Predictors of Persistent Post-Surgical Pain Following Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of Observational Studies.

OBJECTIVE: Approximately one in four total knee replacement patients develop persistent pain. Identification of those at higher risk could help inform optimal management. METHODS: We searched MEDLINE, EMBASE, CINAHL, AMED, SPORTDiscus, and PsycINFO for observational studies that explored the association between risk factors and persistent pain (≥3 months) after total knee replacement. We pooled estimates of association for all independent variables reported by >1 study. RESULTS: Thirty studies (26,517 patients) reported the association of 151 independent variables with persistent pain after knee replacement. High certainty evidence demonstrated an increased risk of persistent pain with pain catastrophizing (absolute risk increase [ARI] 23%, 95% confidence interval [CI] 12 to 35), younger age (ARI for every 10-year decrement from age 80, 4%, 95% CI 2 to 6), and moderate-to-severe acute post-operative pain (ARI 30%, 95% CI 20 to 39). Moderate certainty evidence suggested an association with female sex (ARI 7%, 95% CI 3 to 11) and higher pre-operative pain (ARI 35%, 95% CI 7 to 58). Studies did not adjust for both peri-operative pain severity and pain catastrophizing, which are unlikely to be independent. High to moderate certainty evidence demonstrated no association with pre-operative range of motion, body mass index, bilateral or unilateral knee replacement, and American Society of Anesthesiologists score. CONCLUSIONS: Rigorously conducted observational studies are required to establish the relative importance of higher levels of peri-operative pain and pain catastrophizing with persistent pain after knee replacement surgery.

Robotic thoracic surgery in Canada: Are patients willing to pay out of pocket?

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective, but is associated with high capital and operating costs that are not reimbursed by the Canadian government. Currently, patients have access to RTS only when it is supported by research or philanthropic funds. In a recent study, we assessed the extent of patient-reported satisfaction with RTS, whether patients would have been willing to pay out of pocket for it, and what factors were associated with patients' willingness to pay. Many patients (290 of 411 [70.56%]) stated that they would have paid the additional $2000 to supplement the government health care coverage to have access to RTS. Factors found to be significantly associated with participants' willingness to pay were an annual income of $60 000 or more (p = 0.034), private insurance coverage (p = 0.007), overall experience with RTS rated as 8 or higher out of 10 (p < 0.001), and overall postoperative postdischarge experience rated as satisfying or very satisfying (p = 0.004).

Braking Time Following Total Knee Arthroplasty: A Systematic Review.

BACKGROUND: Currently, no guidelines exist to assist surgeons in providing recommendations to patients undergoing total knee arthroplasty (TKA) on when it is safe to return to driving. The purpose of this systematic review is to analyze the best available literature to assist surgeons in providing evidence-based recommendations on when it is safe to return to driving after TKA. METHODS: Following established methodology for the conduct of systematic reviews, a literature search was performed for prospective studies on driving after TKA. Two reviewers screened citations for inclusion, assessed methodological quality, and extracted data. RESULTS: Nine studies with 330 subjects met the inclusion criteria. Normalization of brake response time, movement time, and reaction time to preoperative baseline was assessed by pooling data across studies between 0 and 4 weeks and >4 weeks after TKA. Patients who underwent left TKA and right TKA showed normalization by 2 and 4 weeks, respectively. The limited studies that evaluated brake response time, movement time, and reaction time prior to 2 weeks postoperatively also showed normalization to preoperative levels. CONCLUSION: Patients with right TKA have normalization of braking time by 4 weeks, and normalization is as early as 2 weeks following left TKA. Surgeons must consider these recommendations and other patient factors that determine fitness to drive prior to deeming a patient safe to return to driving.

Robot-assisted partial knee replacement versus standard total knee replacement (RoboKnees): a protocol for a pilot randomized controlled trial.

BACKGROUND: Total knee arthroplasty is a common surgery for end-stage knee osteoarthritis. Partial knee arthroplasty is also a treatment option for patients with arthritis present in only one or two knee compartments. Partial knee arthroplasty can preserve the natural knee biomechanics, but these replacements may not last as long as total knee replacements. Robotic-assisted orthopedic techniques can help facilitate partial knee replacements, increasing accuracy and precision. This trial will investigate the feasibility and assess clinical outcomes for a larger definitive trial. METHODS: This is a protocol for an ongoing parallel randomized pilot trial of 64 patients with uni- or bicompartmental knee arthritis. Patients are randomized to either receive robot-assisted partial knee arthroplasty or manual total knee arthroplasty. The primary outcome of this pilot is investigating the feasibility of a larger trial. Secondary (clinical) outcomes include joint awareness, return to activities, knee function, patient global impression of change, persistent post-surgical pain, re-operations, resource utilization and cost-effectiveness, health-related quality of life, radiographic alignment, knee kinematics during walking gait, and complications up to 24 months post-surgery. DISCUSSION: The RoboKnees pilot study is the first step in determining the outcome of robot-assisted partial knee replacements. Conclusions from this study will be used to design future large-scale trials. This study will inform surgeons about the potential benefits of robot-assisted partial knee replacements. TRIAL REGISTRATION: This study was prospectively registered on clinicaltrials.gov (identifier: NCT04378049) on 4 May 2020, before the first patient was randomized.

Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): a protocol for a feasibility randomised controlled trial in patients undergoing total knee arthroplasty.

BACKGROUND: Knee arthritis is a leading cause of limited function and long-term disability in older adults. Despite a technically successful total knee arthroplasty (TKA), around 20% of patients continue to have persisting pain with reduced function, and low quality of life. Many of them continue using opioids for pain control, which puts them at risk for potential long-term adverse effects such as dependence, overdose and risk of falls. Although persisting pain and opioid use after TKA have been recognised to be important issues, individual strategies to decrease their burden have limitations and multi-component interventions, despite their potential, have not been well studied. In this study, we propose a multi-component pathway including personalized pain management, facilitated by a pain management coordinator. The objectives of this pilot trial are to evaluate feasibility (recruitment, retention, and adherence), along with opioid-free pain control at 8 weeks after TKA. METHODS: This is a protocol for a multicentre pilot randomised controlled trial using a 2-arm parallel group design. Adult participants undergoing unilateral total knee arthroplasty will be considered for inclusion and randomised to control and intervention groups. Participants in the intervention group will receive support from a pain management coordinator who will facilitate a multicomponent pain management pathway including (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation, (3) personalized post-discharge analgesic prescriptions and (4) continued support for pain control and recovery up to 8 weeks post-op. Participants in the control group will undergo usual care. The primary outcomes of this pilot trial are to assess the feasibility of participant recruitment, retention, and adherence to the interventions, and key secondary outcomes are persisting pain and opioid use. DISCUSSION: The results of this trial will determine the feasibility of conducting a definitive trial for the implementation of a multicomponent pain pathway to improve pain control and reduce harms using a coordinated approach, while keeping an emphasis on patient centred care and shared decision making. TRIAL REGISTRATION: Prospectively registered in Clinicaltrials.gov (NCT04968132).

Surgical indications for treatment for femoroacetabular impingement with surgical hip dislocation.

PURPOSE: There is a lack of detailed information about the indications of surgical treatment for femoroacetabular impingement (FAI), particularly using open surgical dislocation. The purpose of this review was to systematically review the reported indications for surgical dislocation of the hip for FAI. METHODS: Two databases (MEDLINE and EMBASE) were screened for clinical studies involving the treatment for FAI with surgical hip dislocation. We conducted a full-text review and the references for each included paper were hand-searched for other eligible studies. Papers published until September 2011 were included in this review. Two individuals reviewed all identified studies independently, and any disagreement was resolved through consensus. RESULTS: Fifteen studies met the eligibility criteria, which included a total of 822 patients. We identified a lack of consensus for clinical and radiographic indications for surgical hip dislocation to treat FAI. The most common clinical indications reported were clinical symptoms such as hip pain in 10 papers (67 %), a positive impingement sign in 9 papers (60 %), painful/reduced range of motion in 9 papers (60 %), activity-related groin pain in 4 papers (27 %), and non-responsive to non-operative treatment in 4 papers (27 %). The most commonly reported radiographic indicators for surgical hip dislocation were a variety of impingement findings from radiographs in all 15 included papers (100 %), a combination of radiographs and MRA in 5 papers (33 %) or radiographs and MRI in 3 papers (20 %). CONCLUSIONS: These results showed that that there was an inconsistency between the clinical and radiographic indications for surgical hip dislocation as a treatment for femoroacetabular impingement. This review suggests that there is a need for the development of standardized clinical and radiological criteria that serve as guidelines for surgical treatment for FAI. LEVEL OF EVIDENCE: Systematic review, Level IV.

Is the treatment gap in knee osteoarthritis real? A qualitative study of surgeons' perceptions.

BACKGROUND: Knee osteoarthritis (OA) is a chronic condition characterized by loss of joint cartilage that leads to persistent pain, loss of function, and disability. It has been reported that a treatment gap exists in a subset of knee OA patients who are unresponsive to conservative treatment yet are unsuitable for or unwilling to undergo more invasive, irreversible, surgical procedures. METHODS: Ten orthopedic healthcare professionals participated in a focus group (n=5) and semistructured interviews (n=5). We explored their perceptions on the treatment gap in knee OA patients and their opinions of the KineSpring® Knee Implant System. RESULTS: Among the responses of orthopedic healthcare professionals, we identified seven themes: (1) Delaying operative treatment for knee OA patients is very important. (2) Unrealistic expectations of younger patients play an important role in management of knee OA. (3) A treatment gap does exist. (4) Management of knee OA should be tailored to the individual patient. (5) The ability to delay total knee replacement without compromising the ability to do it in the future is important for the acceptance of the KineSpring System. (6) Improving patient lives by decreasing pain, improving function, and potentially delaying arthroplasty is important. (7) A well-designed randomized control trial and further evidence regarding the KineSpring System is desired. CONCLUSIONS: Orthopedic healthcare professionals are enthusiastic about the prospect of the KineSpring System as an option to help close the treatment gap in knee OA. Focusing only on clinical trials with long-term data may be impractical and deprive patients and society of benefits that can be gained while trial data are maturing.

Patient perspective survey of total hip vs total knee arthroplasty surgery.

A 42-item survey was developed and administered to determine patient perception of and satisfaction with total hip arthroplasty (THA) vs total knee arthroplasty (TKA). A total of 153 patients who had both primary THA and TKA for osteoarthritis with 1-year follow-up were identified. Survey response rate was 72%. Patients were more satisfied with THA meeting expectations for improvement in function and quality of life (P < .05), whereas pain relief expectations were equivalent. Most patients (70.9%) reported that TKA required more physiotherapy. One-year Oxford score and improvement in Oxford score from preoperative to 1 year were superior for THAs (P = .000). Despite equivalent pain relief, THAs trend toward higher satisfaction compared with TKAs. THA is more likely to "feel normal" with greater improvement in Oxford score. Recovery from TKA requires more physiotherapy and a longer time to achieve a satisfactory recovery status. Patients should be counseled accordingly.

Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): A feasibility randomized controlled trial in knee replacement patients.

Background: Total knee arthroplasties are the second most common surgery in Canada. Most patients recover well, but 20% or more still suffer from persistent pain and opioid use. Though opioids are an important part of perioperative pain management, their potential for long-term adverse effects is well recognized. Limiting opioids may be insufficient to overcome the issue of opioid overuse. Pain and opioid use are highly linked, so an effective alternative needs to address both issues. Objectives: The principal objective of this pilot trial is to assess the feasibility. The clinical objectives are to determine the effects of a multicomponent care pathway on opioid-free pain control, persisting pain and opioid use, functional knee outcomes, quality of life, and return to function. Methods: We will include adult patients scheduled for primary elective total knee arthroplasty. Patients in the intervention group will undergo a multicomponent intervention pathway that will be facilitated by an intervention coordinator linking each patient and their surgical/ perioperative team. The interventional pathway will include (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation using cognitive behavioral skills, (3) personalized postdischarge analgesic prescriptions, and (4) continued support for pain control and recovery up to 8 weeks. Patients in the control group will receive the usual care at their institution. Discussion: The overarching goal is to implement and evaluate a coordinated approach to clinical care to improve pain control and reduce harms, with an emphasis on patient-centered care and shared decision making.Trial Registration Number: NCT04968132 (informed consent/ research ethics board statement).

Contexte: L'arthroplastie totale du genou est la deuxième chirurgie la plus courante au Canada. La plupart des patients se rétablissent bien, mais au moins 20 pour cent d'entre eux souffrent encore de douleur persistante et de consommation d'opioïdes. Bien que les opioïdes soient un élément important de la prise en charge périopératoire de la douleur, leur potentiel d'effets indésirables à long terme est bien reconnu. La limitation des opioïdes peut être insuffisante pour surmonter le problème de la surconsommation d'opioïdes. La douleur et la consommation d'opioïdes sont étroitement liées, de sorte qu'une option de rechange efficace doit s'attaquer à ces deux problèmes.Objectifs: L'objectif principal de cet essai pilote est d'évaluer la faisabilité. Les objectifs cliniques sont de déterminer les effets d'une voie de soins à composantes multiples sur la maitrise de la douleur sans opioïdes, la douleur persistante et la consommation d'opioïdes, les résultats fonctionnels du genou, la qualité de vie et le retour à la fonction.Méthodes: Nous inclurons les patients adultes devant subir une arthroplastie primaire totale élective du genou. Les patients du groupe d'intervention seront soumis à une voie d'intervention à composantes multiples qui sera facilitée par un coordonnateur d'intervention reliant chaque patient et son équipe chirurgicale/périopératoire. La voie d'intervention comprendra (1) une éducation préopératoire sur la douleur et la consommation d'opioïdes, (2) la détermination et l'atténuation des risques préopératoires à l'aide de compétences comportementales cognitives, (3) des prescriptions analgésiques personnalisées après la sortie, et (4) un soutien continu pour la maîtrise de la douleur et la récupération pendant une période allant jusqu'à huit semaines. Les patients du groupe témoin recevront les soins habituels à leur établissement.Discussion: L'objectif global est de mettre en œuvre et d'évaluer une approche coordonnée des soins cliniques afin d'améliorer la maitrise de la douleur et réduire les méfaits, en mettant l'accent sur les soins centrés sur le patient et la prise de décision partagée. Numéro d'enregistrement de l'essai : NCT04968132 (consentement éclairé/déclaration du comité d'éthique de la recherche).

Quality of assessment of randomized controlled trials in blood conservation after joint arthroplasty.

Blood transfusion after joint arthroplasty occurs in up to two thirds of patients. We conducted a systematic review of the literature to determine the methodological quality of published randomized controlled trials (RCTs). We searched MEDLINE, EMBASE, and Cochrane to identify RCTs in arthroplasty with blood conservation as the primary outcome from 2001 to 2007. Methodological quality was evaluated using the Detsky index. We identified 62 RCTs. The mean Detsky score was 73% ± 14%. Epidemiology affiliation (P = .003), funding support (<.001), and year of publication (<.001) were the predictors of reporting quality, predicting 46% of the variability (R(2) = 0.46). This suggests poor reporting quality of trials in blood conservation. The inclusion of an epidemiologist or a biostatistician for the design of a trial is strongly recommended.

Unicompartmental Knee Arthroplasty: Survivorship and Risk Factors for Revision: A Population-Based Cohort Study with Minimum 10-Year Follow-up.

BACKGROUND: Operative management for end-stage knee osteoarthritis (OA) primarily consists of arthroplasty. Total knee arthroplasty (TKA) is the so-called gold standard for multicompartmental OA. In selected patients, specifically those with unicompartmental OA and no definite contraindications, realignment osteotomies and unicompartmental knee arthroplasty (UKA) are viable options. UKA offers several advantages over TKA, including preservation of both cruciate ligaments, faster recovery, and less osseous resection. The purpose of this study was to determine the survivorship of UKAs and risk factors for all-cause revision surgery in patients with a minimum follow-up of 10 years in a large population-based database. METHODS: We performed a population-based cohort study using linked administrative databases in Ontario, Canada. We identified all UKAs performed from January 2002 through December 2006. All patients had a minimum 10-year follow-up. Demographic data and outcomes were summarized using descriptive statistics. We used a Cox proportional hazards model with the Fine and Gray method accounting for competing risks such as death to analyze the effect of surgical and patient factors on the risk of revision of UKA. RESULTS: A total of 4,385 patients were identified as having undergone primary UKA from 2002 through 2006 in Ontario. Of these patients, 779 underwent revision surgery, for a cumulative risk for all-cause revision of 16.5% at 10 years (95% confidence interval [CI]: 15.4% to 17.7%). Mechanical loosening was the reason for 83.4% of all revisions. Male sex, diabetes, an age younger than 50 years, and cementless implants were significant risk factors for revision surgery. Residence in a rural or urban setting, income quintile, discharge destination, and type of OA were not associated with the risk of revision. Survivorship at 1, 5, 10, and 15 years was 97.2%, 90.5%, 83.5%, and 81.9%, respectively. CONCLUSIONS: This study demonstrated a >80% long-term survivorship for UKA based on a large administrative database sample and identified important risk factors for failure including male sex, younger age, diabetes, and cementless fixation. This study found rates of survivorship similar to those previously reported in the literature, while identifying key risk factors for failure. Patient selection has always been identified as a key factor in ensuring successful UKA, and the risk factors identified in this study may help guide decision-making for surgeons and patients dealing with unicompartmental knee OA. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Differential characteristics and management of pseudoseptic arthritis following hyaluronic acid injection is a rare complication: a systematic review.

IMPORTANCE: Acute pseudoseptic arthritis is a rare complication of hyaluronic acid (HA) injections that is not well documented in the literature. Practitioners initially suspect the symptoms of this complication to represent septic arthritis, cautiously prescribing antibiotics. This review identifies that time to presentation of symptoms postinjection, negative cell cultures and lack of crystallisation could be used as differentials to suspect pseudoseptic arthritis and to prescribe anti-inflammatory drugs while closely monitoring change of symptoms. OBJECTIVE: The purpose of this study was to describe the presentation, diagnosis and treatment of pseudoseptic arthritis. EVIDENCE REVIEW: A systematic review of the literature was conducted for studies reporting the use of HA injections for osteoarthritis resulting in pseudoseptic arthritis using the electronic databases MEDLINE, Embase and PubMed. Pertinent data were abstracted from the search yield. A unique case of a pseudoseptic reaction is also presented. FINDINGS: A total of 11 studies (28 cases), all of level IV and V evidence were included in this review. Reported cases of pseudoseptic arthritis in the literature present with severe joint pain (100%), effusion (100%), inability to weight-bear, functional impairment, and occasionally fever (22.2%). C reactive protein and erythrocyte sedimentation rate are generally elevated (71.4% and 85.7%, respectively), and leucocytosis above 10 000 was less common (50%). All reported cases in the literature identified aseptic growth on arthrocentesis, despite four cases (15.4%) reporting synovial leucocyte counts above 50 000. The presented case is the highest reported leucocyte count at 1 74 960 cells/mm3. CONCLUSIONS AND RELEVANCE: Acute pseudoseptic arthritis is rare, but a number of cases have been reported in the literature. A high degree of suspicion for pseudoseptic arthritis may be maintained in patients who present under 72 hours following HA injection. Initial antibiotic treatment, along with anti-inflammatory medications until cultures are confirmed to be negative at 5 days, is a cautious approach. However, the strength of this conclusion is limited by the few reported cases. Ultimately, this review is intended to inform practitioners of the symptoms, diagnosis and treatment of this complication, such that it could be safely differentiated from septic arthritis. LEVEL OF EVIDENCE: IV.

Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial.

BACKGROUND: After nonelective (i.e., semiurgent, urgent and emergent) surgeries, patients discharged from hospitals are at risk of readmissions, emergency department visits or death. During the coronavirus disease 2019 (COVID-19) pandemic, we are undertaking the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) trial to determine if virtual care with remote automated monitoring (RAM) compared with standard care will increase the number of days adult patients remain alive at home after being discharged following nonelective surgery. METHODS: We are conducting a randomized controlled trial in which 900 adults who are being discharged after nonelective surgery from 8 Canadian hospitals are randomly assigned to receive virtual care with RAM or standard care. Outcome adjudicators are masked to group allocations. Patients in the experimental group learn how to use the study's tablet computer and RAM technology, which will measure their vital signs. For 30 days, patients take daily biophysical measurements and complete a recovery survey. Patients interact with nurses via the cellular modem-enabled tablet, who escalate care to preassigned and available physicians if RAM measurements exceed predetermined thresholds, patients report symptoms, a medication error is identified or the nurses have concerns they cannot resolve. The primary outcome is number of days alive at home during the 30 days after randomization. INTERPRETATION: This trial will inform management of patients after discharge following surgery in the COVID-19 pandemic and offer insights for management of patients who undergo nonelective surgery in a nonpandemic setting. Knowledge dissemination will be supported through an online multimedia resource centre, policy briefs, presentations, peer-reviewed journal publications and media engagement. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT04344665.

Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial.

OBJECTIVE: To determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic. DESIGN: Multicentre randomised controlled trial. SETTING: 8 acute care hospitals in Canada. PARTICIPANTS: 905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up. INTERVENTION: Participants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre's usual care. Patients, healthcare providers, and data collectors were aware of patients' group allocations. Outcome adjudicators were blinded to group allocation. MAIN OUTCOME MEASURES: The primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation. RESULTS: All 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval -0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (-0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation. CONCLUSION: Virtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04344665.

Randomized controlled trials of surgical interventions.

BACKGROUND AND OBJECTIVES: Surgical trials pose many methodological challenges often not present in trials of medical interventions. If not properly accounted for, these challenges may introduce significant biases and threaten the validity of the results. METHODS: We systematically reviewed the significance of randomized controlled trials in the evaluation of surgical interventions, discussed the methodological challenges encountered in designing and conducting randomized controlled trials of surgical treatments, and proposed possible solutions to overcome these challenges. CONCLUSIONS: Many barriers and issues of surgical trials affecting internal validity can be overcome with proper methodology, and in most cases these issues do not restrict their conduct. Researchers should consider their research question carefully and design a surgical trial that contains features appropriate for the question. In doing so, they must ensure that the trial is valid, feasible, and affordable--a difficult feat, but one well worth the challenge.