, and 3 studies evaluated rotator cuff repair with 63,535 shoulders. Variation was seen in how studies defined low- versus high-volume surgeon. For arthroplasty, <5 cases per year met the criteria for a low-volume surgeon and were associated with increased length of stay, longer operating room time, increased in-hospital complications, and increased cost. Mortality was not significantly increased. In rotator cuff surgery, <12 surgeries per year met the criteria for low volume and were associated with increased length of stay, increased operating room time, and increase in reoperation rate. CONCLUSIONS: Our systematic review demonstrates increased surgical complications, length of stay, surgical time, and surgical cost in shoulder arthroplasty and rotator cuff repair when performed by a low-volume shoulder surgeon, which is defined by those performing <5 arthroplasties and/or <12 rotator cuff repairs per year. LEVEL OF EVIDENCE: Level III, systematic review of Level II and III studies.

The Patient Experience: An Analysis of Orthopedic Surgeon Quality on Physician-Rating Sites.

BACKGROUND: With the advent of the Consensus Core of Orthopedic Measures, arthroplasty surgeons are increasingly subjected to public performance reviews on physician-rating sites. Therefore, we evaluated (1) web site details of physician-rating sites, (2) differences between sites and the Consensus Core, (3) published patient experiences, (4) search rank among sites, and (5) differences between academic vs nonacademic and arthroplasty vs nonarthroplasty surgeons. METHODS: The 5 busiest physician-rating sites were analyzed. To compare physician-rating sites to the Consensus Core, 3 reviewers analyzed the web site details. To evaluate patient ratings and reviews, orthopedists from the top 5 academic and nonacademic hospitals (2016 US News & World Report) were analyzed. Institution-produced rating sites were also analyzed. Findings were stratified between academic vs nonacademic and arthroplasty vs nonarthroplasty surgeons. Five hundred and six staff surgeons across 10 academic and nonacademic affiliated hospitals yielded 27,792 patient-generated ratings and reviews for 1404 accounts. RESULTS: Features on all sites were practice location, languages spoken, and patient experience. Two sites autogenerated profiles of surgeons without consent. No physician-rating site contained all Consensus Core domains. The composite orthopedic surgeon rating was 4.1 of 5. No significant differences were found between academic and nonacademic affiliated surgeons. Arthroplasty surgeons had a greater number of reviews and ratings on 2 sites. CONCLUSION: Reliability of physician-rating sites is questionable, as none contained all Consensus Core domains. Autogeneration of surgeon profiles is occurring, and no differences between academic vs nonacademic or arthroplasty vs nonarthroplasty surgeons were found. Institution-produced sites may serve to better promote and market surgeons.

Use of a computerized arthroplasty registry to generate operative reports decreases transcription errors.

OBJECTIVES: Despite the clear importance of the operative report in the electronic medical record, few studies have addressed the quality. METHODS: We prospectively evaluated 300 consecutive patients undergoing primary total joint arthroplasties for operative report errors utilizing three different forms of documentation (standard dictation vs. templated dictation vs. a computer registry database generated operative report). The three types of reports were evaluated for errors which were classified as either major or minor. RESULTS: There were significantly more total errors in the standard dictation group compared to both the computer registry database generated (p<0.001) and the templated operative reports (p<0.001). Major errors were significantly reduced in the database generated reports compared to the templated (p<0.001) and standard dictation groups (p<0.001). There were significantly more minor errors in the standard dictation group (p<0.001) compared to the other two groups. No statistically significant differences in major errors were noted when comparing standard vs. templated operative reports. There was no difference in minor or total errors between the database generated and templated operative reports. CONCLUSIONS: The use of a computer registry database generated operative report resulted in fewer major errors versus a templated or standard dictated operative report. Further research is warranted in this area to validate these findings across subspecialties and institutions.

Total Joint Arthroplasty Patients' Education on Financial Issues and Its Connection to Reported Out-of-Pocket Costs-A European Study.

PURPOSE: Total joint arthroplasty is accompanied by significant costs. In nursing, patient education on financial issues is considered important. Our purpose was to examine the possible association between the arthroplasty patients' financial knowledge and their out-of-pocket costs. METHODS: Descriptive correlational study in five European countries. Patient data were collected preoperatively and at 6 months postoperatively, with structured, self-administered instruments, regarding their expected and received financial knowledge and out-of-pocket costs. FINDINGS: There were 1,288 patients preoperatively, and 352 at 6 months. Patients' financial knowledge expectations were higher than knowledge received. Patients with high financial knowledge expectations and lack of fulfillment of these expectations had lowest costs. CONCLUSION: There is need to establish programs for improving the financial knowledge of patients. Patients with fulfilled expectations reported higher costs and may have followed and reported their costs in a more precise way. In the future, this association needs multimethod research.

Novedades en artroplastia de hombro en 2015 / Update in shoulder surgery 2015: arthroplasty

La indicación en la cirugía de sustitución protésica del hombro ha cambiado de una forma drástica en los últimos años, hemos pasado del tratamiento con prótesis parciales para fracturas agudas al uso de prótesis inversas, la prótesis anatómica ha perdido terreno hasta el punto de que en muchos hospitales la prótesis invertida ha superado con creces a la prótesis anatómica. También podemos decir que las indicaciones de prótesis han variado, así hemos ampliado el uso de la prótesis inversa que fue desarrollada para el tratamiento de las artropatías por manguito rotador. Estos implantes en la actualidad se usan además como recurso para fracturas y recambios. En este artículo intentamos hacer una puesta al día de los problemas más frecuentes de las artroplastias y además se hace una revisión de lo publicado en los últimos años haciendo mayor hincapié en los artículos publicados en el JSES, JBJS y los ICL de la AAOS. De forma resumida se valoran las complicaciones que afectan a las prótesis de hombro

Changes in replacement surgery in the shoulder have happened recently: reverse shoulder prosthesis for acute fractures, and more indications for reverse shoulder arthroplasty than before. In this paper an update of most frequent concepts in shoulder surgery during 2015 is performed