Elective surgery in ankle and foot disorders-best practices for management of pain: a guideline for clinicians.

PURPOSE: Complex elective foot and ankle surgeries are often associated with severe pain pre- and postoperatively. When inadequately managed, chronic postsurgical pain and long-term opioid use can result. As no standards currently exist, we aimed to develop best practice pain management guidelines. METHODS: A local steering committee (n = 16) surveyed 116 North American foot and ankle surgeons to understand the "current state" of practice. A multidisciplinary expert panel (n = 35) was then formed consisting of orthopedic surgeons, anesthesiologists, chronic pain physicians, primary care physicians, pharmacists, registered nurses, physiotherapists, and clinical psychologists. Each expert provided up to three pain management recommendations for each of the presurgery, intraoperative, inpatient postoperative, and postdischarge periods. These preliminary recommendations were reduced, refined, and sent to the expert panel and "current state" survey respondents to create a consensus document using a Delphi process conducted from September to December 2020. RESULTS: One thousand four hundred and five preliminary statements were summarized into 51 statements. Strong consensus (≥ 80% respondent agreement) was achieved in 53% of statements including the following: postsurgical opioid use risk should be assessed preoperatively; opioid-naïve patients should not start opioids preoperatively unless non-opioid multimodal analgesia fails; and if opioids are prescribed at discharge, patients should receive education regarding importance of tapering opioid use. There was no consensus regarding opioid weaning preoperatively. CONCLUSIONS: Using multidisciplinary experts and a Delphi process, strong consensus was achieved in many areas, showing considerable agreement despite limited evidence for standardized pain management in patients undergoing complex elective foot and ankle surgery. No consensus on important issues related to opioid prescribing and cessation highlights the need for research to determine best practice.

RéSUMé: OBJECTIF: Les chirurgies électives complexes du pied et de la cheville sont souvent associées à une douleur intense avant et après l'opération. Lorsque cette douleur est mal prise en charge, elle peut entraîner une douleur postopératoire chronique et une consommation d'opioïdes à long terme. Comme il n'existe actuellement aucune norme, nous avons cherché à élaborer des lignes directrices sur les meilleures pratiques en matière de prise en charge de la douleur. MéTHODE: Un comité directeur local (n = 16) a interrogé 116 chirurgiens nord-américains spécialistes du pied et de la cheville pour comprendre « l'état actuel ¼ de la pratique. Un groupe d'experts multidisciplinaire (n = 35) a ensuite été formé, composé de chirurgiens orthopédistes, d'anesthésiologistes, de médecins spécialistes de la douleur chronique, de médecins de soins primaires, de pharmaciens, d'infirmières autorisées, de physiothérapeutes et de psychologues cliniciens. Chaque expert a fourni jusqu'à trois recommandations de prise en charge de la douleur pour chacune des périodes suivantes : en préchirurgie, en peropératoire, pendant l'hospitalisation postopératoire et après le congé. Ces recommandations préliminaires ont été réduites, affinées et envoyées au groupe d'experts et aux répondants du sondage sur « l'état actuel ¼ afin de créer un document de consensus à l'aide d'une méthode de Delphi réalisée entre septembre et décembre 2020. RéSULTATS: Mille quatre cent cinq déclarations préliminaires ont été résumées en 51 énoncés. Un consensus fort (≥ 80 % des répondants étaient d'accord) a été atteint concernant 53 % des énoncés, notamment les suivants : le risque de consommation postopératoire d'opioïdes devrait être évalué avant l'opération; les patients naïfs aux opioïdes ne devraient pas commencer à prendre des opioïdes avant l'opération, à moins que l'analgésie multimodale non opioïde n'échoue; et si des opioïdes sont prescrits au congé, les patients devraient être informés de l'importance de réduire leur consommation d'opioïdes. Il n'y avait pas de consensus concernant le sevrage des opioïdes en période préopératoire. CONCLUSION: À l'aide d'experts multidisciplinaires et d'une méthode de Delphi, un fort consensus a été atteint dans de nombreux aspects, montrant un accord considérable malgré des données probantes limitées pour une prise en charge standardisée de la douleur chez les patients subissant une chirurgie élective complexe du pied et de la cheville. L'absence de consensus sur des questions importantes liées à la prescription et à l'interruption des opioïdes souligne la nécessité de recherches pour déterminer les pratiques exemplaires.

Opioid prescribing practices prior to elective foot and ankle surgery: a population-based evaluation using health administrative data from a tertiary hospital in Canada.

BACKGROUND: Complex elective foot and ankle surgery is known to be painful so most patients are prescribed opioids at the time of surgery; however, the number of patients prescribed opioids while waiting for surgery in Canada is unknown. Our primary objective was to describe the pre and postoperative prescribing practices for patients in Alberta, Canada undergoing complex elective foot and ankle surgery. Secondarily, we evaluated postoperative opioid usage and hospital outcomes. METHODS: In this population-based retrospective analysis, we identified all adult patients who underwent unilateral elective orthopedic foot and ankle surgery at a single tertiary hospital between May 1, 2015 and May 31, 2017. Patient and surgical data were extracted from a retrospective chart review and merged with prospectively collected, individual level drug dispensing administrative data to analyze opioid dispensing patterns, including dose, duration, and prescriber for six months before and after foot and ankle surgery. RESULTS: Of the 100 patients, 45 had at least one opioid prescription dispensed within six months before surgery, and of these, 19 were long-term opioid users (> 90 days of continuous use). Most opioid users obtained opioid prescriptions from family physicians both before (78%) and after (65%) surgery. No preoperative non-users transitioned to long-term opioid use postoperatively, but 68.4% of the preoperative long-term opioid users remained long-term opioid users postoperatively. During the index hospitalization, preoperative long-term opioid users consumed higher doses of opioids (99.7 ± 120.5 mg/day) compared to opioid naive patients (28.5 ± 36.1 mg/day) (p < 0.001). Long-term opioid users stayed one day longer in hospital than opioid-naive patients (3.9 ± 2.8 days vs 2.7 ± 1.1 days; p = 0.01). CONCLUSIONS: A significant number of patients were dispensed opioids before and after foot and ankle surgery with the majority of prescriptions coming from primary care practitioners. Patients who were prescribed long-term opioids preoperatively were more likely to continue to use opioids at follow-up and required larger in-hospital opioid dosages and stayed longer in hospital. Further research and education for both patients and providers are needed to reduce the community-based prescribing of opioid medication pre-operatively and provide alternative pain management strategies prior to surgery to improve postoperative outcomes and reduce long-term postoperative opioid use.

Recovery and Return to Activity 1 Year After Ankle Fracture Managed With Open Reduction and Internal Fixation: A Prospective Longitudinal Cohort Study.

Background: Ankle fractures are common and frequently managed with open reduction and internal fixation (ORIF). Although these fractures can occur at any age, they are most common in younger individuals with high-energy trauma or older adults with lower-energy trauma. Our investigation focused on those aged 65 years or younger. Our primary objective was to describe recovery over the first postfracture year in (1) functional dorsiflexion using the weightbearing lunge test (WBLT), (2) patient-reported functional outcomes using the Olerud Molander Ankle Score (OMAS), (3) return to prefracture activity levels, and (4) return to work. Secondarily, we examined patient and clinical factors (including the WBLT and OMAS) associated with return to prefracture activities, including sports. Methods: Using a prospective inception cohort of 142 patients between 18 and 65 years old who underwent ORIF after ankle fracture and attended follow-up visits, we collected information from participants and their medical charts. We assessed functional dorsiflexion (using side-to-side difference in WBLT), patient-reported functional outcome (OMAS), and self-reported return to prefracture activity levels and work at 6 weeks, 6 months and 1 year postoperatively. Results: The WBLT, OMAS, and return to prefracture activity and work improved significantly over time (P < .001). However, at 1 year postoperation, the mean side-to-side difference in the WBLT was 3.22±2.68 cm, 69 (72%) reported ankle stiffness, and only 49 (52%) had returned to prefracture activity levels. Of those who were working, 97% had returned to work by 1 year postoperation. Only the OMAS (P < .001) and side-to-side difference in WBLT (P = .011) were significantly associated with return to prefracture activity levels. Conclusion: Although participants improved significantly over the first postoperative year in all outcomes, many reported limitations in functional dorsiflexion and return to prefracture activities. Those with higher OMAS scores and smaller side-to-side difference in WBLT were more likely to return to prefracture activity levels by 1 year postoperatively.Level of Evidence: Level II, prognostic study.

Perioperative pain management and chronic postsurgical pain after elective foot and ankle surgery: a scoping review.

PURPOSE: Chronic postsurgical pain (CPSP) can occur after elective mid/hindfoot and ankle surgery. Effective treatment approaches to prevent the development of CPSP in this population have not been extensively investigated. The impact of multimodal strategies to prevent CPSP following elective mid/hindfoot surgery is unknown because of both the heterogeneity of acute pain management and the lack of a recognized definition particular to this surgery. This review aimed to identify and evaluate current pain management strategies after elective mid/hindfoot and ankle surgery. SOURCES: Manual and electronic searches (MEDLINE, Embase, and Cochrane Library) were conducted of literature published between 1990 and July 2017. Comparative studies of adults undergoing elective mid/hindfoot and ankle surgery were included. Two reviewers independently reviewed studies and assessed their methodological quality. PRINCIPAL FINDINGS: We found seven randomized-controlled trials meeting our inclusion criteria. Interventions focused on regional anesthesia techniques such as continuous popliteal sciatic and femoral nerve blockade. Participants were typically followed up to 48 hr postoperatively. Only one study assessed pain six months following elective mid/hindfoot and ankle surgery. CONCLUSION: There is an overwhelming lack of evidence regarding CPSP and its management for patients undergoing elective mid/hindfoot and ankle surgery. The lack of a recognized and standard definition of CPSP after this group of surgeries precludes accurate and consistent evaluation.

RéSUMé: OBJECTIF: La douleur chronique post-chirurgicale (DCPC) peut survenir après une chirurgie non urgente de la section moyenne ou postérieure du pied, ou de la cheville. Les approches thérapeutiques efficaces pour prévenir l'apparition de DCPC dans cette population n'ont pas été examinées en profondeur. L'impact des stratégies multimodales pour prévenir la DCPC après une chirurgie non urgente de la section moyenne ou postérieure du pied est inconnu, tant en raison de l'hétérogénéité de la prise en charge de la douleur aiguë que du manque de définition reconnue spécifique à ce type de chirurgie. Ce compte-rendu a pour objectif d'identifier et d'évaluer les stratégies de prise en charge de la douleur actuellement utilisées après une chirurgie de la section moyenne ou postérieure du pied, ou de la cheville. SOURCES: Des recherches manuelles et électroniques (MEDLINE, Embase, et Librairie Cochrane) ont été menées dans la littérature publiée entre 1990 et juillet 2017. Les études comparatives portant sur des adultes subissant une chirurgie non urgente de la section moyenne ou postérieure du pied ou de la cheville ont été incluses. Deux chercheurs ont indépendamment passé en revue les études et évalué leur qualité méthodologique. CONSTATATIONS PRINCIPALES: Nous avons trouvé sept études randomisées contrôlées respectant nos critères d'inclusion. Les interventions se concentraient sur des techniques d'anesthésie régionale tels que les blocs continus des nerfs sciatiques poplités et fémoraux. Les participants bénéficiaient en général d'un suivi jusqu'à 48 h après l'opération. Une seule étude a évalué la douleur six mois après une chirurgie non urgente de la section moyenne ou postérieure du pied ou de la cheville. CONCLUSION: L'absence de données probantes est colossale en ce qui touche à la DCPC et à sa prise en charge pour les patients subissant une chirurgie non urgente de la partie moyenne ou postérieure et de la cheville. L'absence de définition normalisée et reconnue de la DCPC après ce type de chirurgie en exclut toute évaluation précise et cohérente.

Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus.

BACKGROUND:: A prospective, randomized, noninferiority clinical trial of synthetic cartilage implant hemiarthroplasty for hallux rigidus demonstrated functional outcomes and safety equivalent to first metatarsophalangeal (MTP) joint arthrodesis at 24 months. We prospectively assessed safety and efficacy outcomes for synthetic cartilage implant hemiarthroplasty at a minimum of 5 years. METHODS:: Of 135 eligible patients from the original trial, 112 (83.0%) were enrolled (mean age, 58.2 ± 8.8 years; 87 females). Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL), and FAAM Sports subscales were completed preoperatively and 2 and 5 years postoperatively. Great toe active dorsiflexion, weightbearing radiographs, secondary procedures, and safety parameters were also evaluated. RESULTS:: At 24 months, 14/152 (9.2%) patients had undergone implant removal and conversion to arthrodesis. In years 2 to 5, 9/119 (7.6%) patients underwent implant removal and conversion to arthrodesis. At mean 5.8 ± 0.7 (range, 4.4-8.0) years' follow-up, pain VAS, FAAM ADL, and FAAM Sports scores improved by 57.9 ± 18.6 points, 33.0 ± 17.6 points, and 47.9 ± 27.1 points, respectively, from baseline. Clinically significant changes in VAS pain, FAAM ADL, and FAAM Sports were reported by 103/106 (97.2%), 95/105 (90.5%), and 97/104 (93.3%) patients, respectively. Patient-reported outcomes at 24 months were maintained at 5.8 years in patients who were not revised. Active MTP joint peak dorsiflexion was maintained. Ninety-nine of 106 (93.4%) patients would have the procedure again. CONCLUSION:: Clinical and safety outcomes for synthetic cartilage implant hemiarthroplasty observed at 2 years were maintained at 5.8 years. The implant remains a viable treatment option to decrease pain, improve function, and maintain motion for advanced hallux rigidus. LEVEL OF EVIDENCE:: Level IV, case series.

Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: A comparison of operative and recovery time.

BACKGROUND: First metatarsophalangeal joint (MTPJ1) hemiarthroplasty using a novel synthetic cartilage implant was as effective and safe as MTPJ1 arthrodesis in a randomized clinical trial. We retrospectively evaluated operative time and recovery period for implant hemiarthroplasty (n=152) and MTPJ1 arthrodesis (n=50). METHODS: Perioperative data were assessed for operative and anaesthesia times. Recovery and return to function were prospectively assessed with the Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) subscales and SF-36 Physical Functioning (PF) subscore. RESULTS: Mean operative time for hemiarthroplasty was 35±12.3min and 58±21.5min for arthrodesis (p<0.001). Anaesthesia duration was 28min shorter with hemiarthroplasty (p<0.001). At weeks 2 and 6 postoperative, hemiarthroplasty patients demonstrated clinically and statistically significantly higher FAAM Sport, FAAM ADL, and SF-36 PF subscores versus arthrodesis patients. CONCLUSION: MTPJ1 hemiarthroplasty with a synthetic cartilage implant took less operative time and resulted in faster recovery than arthrodesis. LEVEL OF EVIDENCE: III, Retrospective case control study.

Correlation of Hallux Rigidus Grade With Motion, VAS Pain, Intraoperative Cartilage Loss, and Treatment Success for First MTP Joint Arthrodesis and Synthetic Cartilage Implant.

BACKGROUND: Grading systems are used to assess severity of any condition and as an aid in guiding treatment. This study examined the relationship of baseline motion, pain, and observed intraoperative cartilage loss with hallux rigidus grade. METHODS: A prospective, randomized study examining outcomes of arthrodesis compared to synthetic cartilage implant was performed. Patients underwent preoperative clinical examination, radiographic assessment, hallux rigidus grade assignment, and intraoperative assessment of cartilage loss. Visual analog scale (VAS) score for pain was obtained preoperatively and at 24 months. Correlation was made between active peak dorsiflexion, VAS pain, cartilage loss, and hallux rigidus grade. Fisher's exact test was used to assess grade impact on clinical success ( P < .05). RESULTS: In 202 patients, 59 (29%), 110 (55%), and 33 (16%) were classified as Coughlin grades 2, 3, and 4, respectively. There was no correlation between grade and active peak dorsiflexion (-0.069, P = .327) or VAS pain (-0.078, P = .271). Rank correlations between grade and cartilage loss were significant, but correlations were small. When stratified by grade, composite success rates between the 2 treatments were nearly identical. CONCLUSIONS: Irrespective of the grade, positive outcomes were demonstrated for both fusion and synthetic cartilage implant. Clinical symptoms and signs should be used to guide treatment, rather than a grade consisting of radiographic, symptoms, and range of motion factors. LEVEL OF EVIDENCE: Level II, randomized clinical trial.

Association Between Patient Factors and Outcome of Synthetic Cartilage Implant Hemiarthroplasty vs First Metatarsophalangeal Joint Arthrodesis in Advanced Hallux Rigidus.

BACKGROUND: We evaluated data from a clinical trial of first metatarsophalangeal joint (MTPJ1) implant hemiarthroplasty and arthrodesis to determine the association between patient factors and clinical outcomes. METHODS: Patients ≥18 years with hallux rigidus grade 2, 3, or 4 were treated with synthetic cartilage implant MTPJ1 hemiarthroplasty or arthrodesis. Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) sports and activities of daily living (ADL) scores, and Short Form-36 Physical Function (SF-36 PF) subscore were obtained preoperatively, and at 2, 6, 12, 24, 52, and 104 weeks postoperatively. Final outcome data, great toe active dorsiflexion motion, secondary procedures, radiographs, and safety parameters were evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. The composite primary endpoint criteria for clinical success included VAS pain reduction ≥30%, maintenance/improvement in function, no radiographic complications, and no secondary surgical intervention at 24 months. Predictor variables included hallux rigidus grade; gender; age; body mass index (BMI); symptom duration; prior MTPJ1 surgery; preoperative hallux valgus angle, range of motion (ROM), and pain. Two-sided Fisher exact test was used ( P < .05). RESULTS: Patient demographics and baseline outcome measures were similar. Success rates between implant MTPJ1 hemiarthroplasty and arthrodesis were similar ( P > .05) when stratified by hallux rigidus grade, gender, age, BMI, symptom duration, prior MTPJ1 surgery status, and preoperative VAS pain, hallux valgus, and ROM. CONCLUSION: Synthetic cartilage implant hemiarthroplasty was appropriate for patients with grade 2, 3, or 4 hallux rigidus. Its results in those with associated mild hallux valgus (≤20 degrees) or substantial preoperative stiffness were equivalent to MTPJ1 fusion, irrespective of gender, age, BMI, hallux rigidus grade, preoperative pain or symptom duration. LEVEL OF EVIDENCE: Level II, randomized clinical trial.

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

BACKGROUND: Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. METHODS: In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were nonrandomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. RESULTS: VAS pain scores decreased significantly in both the implant and arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6.2 degrees (27.3%) after implant placement and was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2%) implant patients (17 procedures) and 6 (12.0%) arthrodesis patients (7 procedures). Fourteen (9.2%) implants were removed and converted to arthrodesis, and 6 (12.0%) arthrodesis patients (7 procedures [14%]) had isolated screws or plate and screw removal. There were no cases of implant fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical equivalence between the implant and arthrodesis groups. CONCLUSION: A prospective, randomized (2:1), controlled, noninferiority clinical trial was performed to compare the safety and efficacy of a small synthetic cartilage bone implant to first MTP arthrodesis in patients with advanced-stage hallux rigidus. This study showed equivalent pain relief and functional outcomes. The synthetic implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP motion. The percentage of secondary surgical procedures was similar between groups. Less than 10% of the implant group required revision to arthrodesis at 2 years. LEVEL OF EVIDENCE: Level I, prospective randomized study.

The Development and validation of a self-administered quality-of-life outcome measure for young, active patients with symptomatic hip disease: the International Hip Outcome Tool (iHOT-33).

PURPOSE: The purpose of this study was to develop a self-administered evaluative tool to measure health-related quality of life in young, active patients with hip disorders. METHODS: This outcome measure was developed for active patients (aged 18 to 60 years, Tegner activity level ≥ 4) presenting with a variety of symptomatic hip conditions. This multicenter study recruited patients from international hip arthroscopy and arthroplasty surgeon practices. The outcome was created using a process of item generation (51 patients), item reduction (150 patients), and pretesting (31 patients). The questionnaire was tested for test-retest reliability (123 patients); face, content, and construct validity (51 patients); and responsiveness over a 6-month period in post-arthroscopy patients (27 patients). RESULTS: Initially, 146 items were identified. This number was reduced to 60 through item reduction, and the items were categorized into 4 domains: (1) symptoms and functional limitations; (2) sports and recreational physical activities; (3) job-related concerns; and (4) social, emotional, and lifestyle concerns. The items were then formatted using a visual analog scale. Test-retest reliability showed Pearson correlations greater than 0.80 for 33 of the 60 questions. The intraclass correlation statistic was 0.78, and the Cronbach α was .99. Face validity and content validity were ensured during development, and construct validity was shown with a correlation of 0.81 to the Non-Arthritic Hip Score. Responsiveness was shown with a paired t test (P ≤ .01), effect size of 2.0, standardized response mean of 1.7, responsiveness ratio of 6.7, and minimal clinically important difference of 6 points. CONCLUSIONS: We have developed a new quality-of-life patient-reported outcome measure, the 33-item International Hip Outcome Tool (iHOT-33). This questionnaire uses a visual analog scale response format designed for computer self-administration by young, active patients with hip pathology. Its development has followed the most rigorous methodology involving a very large number of patients. The iHOT-33 has been shown to be reliable; shows face, content, and construct validity; and is highly responsive to clinical change. In our opinion the iHOT-33 can be used as a primary outcome measure for prospective patient evaluation and randomized clinical trials.