Autologous bone has been the gold standard for grafting material in foot and ankle arthrodesis. While autograft use has been effective, the harvest procedure does present risks to the patient including readmission, infection, and persistent graft harvest site pain. Previous studies have examined graft harvest site pain, but most have focused on the iliac crest and none have long term follow-up. The purpose of this study was to examine long-term (7–10 year) harvest site pain in subjects undergoing autograft harvest from multiple sites for hindfoot and/or ankle arthrodesis. Sixty (60) subjects underwent hindfoot or ankle arthrodesis supplemented with autograft as part of the control arm of a prospective, randomized trial. The mean subject age was 59.4 years (range, 24.7–76.8) and mean body mass index was 30.6 kg/m2 (range, 22.0–44.0). There were 29 males and 31 female subjects. Subjects had the tibiotalar (37.9%), subtalar (24.1%), talonavicular (10.3%), subtalar/talonavicular (5.1%), or subtalar/calcaneocuboid/talonavicular (22.4%) joints arthrodesed. Autograft was harvested from either the proximal tibia (51.7%), iliac crest (17.2%), calcaneous (15.5%), distal tibia (6.8%), or other location (8.6%). Graft harvest site pain was evaluated using a 100-point visual analog score (VAS), with clinically significant pain being any score greater than 20. Subjects were followed a mean of 9.0 years (range, 7.8–10.5). The percentage of subjects who reported clinically significant pain was 35.7%, 21.4%, 18.2%, 10.5%, 8.9%, and 5.2% at 2, 6, 12, 24, 52 weeks, and final follow-up (7.8–10.5 years), respectively. The mean VAS autograft harvest site pain at final follow-up was 4.4 (range, 0.0–97.0), with 37.9% of subjects reporting at least some pain. For three subjects (5%) with clinically significant pain (VAS >20) at final follow-up, two had proximal tibial harvest sites and one had an iliac crest harvest site. There was no correlation between graft volume and harvest site pain. This study is the first to examine long-term pain following autologous bone graft harvest for hindfoot and/or ankle arthrodesis. Over a third of patients reported having some pain at an average follow-up of nine years, with 5% experiencing clinically significant pain. The results of this study suggest that harvesting autograft bone carries a risk of persistent, long-term pain regardless of the volume of graft that is harvested. This potential for persistent pain should be considered when informing patients of procedure risks and when deciding to use autograft or a bone graft substitute material.
Anesthetic peripheral nerve blocks (PNB) have been shown to be more advantageous than general anesthesia in a variety of surgical operations. In comparison to conventional methods of general anesthesia, the choice of regional localized infiltration has been shown to shorten hospital stays, decrease hospital readmissions, allow early mobilization, and reduce narcotic use. Perioperative complications of PNBs have been reported at varying rates in literature. Thus, the purpose of this study was to provide a review on the clinical evidence of PNB complications associated with foot and ankle surgeries. A systematic review of the literature was completed using PubMed search terms: “lower extremity”, “foot and ankle”, “nerve block”, and “complications”. All studies reporting minor and major complications were considered along with their acute management, treatments, and postoperative follow up timelines. The range of complications was reported for Sensory Abnormalities, Motor Deficits, Skin and systemic complications (local anesthetic systemic toxicity & intravascular injections). A designation of the scientific quality (Level I-IV) of all papers was assigned then a summary evidence grade was determined. The search strategy extracted 378 studies of which 38 studies were included after criteria review. Block complications were reported in 20 studies while 18 studies had no complications to report. The quality of evidence reviewed ranged from Level I to Level IV studies with follow up ranging from twenty four hours to one-three year timelines. The range of complications for all studies reporting sensory abnormalities was 0.53 to 45.00%, motor deficits 0.05 to 16.22% and skin and systemic complications 0.05 to 6.67%. Sensory abnormalities that persisted at last follow up occurred in six studies with incidence ranging from 0.23 to 1.57%. Two studies reported motor complications of a foot drop with an incidence of 0.05% and 0.12%. When considering only the highest quality studies (Level 1) that had complications to report, the complications rate was 10.00% to 45.00% for sensory abnormalities, 7.81 to 16.22% for motor deficits, 6.67% for skin complications and 2.50% for systemic complications. High quality studies (Level I providing Summary Grade A Evidence) reporting all complications with a range of incidence from 0 to 45%. While most of these complications were not serious and permanent, some were significant including sensory abnormalities, foot drop and CRPS. Based on this systematic review of the current literature, the authors emphasize a significant rate of complications with PNB and recommend that patients are appropriately informed prior to consenting to these procedures.
Ankle arthrodesis and replacement are the widely accepted options in managing end-stage ankle arthritis. Ankle replacement as an alternate treatment option for ankle arthritis is relatively new and this is in large part to the successes observed with hip and knee arthroplasty for arthritis. Relative benefits of ankle replacement and arthrodesis remains a contentious topic. We conducted a multicenter pilot randomized controlled trial, first of its kind, comparing the clinical outcomes of ankle arthrodesis and ankle replacement in managing ankle arthritis. We hypothesized that clinical outcomes would be similar for both. Patients recruited for this study were part of Canadian Orthopaedic Foot and Ankle Society (COFAS) Database. Canadian orthopaedic surgeons with fellowship training in foot and ankle surgery or extensive experience in the surgical treatment of end stage ankle arthritis determined whether the patient met the criteria for randomization, skeletal maturity, symptomatic ankle arthritis no longer amenable to non-operative management, and ability to give informed consent. Data was collected on patient demographics, follow-up time period, complication rates, and Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36) scores. Our analysis of clinical outcomes was divided into two parts: (1) comparison of pre and postoperative data for each cohort separately, and (2) comparison of outcome scores, and revision rates between both cohorts. We employed the Student's t-test and calculated effect sizes in assessing improvements in AOS and SF-36 scores from baseline to latest follow-up within and between the two groups. We also examined postoperative complication and reoperation rates in the study population using the standardized coding system for reoperations following ankle replacement and arthrodesis. Thirty-nine ankles were enrolled in the study with a mean follow-up of 5.1 ± 2.8 years. Ankle osteoarthritis scale scores improved significantly from baseline and last follow-up in both groups. The average baseline AOS total score for ankle replacement improved from 59.4 ±15.9 to 38 ±20 at last follow-up (p-value 19.7 to 31.8 ±16.5 at last follow-up (p-value 25.4 compared to ankle replacement's 20.3 ±23. Two major complications (10.5%) were observed in the ankle replacement cohort while the ankle arthrodesis cohort saw four major complications (20%). Clinical outcomes of ankle replacement and arthrodesis were comparable. The ankle arthrodesis cohort held a slight advantage over ankle replacement in improvement of AOS scores, though not statistically significant. Rates of major complications and reoperations were higher with ankle arthrodesis.
Studies have compared outcomes of first metatarsophalangeal joint (MTPJ1) implant hemiarthroplasty and arthrodesis, but there is a paucity of data on the influence of patient factors on outcomes. We evaluated data from a prospective, RCT of MTPJ1 implant hemiarthroplasty (Cartiva) and arthrodesis to determine the association between patient factors and clinical outcomes. Patients ≥18 years with Coughlin hallux rigidus grade 2, 3, or 4 were treated with implant MTPJ1 hemiarthroplasty or arthrodesis. Pain VAS, Foot and Ankle Ability Measure (FAAM) Sports and ADL, and SF-36 PF scores were obtained preoperatively, and at 2, 6, 12, 24, 52 and 104 weeks postoperatively. Final outcomes, MTPJ1 active peak dorsiflexion, secondary procedures, radiographs and safety parameters were evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. Composite primary endpoint criteria for clinical success included pain reduction ≥30%, maintenance/improvement in function, and no radiographic complications or secondary surgical intervention at 24 months. Predictor variables included: grade; gender; age; BMI; symptom duration; prior MTPJ1 surgery; preoperative hallux valgus angle, ROM, and pain. Two-sided Fisher's Exact test was used (Introduction
Methods
A randomized clinical trial of first metatarsophalangeal (MTP) joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. The implant cohort continues to be followed under an extension of the original study and we report on prospectively determined 5+ year outcomes for subjects assessed to date. Patients treated with hemiarthroplasty implant as part of the previously mentioned trial are eligible for enrollment in the extended study (n=135). At the time of this report, 57 patients had reached the 5+ years postoperative time point, of which 5 were lost to follow-up. The remaining 52 patients with mean age of 58.5 (range, 38.0–0.0) underwent physical examination, radiographic evaluation, assessment of implant survivorship and collection of patient completed VAS pain, and Foot and Ankle Ability Measure (FAAM) sports subscale and activities of daily living (ADL) subscale scores. Mean follow-up is 5.8 (range, 4.8–8.4) years.Introduction
Methods
Reoperations may be a better way of tracking adverse outcomes than complications. Repeat surgery causes cost to the system, and often indicate failure of the primary procedure resulting in the patient not achieving the expected improvement in pain and function. Understanding the cause of repeat surgery at the primary site may result in design improvements to implants or improvements to fusion techniques resulting in better outcomes in the future. The COFAS group have designed a reoperation classification system. The purpose of this study was to outline the inter and intra observer reliability of this classification scheme. To verify the inter- and intra-observer reliability of this new coding system, six fellow ship trained practicing foot and ankle Orthopaedic surgeons were asked to classify 62 repeat surgeries from a single surgeons practice. The six surgeons read the operation reports in random order, and reread the reports 2 weeks later in a different order. Reliability was determined using intraclass correlation coefficients (ICC) and proportions of agreement. The agreement between pairs of readings (915 for inter observer for the first and second read – 61 readings with 15 comparisons, observer 1 with observer 2, observer 1 with observer 3, etc) was determined by seeing how often each observer agreed. This was repeated for the 366 ratings for intra observer readings (61 times 6). The inter-observer reliability on the first read had a mean intra-class correlation coefficient (ICC) of 0.89. The range for the 15 comparisons was 0.81 to 1.0. Amongst all 1830 paired codings between two observers, 1605 (88%) were in agreement. Across the 61 cases, 45 (74%) were given the same code by all six observers. However, the difference when present was larger with more observers not agreeing. The inter-observer reliability test on the second read had a mean ICC of 0.94, with a range of 0.90. There were 43 (72%) observations that were the same across all six observers. Of all pairs (915 in total) there was agreement in 804 pairs for the first reading (88%) and disagreement in 111 (12%). For the second reading there was agreement in 801 pairs (86%) and disagreement in 114 (14%). The intra-observer reliability averaged an ICC value of 0.92, with a range of 0.86 to 0.98. The observers agreed with their own previous observations 324 times out of 366 paired readings (89% agreement of pairs). The COFAS classification of reoperations for end stage ankle arthritis was reliable. This scheme potentially could be applied to other areas of Orthopaedic surgery and should replace the Claiden Dindo modifications that do not accurately reflect Orthopaedic outcomes. As complications are hard to define and lack consistent terminology reoperations and resource utilisation (extra clinic visits, extra days in hospital and extra hours of surgery) may be more reliable measures of the negative effects of surgery.
Patients often comment on swelling after foot and ankle surgery. However the relationship between swelling and outcome (pain and function) has not previously been outlined. A recent study by Pinsker and Daniels demonstrated that while swelling was rated as important by patients it was rarely included in outcome scores. The purpose of this paper was to determine the relationship between swelling and outcome after ankle fusion or replacement. A secondary purpose was to determine how this relationship changed in time, how swelling score changed before and after surgery, and determine differences in swelling score between total ankle replacement (TAR), open ankle arthrodesis (OAA) and arthroscopic ankle arthrodesis (AAA). The COFAS prospective ankle arthritis database enrolls patients in 4 centers undergoing surgery by one of 6 surgeons since 2002. The MODEMS outcomes package from AAOS was used, with the validated ankle osteoarthritis score (AOS) score being used to assess outcomes in the pain and disability domains. The swelling score was indexed from 1 to 5, 1 being no swelling and 5 being severe swelling. Outcomes were recorded preoperatively and annually up to 2010. Statistical analysis was performed using 95% confidence intervals and correlations being determined using Pearson's correlation and r2 values. The swelling score was correlated with AOS score with an r2 of 0.13 for postoperative patients. With the swelling score analysed categorically the difference of outcome was significant with a mean AOS score of 15.1 (CI 13.3 to 16.9) for a swelling score of 1, 23 (CI 21.7 to 24.9) for a swelling score of 2, 31 (CI 29.6 to 33.1) for 33.6 (CI 34.9 to 38.8) for 4, and 39 (CI 35.3 to 43.0) for 5. Swelling scores fell outside the 95% confidence intervals for all groups indicating that the AOS outcome of swelling score 5 patients was worse than the 4 group, 4 worse than 3, 3 worse than 2, and 2 worse than 1. Patients with swelling scores of 1 scored 24 points better than those with a swelling score of 5. Swelling scores were the same preoperatively for total ankle arthroplasty, Arthroscopic and open fusions. However swelling scores were lower for arthroscopic fusions after surgery for all time periods at an average of 2.1 (CI 1.9 to 2.2), compared to total ankle arthroplasty (2.5, CI 2.4 to 2.6) and open ankle fusion (2.5, CI 2.4 to 2.6). Swelling has a major relationship with outcome. Swelling may be the cause of poorer outcomes for open ankle fusion compared to arthroscopic. Swelling is an independent factor as swelling scores for TAA were higher compared to AAA despite similar outcomes. Arthroscopic surgery reduces the postoperative swelling. Methods to reduce swelling such as compression stockings, elevation, controlling bleeding may result in better outcomes. Minimising the invasiveness of surgery achieves this goal. Patient education about swelling, elevation and compression stockings would assist in these goals.
Patients with advanced stage hallux rigidus from 12 centers in Canada and the UK were randomized (2:1) to treatment with a small (8/10 mm) hydrogel implant (Cartiva) or 1st MTP arthrodesis. VAS pain scale, validated outcome measures (FAAM sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment and safety parameters were evaluated. 236 patients were initially enrolled, 17 patients withdrew prior to randomization, 17 patients withdrew after randomization and 22 were non-randomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. Mean VAS pain scores decreased from 6.8 and 6.9 respectively for the implant and arthrodesis groups from baseline to 1.4 and 0.7 at 24 months. Similarly, the FAAM sports score improved significantly from baseline levels of 37 and 36 to 24 months level of 77 and 82 respectively for the implant and arthrodesis groups. First MTP active dorsiflexion motion improved an average of 4° at 3 months after implant placement and was maintained at 24 months. Secondary surgeries occurred in 17 (11.2%) implant patients and 6 (12.0%) arthrodesis patients. Fourteen (9.2%) implants were removed and converted to arthrodesis and 6 (12.0%) arthrodesis patients had painful hardware requiring removal. There was no case of implant fragmentation, wear, or bone loss. Analysis of a single composite endpoint utilizing the three primary study outcomes (pain, function, and safety) showed statistical equivalence between the2groups. In patients requiring surgery for advanced stage hallux rigidus, treatment with a small synthetic cartilage implant resulted in comparable clinically important pain relief and functional outcomes compared to 1st MTP arthrodesis while preserving and often improving great toe motion. Secondary surgical intervention was similar in the implant and arthrodesis groups. Revision from a small implant plug to arthrodesis can be performed if needed.Conclusion
The treatment of acute rupture of the tendo-achilles remains controversial. There is good evidence to suggest that outcomes are the same for both operative and non-operative treatment when a functional rehabilitation program is utilised. However, debate continues as to whether the radiological gap-size between the proximal and distal remnants of the tendon has an influence on the suitability for non-operative management. All adult patients who attended the emergency department with a clinically suspected tendo-achilles rupture were place in a plantarflexed cast, and underwent MRI scanning to confirm the diagnosis. They were then counselled on the risks and benefits of operative versus non-operative treatment. Patients opting for non-operative treatment were asked to take part in the study and treated using a functional rehabilitation programme. Gap sizes were determined using a standardised protocol by a single musculoskeletal radiologist blinded to the clinical outcomes.Introduction:
Methods:
The failure rate of total ankle arthroplasty (TAA) in rheumatoid patients may be higher than in osteoarthritis patients due to the medications used to treat rheumatoid arthritis and the comorbidities associated with this disease. The purpose of this study was to prospectively look at the intermediate-term outcomes of TAA in patients with rheumatoid arthritis and to compare the results to a matched cohort of patients with ankle osteoarthritis undergoing TAA. This study is a prospective, multicentre comparison study of patients two to eight years post-TAA. A cohort of 57 patients with rheumatoid arthritis was identified from the prospective national database of TAAs (RA group). Matched controls were identified in the database using age, type of prosthesis, and follow-up time as matching criteria (OA group). The following data was collected: demographic information, previous and additional surgeries at the time of TAA and major and minor complications including revisions. Generic and disease specific, validated outcome scores collected include the Short-Form 36 (SF36) and Ankle Osteoarthritis Score (AOS).Purpose
Method
The purpose of this study was to assess the clinical outcomes over two years for total ankle arthroplasty (TAA) using Short Form-36, Foot Function Index and Ankle Osteoarthritis Scores, and to compare these with radiostereometric analysis longitudinal migration and inducible displacement results. Twenty patients undergoing TAA implanting the Mobility Total Ankle System (DePuy, Warsaw IN) were assessed at 3mth, 6mth, 1yr and 2yr followup periods by model-based radiostereometric analysis, MBRSA 3.2 (Medis specials, Leiden, The Netherlands), for longitudinal migration (LM) and inducible displacement (ID). The same subjects completed clinical outcome questionnaires at these followup periods for Short Form-36 (SF-36; Physical Component Scores (PCS) and Mental Component Scores (MCS)), Foot Function Index (FFI) and Ankle Osteoarthritis Scores (AOS). Descriptive statistics and Pearson correlations (alpha = 0.05) were calculated using Minitab 15 (Minitab Inc., State College PA).Purpose
Method
The purpose of this study was to assess the biomechanical stability of the a total ankle arthroplasty system using longitudinal migration (LM) and inducible displacement (ID) measures. This study is the first study of its kind to assess total ankle arthroplasty (TAA) implant micromotion using model-based radiostereometric analysis (MBRSA). Twenty patients underwent TAA that implanted the Mobility(TM) (DePuy, Warsaw IN). The mean (SD) age was 60.4 (12.5) and BMI was 29.1 (2.8) kg/m2. One surgeon performed all surgeries. All patients included in this study had given informed consent. Capital Health Research Ethics Board had approved this study. Uniplanar medial-lateral RSA X-ray exams were taken postop (double exam), at six wk, three mth, six mth, one yr and two yr followup times using a supine, unloaded position. Standing medial-lateral exams were taken at three mth, six mth, one yr and two yr followup intervals. LM and ID micromotions were assessed using Model-based RSA 3.2 software (Medis specials, Leiden, The Netherlands). Implant micromotions (x, y, z, Rx, Ry, Rz, MTPM) were determined and assessed for each subject using model-based pose estimation, and the implant-based coordinate system. The Elementary Geometric Shapes module from the Model-based RSA 3.2 software was used to assess the micromotion of the tibial component spherical tip due to implant symmetry.Purpose
Method
Surgical repair is the preferred method of treatment of acute Achilles ruptures in North America because, despite a higher risk of overall complications, it offers a reduced risk of re-rupture. However, more recent trials, particularly those using functional bracing with early range of motion (ROM) have challenged this statement. This meta-analysis aims to compare surgical to conservative treatment in respect to re-rupture, overall complications, return to work, calf circumference and functional outcomes, as well as to examine the effects of early ROM on re-rupture rate. Literature search, data extraction, and quality assessment were conducted by two independent reviewers. Publication bias was assessed using the Eggar and Begg tests. Heterogeneity was assessed using I2 tests. Fixed or random-effects models were used accordingly. Pooled results were expressed as risk ratios, risk differences, and weighted or standardized mean difference, as appropriate. Meta-regression was employed to identify heterogeneity causes. Sub-group analysis was performed to assess the effect of early ROM.Purpose
Method
Ankle We report a prospective comparative clinical study comparing open and arthroscopic ankle arthrodesis at two institutions with two-year follow-up. The primary outcome was the Ankle Osteoarthritis Scale and secondary outcomes included the SF-36, hospital stay and radiographic alignment. A power calculation was performed. There were 30 patients in each group.Background
Methods
Total Ankle Replacement (TAR) is increasingly being offered to patients as an alternative to arthrodesis for the operative management of debilitating end-stage ankle arthritis. The Mobility Total Ankle System is a third-generation design consisting of a three component, cementless, unconstrained, mobile-bearing prosthesis. This study reports the early results of a multi-centre prospective study of the Mobility prosthesis. This is the first such report by independent researchers. The senior authors implanted 86 consecutive Mobility prostheses. The underlying diagnosis was primary OA in 24 ankles, secondary OA in 47 ankles and inflammatory arthritis in 15 ankles. There were 41 males (Mean age 67 / Range 51–87) and 44 females (Mean age 60 / Range 29–72). The mean BMI was 28 (Range 22–36) for males, and 28 (Range 20–39) for females. Previous ankle operations were performed in 24 patients, 22 of which were for fracture fixation. Ankles were classified according to the COFAS end-stage ankle arthritis classification system. Coronal plane deformity was quantified pre-operatively. Clinical outcome was assessed using the AOFAS hindfoot score. Radiological assessment was performed from weight-bearing radiographs, documenting post-operative alignment, osseous integration, edge-loading and heterotopic bone formation. The mean follow-up time was 40 months (Range 30–60). Survival analysis was calculated according to the Kaplan-Meier method. Failure was defined as exchange of any component of the TAR, arthrodesis or amputation.Purpose
Method
To compare Radiostereometric Analysis (RSA) and subjective outcomes of Total Knee Arthroplasty (TKA) and Total Ankle Arthroplasty (TAA). Twenty-five patients were recruited to receive TKA (Zimmer, NexGen LPS Trabecular Metal Monoblock) and 20 patients were recruited to receive TAA (DePuy, Mobility). The tibial component of the TKA and the tibial component of the TAA were followed for two years with RSA with exams postoperatively at six, 12 and 24 months. At two years, inducible displacement RSA at the knee and ankle was also performed. RSA outcomes measured were translations in the anterior-posterior, medial-lateral and distal-proximal directions of both implants. SF-36 outcome questionnaires were completed preoperatively and at each RSA follow-up with the outcome being the mental component score (MCS) and physical component score (PCS). Analysis of variance statistical testing was used to compare RSA outcomes and subjective outcomes.Purpose
Method