Comparing the Interobserver Reliability of 4 Methods Used to Measure Knee Laxity on Coronal Plane Stress Radiograph.

Background: Varus and valgus knee stress radiographs provide valuable information in the pre- and postoperative evaluation of joint laxity in patients with multiligament knee injuries (MLKIs). Purpose: To review the literature for described techniques of quantifying laxity on coronal stress radiographs of the knee and identify the most reliable method. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: A thorough literature search using the MEDLINE and Embase databases identified 4 studies with distinct methods for objectively measuring laxity on varus and valgus stress radiographs: Heesterbeek et al (2008), Jacobsen (1976), LaPrade et al (2004), and Sawant et al (2004). To compare these methods, 200 coronal plane stress radiographs from 50 patients with MLKIs were retrospectively reviewed from an MLKI database at a single institution. The amount of varus and valgus laxity on each radiograph was measured independently by 4 reviewers using each method. Intraclass correlation coefficients (ICCs) with 95% CIs were calculated to assess the interobserver reliability of each method overall and the varus and valgus measurements individually. Results: For all 4 methods, the overall interobserver reliability was considered at least moderate. The method by Heesterbeek et al proved to have the highest interrater reliability in all domains-overall (ICC, 0.87 [95% CI, 0.85-0.90]), valgus (ICC, 0.83 [95% CI, 0.78-0.88]), and varus (ICC, 0.87 [95% CI, 0.83-0.90])-demonstrating good to excellent reliability both overall and in varus measurements and showing good reliability in valgus measurements. The method by Sawant et al demonstrated good reliability in valgus measurements. All other measures demonstrated moderate reliability. Conclusion: Available methods for measuring knee joint laxity on varus and valgus knee stress radiographs in patients with MLKIs demonstrated moderate to good interobserver reliability. The method described by Heesterbeek et al proved to have the highest reliability overall as well as in measurements on varus and valgus views individually.

Metal hypersensitivity in foot & ankle orthopaedic surgery: A systematic review.

Introduction: Metal hypersensitivity affects 10-15% of individuals. Orthopaedic implants contain various metals and, therefore, metal hypersensitivity may impact patient outcomes. Purpose: We report a systematic review of the literature on metal hypersensitivity in patients undergoing foot and ankle (F&A) surgery. Our goal is to provide an overview presenting symptoms, diagnostic methods, treatment, and clinical outcomes. Methods: A comprehensive literature search of Ovid MEDLINE and EMBASE was performed from its inception (01-Jan 1966) to 23-Nov 2021. MeSH search terms on F&A were used including orthopaedic surgeries, metal types, and hypersensitivity. All full-text, English, experimental and observational studies reporting on metal hypersensitivity in the context of foot and/or ankle surgeries using metallic orthopaedic devices were included. Article screening, critical appraisal, and data extraction was performed by two reviewers. Disagreements were resolved by a third reviewer. Results: Fifteen studies were identified, reporting on 45 patients (18 male and 27 female). Median age was 58 years and mean follow-up was 20.8 months. 42 static and three arthroplasty implants were included. In total, 19 patients (42.2%) were diagnosed with metal hypersensitivity to a constituent of their implant, including two (4.4%) patients diagnosed without metal hypersensitivity testing. Twenty-six patients (57.8%) tested negative to their metal implant components. Of the 19 patients allergic to a constituent of their implant, 14 underwent hardware removal and improved. Four patients were asymptomatic and the last was symptomatic, but not revised. Of these, 23 patients retained their hardware (eight with skin reactions) and two symptomatic patients underwent hardware removal. Conclusion: Metal hypersensitivity in the context of F&A surgery is not widely reported. It should be a differential diagnosis in patients who present with hypersensitivity-type symptoms once infection and mechanical failure are ruled out. This data informs a comprehensive algorithm for identifying and treating metal hypersensitivity in F&A patients. Level of evidence: Level IV.

Kinesiophobia contributes to worse functional and patient-reported outcome measures in Achilles tendinopathy: a systematic review.

PURPOSE: To assess the effect of kinesiophobia or fear of reinjury on patient-reported outcome measures and physical performance measures in patients with chronic Achilles tendinopathy (AT). METHODS: Three databases were systematically screened for studies from inception to May 22nd, 2023 for literature investigating the impact of kinesiophobia on PROMs or physical performance metrics in AT. The authors adhered to the PRISMA and R-AMSTAR guidelines as well as the Cochrane Handbook for Systematic Reviews of Interventions. Data on demographics, pain, level of activity, self-reported injury severity, quality of life, single-leg hop performance, and heel-raise performance were recorded. Data was presented primarily in a narrative summary fashion. The MINORS score was used for all studies to perform a quality assessment of included studies. RESULTS: Six studies comprising 705 patients were included in this review. Variations of the Tampa Scale of Kinesiophobia (TSK-11 or TSK-17) were used in all studies. TSK scores were strongly correlated with the Pain Catastrophizing Score (PCS) and Visual Analogue Scale (VAS) scores and were correlated with decreased Victorian Institute of Sports Assessment Achilles (VISA-A) and Foot and Ankle Outcome Scores Quality of Life (FAOS-QoL) subscale scores. Kinesiophobia was associated with heel raise completion with conflicting evidence on correlations with hop test performance. CONCLUSION: Increased kinesiophobia scores (> 35 points), measured by TSK are associated with worse PROMs, including increased pain, decreased quality of life, increased self-reported severity, and is also associated with poorer physical performance measures in patients with AT. LEVEL OF EVIDENCE: IV.

Impact of COVID-19 pandemic on foot care services in Ontario, Canada.

BACKGROUND: The COVID-19 pandemic has directly affected the delivery of health care services in Canada, including foot care. The goal of this descriptive study was to understand the impact of the early COVID-19 pandemic (March 2020 to April 2021) on chiropodists' and podiatrists' clinical practices and foot care service delivery in Ontario, Canada. METHODS: A web-survey was completed by participating chiropodists and podiatrists registered with the College of Chiropodists of Ontario. The survey consisted of 31 multiple choice and open-ended items on clinical practice characteristics, foot care service delivery changes, perceived barriers during the pandemic, and its impact on clinicians. Descriptive statistics were used to characterize the sample and examine clinicians' responses, and qualitative content analysis was used to explore opened-ended items. RESULTS: Of the 773 eligible clinicians, 279 participated for a response rate of 36.1%. Most respondents reported a decline in patient volume, an increase in urgent foot health problems, a financial impact on their clinical practices, an emotional impact, and substantial changes to how they provided foot care services, such as incorporating telehealth/virtual care into patient care. Factors that impact clinicians' perception of future pandemic preparedness are identified. CONCLUSION: This study describes foot care service delivery in Ontario, Canada during the COVID-19 pandemic. The COVID-19 pandemic saw an increase in urgent foot health problems, decline in patient volume, and impacted clinicians' mental health and emotional well-being. Future studies should examine patients' experiences of foot care service delivery and maintaining their foot health during the pandemic, and further examination of factors that impact clinicians' perception of pandemic preparedness.

Sex Differences in End-Stage Ankle Arthritis and Following Total Ankle Replacement or Ankle Arthrodesis.

BACKGROUND: We investigated the influence of sex on patient-reported outcomes preoperatively and following total ankle replacement and ankle arthrodesis. METHODS: Patients who had undergone total ankle replacement or ankle arthrodesis for the treatment of end-stage ankle arthritis and who had ≥2 years of follow-up were identified from the Canadian Orthopaedic Foot and Ankle Society Prospective Ankle Reconstruction Database. Standard surgical techniques and implantation methods were followed, and STAR, Hintegra, Mobility, and Agility prostheses were used. Data were collected on patient demographics, revisions, secondary procedures, complications, Ankle Osteoarthritis Scale (AOS) scores, Short Form-36 (SF-36) scores, and expectations and satisfaction. Statistical analyses included 3-way repeated-measures analysis of variance (ANOVA) and multiple linear regression models controlling for inflammatory arthritis, age, preoperative scores, and surgery type. RESULTS: The study included 872 patients: 629 who had undergone total ankle replacement (316 men, 313 women) and 243 who had undergone ankle arthrodesis (154 men, 89 women). The mean duration of follow-up (and standard deviation) was 4.9 ± 2.4 and 4.0 ± 1.9 years for the total ankle replacement and ankle arthrodesis groups, respectively. Men were older than women (p ≤ 0.001). In both the total ankle replacement and ankle arthrodesis groups, women had higher AOS pain scores (i.e., more pain) than men preoperatively (p < 0.05). Pain was reduced significantly in both sexes postoperatively (p < 0.05), with no significant difference between sexes. In both the total ankle replacement and ankle arthrodesis groups, women had higher AOS disability scores (i.e., more disability) and lower SF-36 Physical Component Summary (PCS) scores (i.e., worse function) than men both preoperatively and postoperatively (p < 0.001). Postoperatively, AOS disability and SF-36 PCS scores improved significantly from baseline in both sexes (p < 0.001). After controlling for covariates, sex was not a significant predictor of postoperative SF-36 MCS (Mental Component Summary), AOS pain, or AOS disability scores (p > 0.05) but explained 0.5% of variance in SF-36 PCS scores (p = 0.03). Sex did not significantly influence preoperative expectations or postoperative satisfaction. When patients with inflammatory arthritis were excluded, preoperative and postoperative outcome measures, expectations, and satisfaction were similar. CONCLUSIONS: Men and women with end-stage ankle arthritis benefited from total ankle replacement and ankle arthrodesis with similar magnitudes of improvement. Small differences in pain and function between men and women undergoing total ankle replacement and ankle arthrodesis mostly disappeared when controlling for potential confounding variables. Both total ankle replacement and ankle arthrodesis remain good options for men and women with end-stage ankle arthritis. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Two-Year Outcomes After Total Ankle Replacement With a Novel Fixed-Bearing Implant.

BACKGROUND: The Integra Cadence total ankle replacement (TAR) is a fourth-generation anatomic, fixed-bearing implant requiring minimal tibial and talar resection, which has been in clinical use since June 2016. The primary purpose of this study is to assess its short-term clinical and radiographic outcomes after TAR using this prosthesis. METHODS: This is a prospective case series of consecutive patients that underwent TAR using this novel fourth-generation prosthesis between June 2016 and November 2017. The primary outcome of interest was the Ankle Osteoarthritis Scale (AOS). Secondary outcomes included Short Form Health Survey-36 (SF-36) scores, radiographic alignment, complications, reoperations, and revisions. RESULTS: In total, 69 patients were included in our study. Fifty-one patients (73.9%) required a total of 91 ancillary procedures. Postoperatively, AOS pain scores decreased significantly by an average of 17.8±30.1 points from 45.9±18.2 to 28.4±27.3 (P < .001). AOS disability scores also decreased significantly following surgery by an average of 22.0±30.5 points from 53.9±18.5 to 32.5±27.9 (P < .001). The SF-36 physical component summary score improved 10.4±9.8 points from 33.1±9.1 to 42.6±9.1 (P < .001). Radiographic analysis demonstrated significant improvement to neutral coronal plane alignment, which was achieved in 97% of patients (P < .01) with no cyst formation at 2 years. There was 1 reported complication, 9 reoperations, and no metal or polyethylene component revisions. Overall, the 2-year implant survivorship was 100% in our cohort. Eighteen patients (26.1%) demonstrated fibrous ingrowth of the tibial component. However, outcome scores for these patients did not demonstrate any negative effects. CONCLUSION: In our hands, this TAR system demonstrated excellent early clinical and radiographic outcomes. Patients reported improved physical health status, pain, and disability in the postoperative period. Total ankle instrumentation allowed for accurate and reproducible implantation with correction of coronal and sagittal plane deformities. Early results for the clinical use of this TAR system are promising, but further long-term prospective outcome studies are necessary. LEVEL OF EVIDENCE: Level IV, case series.

Living With Both a Total Ankle Replacement and an Ankle Fusion: A Qualitative Study From the Patients' Perspective.

BACKGROUND: Total ankle replacement (TAR) and ankle fusion are effective treatments for end-stage ankle arthritis. Comparative studies elucidate differences in treatment outcomes; however, the literature lacks evidence demonstrating what outcomes are important to patients. The purpose of this study was to investigate patients' experiences of living with both a TAR and ankle fusion. METHODS: This research study used qualitative description. Individuals were selected from a cohort of patients with TAR and/or ankle fusion (n = 1254). Eligible patients were English speaking with a TAR and contralateral ankle fusion, and a minimum of 1 year since their most recent ankle reconstruction. Surgeries were performed by a single experienced surgeon, and semistructured interviews were conducted by a single researcher in a private hospital setting or by telephone. Ankle Osteoarthritis Scale (AOS) scores, radiographs, and ancillary surgical procedures were collected to characterize patients. Themes were derived through qualitative data analysis. RESULTS: Ten adults (8 men, 2 women), ages 59 to 90 years, were included. Average AOS pain and disability scores were similar for both surgeries for most patients. Participants discussed perceptions of each reconstructed ankle. Ankle fusions were considered stable and strong, but also stiff and compromising balance. TARs were considered flexible and more like a "normal ankle," though patients expressed concerns about their TAR "turning" on uneven ground. Individuals applied this knowledge to facilitate movement, particularly during a first step and transitioning between positions. They described the need for careful foot placement and attention to the environment to avoid potential challenges. CONCLUSION: This study provides insight into the experiences of individuals living with a TAR and ankle fusion. In this unusual but limited group of patients, we found that each ankle reconstruction was generally perceived to have different characteristics, advantages, and disadvantages. Most participants articulated a preference for their TAR. These findings can help clinicians better counsel patients on expectations after TAR and ankle fusion, and improve patient-reported outcome measures by better capturing meaningful outcomes for patients. LEVEL OF EVIDENCE: Level IV, case series.

Should 15° of valgus coronal-plane deformity be the upper limit for a total ankle arthroplasty?

AIMS: Preoperative talar valgus deformity ≥ 15° is considered a contraindication for total ankle arthroplasty (TAA). We compared operative procedures and clinical outcomes of TAA in patients with talar valgus deformity ≥ 15° and < 15°. METHODS: A matched cohort of patients similar for demographics and components used but differing in preoperative coronal-plane tibiotalar valgus deformity ≥ 15° (valgus, n = 50; 52% male, mean age 65.8 years (SD 10.3), mean body mass index (BMI) 29.4 (SD 5.2)) or < 15° (control, n = 50; 58% male, mean age 65.6 years (SD 9.8), mean BMI 28.7 (SD 4.2)), underwent TAA by one surgeon. Preoperative and postoperative radiographs, Ankle Osteoarthritis Scale (AOS) pain and disability and 36-item Short Form Health Survey (SF-36) version 2 scores were collected prospectively. Ancillary procedures, secondary procedures, and complications were recorded. RESULTS: At mean 5.1 years follow-up (SD 2.6) (valgus) and 6.6 years (SD 3.3) (controls), mean AOS scores decreased and SF-36 scores increased significantly in both groups. Improvements in scores were similar for both groups - AOS pain: valgus, mean 26.2 points (SD 24.2), controls, mean 22.3 points (SD 26.4); AOS disability: valgus, mean 41.2 points (SD 25.6); controls, mean 34.6 points (SD 24.3); and SF-36 PCS: valgus, mean 9.1 points (SD 14.1), controls, mean 7.4 points (SD 9.8). Valgus ankles underwent more ancillary procedures during TAA (40 (80%) vs 13 (26%)) and more secondary procedures postoperatively (18 (36%) vs 7 (14%)) than controls. Tibiotalar deformity improved significantly (p < 0.001) towards a normal weightbearing axis in valgus ankles. Three valgus and four control ankles required subsequent fusion, including two for deep infections (one in each group). CONCLUSION: Satisfactory mid-term results were achieved in patients with preoperative valgus malalignment ≥ 15°, but they required more adjunctive procedures during and after TAA. Valgus coronal-plane deformity ≥ 15° is not an absolute contraindication for TAA if associated deformities are addressed. Cite this article: Bone Joint J 2020;102-B(12):1689-1696.

Effect of Novel Anteromedial Approach on Wound Complications Following Ankle Arthroplasty.

BACKGROUND: The purpose of this study was to evaluate all wound complications following total ankle arthroplasty (TAA) before and after the implementation of a novel extensile anteromedial surgical approach. We further investigated patients and operative factors associated with wound complications. METHODS: A series of 660 TAAs were collected. The median follow-up was 84 months (range, 12-204 months). Minor wound complications included discoloration, swelling, or clinical concern that merited bringing the patient back sooner for review. Major wound complications included plastic surgical consultation, debridement by the nurse specialist, negative pressure therapy, or reoperation. All major complications initially had a course of empirical oral antibiotics. Since 2011, higher-risk patients have had their TAA performed through an extensile anteromedial approach. RESULTS: Fifty-six patients (8.5%) had wound healing issues (17 major [2.6%], 39 minor [5.9%]). All issues became evident <21 days postoperatively. Inflammatory arthritis, smoking, and coronary disease were patient factors associated with major wound complications. Four patients were treated with negative pressure therapy, 4 with debridement in the operating room, and 2 eventually converted to fusions. Fourteen patients (82%) who had major complications had an ancillary procedure to balance the TAA through a separate incision. All major wound complications had an anterior surgical approach for their TAA. Before 2011, there were 13 major wound complications. Since 2012, there have been 4 major wound complications overall, with no wound complications in the anteromedial approach cohort. CONCLUSION: We recommend an extensile anteromedial approach for smokers and patients with heart disease or inflammatory arthritis undergoing TAA. If a wound complication developed, a multidisciplinary team to evaluate wounds was useful. LEVEL OF EVIDENCE: Level III, retrospective comparative series.

"I Don't Have to Think About Watching the Ground": A Qualitative Study Exploring the Concept of Vigilance as an Important Outcome for Ankle Reconstruction.

OBJECTIVE: To understand patients' experiences of ankle reconstruction for treatment of end-stage ankle osteoarthritis. METHODS: Individuals were recruited from a cohort of individuals who had undergone total ankle replacement or ankle fusion. English-speaking individuals who had surgery at least 1 year prior were invited to participate. Semistructured, face-to-face interviews relying on a phenomenological approach were conducted in a private hospital clinic room. RESULTS: A total of 25 adults (12 women, 13 men), ages 25-82 years, were interviewed for 1-2 hours. Participants commonly described a state of having to keep careful watch for potential environmental challenges. Vigilance was related to ongoing symptoms (i.e., pain, stiffness) and concerns regarding balance, stability, and potential damage to the fused ankle or implant. Vigilance was described along a continuum, with higher levels associated with stress and mental exhaustion. Vigilance affected participants' perception of their surgical outcome, with high vigilance levels linked to negative perceptions of outcome. The degree to which individuals perceived the need for vigilance was influenced by environmental factors like uneven ground or crowds. Contrary to descriptions of vigilance in the coping literature, vigilance related to ankle reconstruction constituted a situational, rather than dispositional, response. CONCLUSION: Vigilance and its associated burden are not captured by current instruments. The mental load and worry associated with vigilance was important to patients, distinct from related pain or functional status. Thus, reducing high levels of vigilance appears to be an appropriate target for patient-centered treatment outcomes. A thorough battery of outcome measures for ankle reconstruction should consider this domain.

Recombinant Human Platelet-Derived Growth Factor BB in Combination With a Beta-Tricalcium Phosphate (rhPDGF-BB/ß-TCP)-Collagen Matrix as an Alternative to Autograft.

BACKGROUND: Joint arthrodesis often employs autograft to promote union; graft harvesting can lead to perioperative morbidity. A Canadian randomized controlled trial (RCT) demonstrated that recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) combined with beta-tricalcium phosphate (ß-TCP)-collagen was a safe, effective alternative to autograft. This multicenter North American RCT compared the safety and efficacy of rhPDGF-BB/ß-TCP-collagen with autograft for ankle and hindfoot fusion. Subclassification using propensity scores (PS) incorporated patients from previous trials for enhanced statistical power for noninferiority testing and broader review of treatments. METHODS: Patients requiring ankle or hindfoot arthrodesis and supplemental bone graft were treated with rhPDGF-BB/ß-TCP-collagen (n = 69) or autograft (n = 35). Outcomes included joint fusion on computed tomography (24 weeks), clinical healing status, visual analog scale (VAS) pain, Short-Form 12 (SF-12), American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Scale, and Foot Function Index (FFI) scores over 52 weeks. PS methodology addressed potential selection bias arising from pooling data among these patients and 2 previous RCTs with similar inclusion criteria, surgical techniques, graft harvest techniques, and outcomes. All 132 rhPDGF-BB/ß-TCP-collagen-treated patients and 167 of 189 candidate autograft-treated controls were selected for comparison by an independent statistician blinded to outcomes. RESULTS: In the PS subclassification, 68.1% treatment patients and 68.4% controls achieved >50% osseous bridging at fusion sites. Clinical healing status was achieved in 84.8% of treated patients and 90.7% of controls at 52 weeks. Clinical, functional, and quality of life results demonstrated noninferiority of rhPDGF-BB/ß-TCP-collagen to autograft. Safety-related outcomes were equivalent. CONCLUSION: PS subclassification analysis of 3 RCTs demonstrated that rhPDGF-BB/ß-TCP-collagen was as effective as autograft for ankle and hindfoot fusions, with less pain and morbidity than treatment with autograft. LEVEL OF EVIDENCE: Level I, prospective randomized study.

Does Study Design Affect Redislocation Rates After Primary Shoulder Dislocations? A Systematic Review Comparing Prospective and Retrospective Studies.

PURPOSE: To compare recurrence rates between prospectively collected and retrospectively collected data on primary anterior shoulder dislocations, as this could influence the timing of surgical decision making. METHODS: A comprehensive literature search of Medline, Embase, CINAHL, and hand searches was performed. Recurrence rates of anterior shoulder dislocations were collected from relevant articles, along with follow-up length, age, and gender. An independent sample t test was conducted to evaluate our hypothesis. A multiple linear regression model was used to examine the variance in recurrence rates while controlling for covariates. RESULTS: A total of 1,379 articles were identified, of which 25 were relevant to our study-16 prospective and 9 retrospective. The average rate of recurrence of anterior shoulder dislocations in retrospective studies (mean [M] = 45.2, standard deviation [SD] = 31.67) was not significantly different from that in prospective studies (M = 56.7, SD = 22.55). The 95% confidence interval for the difference of the means ranged from -34.05 to 10.91. After controlling for covariates with the multiple linear regression, only 1.9% of the variance in recurrence rates was due to study type and was not significant (P = .42). The t test performed to evaluate our hypothesis was also not significant t(23) = -1.07, P = .298. CONCLUSIONS: When comparing prospective and retrospective studies, there was no significant difference in recurrence rates of primary anterior shoulder dislocations treated nonoperatively. The average redislocation rate was 56.7% in prospective studies and 45.2% in retrospective studies. Furthermore, the majority of this difference was accounted for by varying rates between age groups. Further research is needed to determine the risk of redislocation in specific age groups, to guide treatment decisions based on varying risk. LEVEL OF EVIDENCE: Systematic review of Level II and III studies.

Quality of Life in Bilateral Vs. Unilateral End-Stage Ankle Arthritis and Outcomes of Bilateral Vs. Unilateral Total Ankle Replacement.

BACKGROUND: We performed a retrospective cohort study to compare preoperative health-related quality of life (HRQoL) between patients with bilateral and those with unilateral end-stage ankle arthritis. We also compared midterm outcomes in a subgroup of patients who had undergone staged bilateral total ankle replacement (TAR) with the outcomes in the group treated with unilateral TAR. METHODS: The HRQoL before surgical treatment was compared between 53 patients with bilateral end-stage ankle arthritis identified from the Canadian Orthopaedic Foot and Ankle Society Prospective Ankle Reconstruction Database and 106 patients with unilateral arthritis selected from the same database. Short Form-36 (SF-36) and American Academy of Orthopaedic Surgeons Foot and Ankle Module (AAOS-FAM) scores were used to assess preoperative HRQoL. Midterm outcomes (implant survival, HRQoL, and reoperation and revision rates) were compared between 37 patients who had undergone staged bilateral TAR and 106 patients treated with unilateral TAR; all patients were followed for at least 2 years. RESULTS: Preoperatively, patients with unilateral disease had a higher prevalence of posttraumatic arthritis, whereas patients with bilateral disease had a higher prevalence of primary and secondary arthritis (p < 0.001). The mean preoperative SF-36 physical component summary (PCS) score in the unilateral group was higher than that in the bilateral group (p < 0.002). The mean postoperative follow-up (and standard deviation) was 5.0 ± 2.0 years in the bilateral TAR group and 4.0 ± 1.8 years in the unilateral TAR group. The patients who underwent either unilateral or staged bilateral TAR demonstrated improved SF-36 PCS scores between the preoperative and postoperative evaluations (p < 0.001). The postoperative SF-36 PCS scores were similar between the patients with unilateral TAR and those with bilateral TAR (p = 0.70). Six ankles (6%) in the unilateral cohort and 6 ankles (8%) in the bilateral cohort required revision of the metal component (p = 0.52). The mean implant survival time was 10.9 years (95% confidence interval [CI] = 10.1 to 11.7 years) in the bilateral cohort and 9.2 years (95% CI = 8.5 to 9.8 years) in the unilateral cohort (p = 0.60). CONCLUSIONS: Preoperative SF-36 scores demonstrated that bilateral end-stage ankle arthritis is a more debilitating condition than unilateral arthritis. Patients who underwent staged bilateral TAR benefited as much as patients who underwent unilateral TAR, despite having a worse preoperative health status. Metal component revision rates and implant survival were similar between the 2 groups. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Midterm Outcomes of Polyvinyl Alcohol Hydrogel Hemiarthroplasty of the First Metatarsophalangeal Joint in Advanced Hallux Rigidus.

BACKGROUND: Hallux rigidus is the most common arthritic condition of the foot. A randomized clinical trial of first metatarsophalangeal (MTP) joint hemiarthroplasty with a polyvinyl alcohol (PVA) hydrogel implant (Cartiva) demonstrated pain relief and functional outcomes equivalent to first MTP arthrodesis at 2 years postoperation, with no cases of implant fragmentation, wear, or bone loss. We prospectively determined 5-year outcomes of first MTP hemiarthroplasty with the PVA hydrogel implant. METHODS: Patients who underwent first PVA hydrogel MTP hemiarthroplasty in the previously reported trial were evaluated at 5 years postoperatively. Patients underwent physical examination and radiographic evaluation and completed a pain VAS, the Short-Form-36 (SF-36), and the Foot and Ankle Ability Measure (FAAM) sports subscale and activities of daily living (ADL) subscale. At the time of this study, 29 patients had reached 5 years' follow-up. Two were lost to follow-up, leaving 27 patients with mean age 56.1 (range, 40.1-71.9) years. Mean follow-up was 5.4 (range, 4.9-6.4) years. RESULTS: Postoperative active MTP natural joint dorsiflexion and peak MTP dorsiflexion were mean 18.2 (range, 10.0-30.0) and 29.7 (range, 10.0-45.0) degrees, respectively. Pain VAS, SF-36 PCS, FAAM ADL, and FAAM Sports scores demonstrated clinically and statistically significant improvements. Radiographically, no patient demonstrated changes in implant position, implant loosening or subsidence, or implant wear. One implant was removed because of persistent pain and converted to fusion 2 years postoperation. CONCLUSION: Five years following first MTP hemiarthroplasty with a PVA hydrogel implant, functional outcomes improved significantly, pain was reduced significantly, and the implant demonstrated excellent survivorship. LEVEL OF EVIDENCE: Level IV, prospective case series.

Symptom Resolution and Patient-Perceived Recovery Following Ankle Arthroplasty and Arthrodesis.

BACKGROUND: Patients' perception of outcomes is not always defined by the absence of limitations/symptoms (resolution), but can also be characterized by behavioral adaptation and cognitive coping arising in cases with residual deficits. Patient-reported outcome measures (PROs) are designed to measure levels of function or symptoms, largely missing whether patients are coping with ongoing limitations. This study aimed to broaden the conventional definition of a "satisfactory" outcome following ankle reconstruction by comparing patient-reported outcomes of patients with and without residual symptoms and limitations. METHODS: The study consisted of a cross-sectional survey of ankle arthroplasty (n = 85) and arthrodesis (n = 15) patients. Outcome measures included the Ankle Osteoarthritis Scale, Short Musculoskeletal Function Assessment, Short Form-12, and EuroQol-5 Dimension. Patients also completed measures of pain (0-10), stiffness (0-10), satisfaction (0-3), and ability to complete activities of daily living (ADL) (0-6). Based on a self-reported question regarding recovery and coping, patients were categorized as "Recovered-Resolved" (better with no symptoms or residual effects), "Recovered, not Resolved" (RNR, better with residual effects), or "Not Recovered" (not better). Recovery groups were compared across measures. RESULTS: Only 15% of patients were categorized Recovered-Resolved. Most were RNR (69%), leaving 14% Not Resolved. Recovered-Resolved experienced lower rates of pain (1.4 ± 2.3), stiffness (1.1 ± 2.6), and difficulty performing ADLs (0.9 ± 1.2). Overall, outcome measure scores were high (ie, better health) for Recovered-Resolved patients, midrange for RNR patients, and low for Not Recovered patients, thus confirming predefined hypotheses. Recovered-Resolved and RNR patients had similarly high satisfaction summary scores (3.0 ± 0.0 vs 2.6 ± 0.6). CONCLUSION: Most patients reported positive outcomes, but few (15%) experienced resolution of all symptoms and limitations. Current PROs focus on achieving low levels of symptoms and limitations, but miss an important achievement when patients are brought to a level of residual deficits with which they can cope. Patients' perceptions of satisfactory outcomes were not predicated on the resolution of all limitations; thus, the conventional definition of "satisfactory" outcomes should be expanded accordingly. LEVEL OF EVIDENCE: Level II, prospective cohort study.

The impact of obesity on the outcome of total ankle replacement.

BACKGROUND: Obese patients have a slightly higher proportion of revision and infection following knee or hip replacement, but functional improvement is equivalent to that of normal-weight patients. We compared outcomes of total ankle replacement for end-stage ankle arthritis in obese and normal-weight patients. METHODS: This retrospective cohort study compared thirty-nine obese patients (those with a body mass index of ≥30 kg/m(2)) at a mean follow-up time of 3.76 years and forty-eight non-obese patients (those with a body mass index of <30 kg/m(2)) at a mean follow-up time of 3.92 years after total ankle replacement. Outcome measure scores (Ankle Osteoarthritis Scale [AOS] and Short-Form 36 [SF-36]) were collected preoperatively and at least two years postoperatively. Complication and revision data were collected by manual chart audits. Statistical analyses were performed with use of t tests, Wilcoxon signed-rank tests, and Mann-Whitney U tests. Survival analysis was conducted with use of the Kaplan-Meier method. RESULTS: The two cohorts had similar demographic characteristics. Ten (26%) of thirty-nine patients in the obese group were morbidly obese (having a body mass index of >40 kg/m(2)). There were thirty-nine patients in the obese group and forty-eight patients in the non-obese group. The mean body mass index (and standard deviation) was 36.28 ± 5.43 kg/m(2) for the obese group and 25.84 ± 3.00 kg/m(2) for the non-obese group. The obese group had significantly worse preoperative SF-36 Physical Component Summary scores (p = 0.01) than the non-obese group. Preoperatively to postoperatively, both obese and non-obese patients demonstrated significant improvements (p < 0.001) in AOS pain, AOS disability, and SF-36 Physical Component Summary scores, and the changes in these scores were similar for both groups. The SF-36 Mental Component Summary scores did not change significantly (p = 0.30) in either group. There was no significant difference (p = 0.48) in the proportion of complications or revisions between the groups. CONCLUSIONS: Although obese patients had increased disability and worse function preoperatively, total ankle replacement significantly and similarly improved pain and disability scores in both obese and non-obese patients, with no significant difference in the proportion of complications. We therefore maintain that total ankle replacement is a reliable treatment option for patients with end-stage ankle arthritis, including those who are obese. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Reliability and validity of 6 measures of pain, function, and disability for ankle arthroplasty and arthrodesis.

BACKGROUND: Patient-reported outcome measures are increasingly used evaluating clinical care. Many measures used to assess operative hindfoot interventions vary in content, and some have not been psychometrically validated in this population. The purpose of this study was to compare measurement properties of 6 lower-extremity patient-reported outcome measures, and to evaluate their reliability and validity in light of patients' preferences. METHODS: Cross-sectional survey of 42 preoperative and 100 postoperative patients completed 6 lower-extremity outcome measures on 2 occasions: Foot Function Index (FFI), Ankle Osteoarthritis Scale (AOS), patient-reported items of the American Orthopaedic Foot & Ankle Society Questionnaire (AOFAS), Lower Extremity Functional Scale (LEFS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Musculoskeletal Function Assessment (SMFA), as well as measures of preference, and symptoms. RESULTS: Internal consistency was good to excellent for all scales and subscales (α = .84-.97; ICC [2,1] = .81-.96). Correlations between scales ranged from .50 (WOMAC(Stiffness) and FFI(Activity) Limitations) to .92 (LEFS and SMFA(Overall), WOMAC(Pain) and AOS(Overall), FFI(Overall) and AOFAS(Overall)). Higher correlations occurred within instruments (r = .97 AOS(Pain) and AOS(Overall)) and between similar subscales from different instruments (r = .91 WOMAC(Pain) and AOS(Pain)). Construct validity showed moderate to high correlations to global ratings of Pain, Stiffness, and difficulty performing Daily Activities. The highest correlations (r > .75) occurred between Pain and AOS(Overall) (r = .84), stiffness and WOMAC(Stiffness) (r = .81), and Daily Activities and AOS(Disability) (r = .87). Patients rated instruments by preference. FFI, WOMAC, LEFS, and SMFA rated favorably for length. FFI, WOMAC, LEFS, and AOFAS rated high for understandability. FFI was rated by postoperative patients as most likely to capture change due to surgery. SMFA rated the best overall. CONCLUSIONS: Direct comparison of instruments revealed similarity between scales in construct validity and reliability. Patient preferences supported the use of these scales. Foot-specific instruments offered no clear advantage over lower-extremity instruments. LEVEL OF EVIDENCE: Level II, prospective comparative study.