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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_7 | Pages 11 - 11
8 May 2024
Daniels T
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Introduction/Purpose

A randomized clinical trial of first MTP joint hemiarthroplasty with a synthetic cartilage implant demonstrated equivalent pain, function and safety outcomes to first MTP joint arthrodesis at 2 years. Recognizing that many hemiarthroplasty and total toe implants have initially good results that deteriorate over time, the purpose of this study was to prospectively assess the safety and efficacy outcomes for the synthetic cartilage implant population and to determine if the excellent outcomes were maintained at >5 years.

Methods

One hundred nineteen patients were evaluated at 5+ years; 23 could not be reached for follow-up, but implant status was available for 7 of these subjects. Patients completed a pain visual analogue scale (VAS) and Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) scores, preoperatively and at 2, 6, 12, 26, 52, 104 and 260 weeks postoperatively. Minimal clinically important differences are: ≥30% difference for pain VAS, 9 points for FAAM Sports, and 8 points for FAAM ADL. Great toe active dorsiflexion, weight-bearing radiographs, secondary procedures, and safety parameters were evaluated.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 2 - 2
1 Dec 2022
Khan R Halai M Pinsker E Mann M Daniels T
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Preoperative talar valgus deformity increases the technical difficulty of total ankle replacement (TAR) and is associated with an increased failure rate. Deformity of ≥15° has been reported to be a contraindication to arthroplasty. The goal of the present study was to determine whether the operative procedures and clinical outcomes of TAR for treatment of end-stage ankle arthritis were comparable for patients with preoperative talar valgus deformity of ≥15° as compared to those with <15°. We will describe the evolving surgical technique being utilized to tackle these challenging cases.

Fifty ankles with preoperative coronal-plane tibiotalar valgus deformity of ≥15° “valgus” group) and 50 ankles with valgus deformity of <15° (“control” group) underwent TAR. The cohorts were similar with respect to demographics and components used. All TARs were performed by a single surgeon. The mean duration of clinical follow-up was 5.5 years (minimum two years). Preoperative and postoperative radiographic measurements of coronal-plane deformity, Ankle Osteoarthritis Scale (AOS) scores and Short Form (SF)-36 scores were prospectively recorded. All ancillary (intraoperative) and secondary procedures, complications and measurements were collected.

The AOS pain and disability subscale scores decreased significantly in both groups. The improvement in AOS and SF-36 scores did not differ significantly between the groups at the time of the final follow-up. The valgus group underwent more ancillary procedures during the index surgery (80% vs 26%). Tibio-talar deformity improved significantly toward a normal weight-bearing axis in the valgus group. Secondary postoperative procedures were more common in the valgus group (36%) than the controls (20%). Overall, re-operation was not associated with poorer patient outcome scores. Metal component revision surgery occurred in seven patients (three valgus and four controls). These revisions included two deep infections (2%), one in each group, which were converted to hindfoot fusions. Therefore, 94% of the valgus group retained their original components at final follow-up

Thus far, this is the largest reported study that specifically evaluates TAR with significant preoperative valgus alignment, in addition to having the longest follow-up. Satisfactory midterm results were achieved in patients with valgus mal-alignment of ≥15°. The valgus cohort required more procedures during and after their TAR, as well as receiving more novel techniques to balance their TAR. Whilst longer term studies are needed, valgus coronal-plane alignment of ≥15° should not be considered an absolute contraindication to TAR if the associated deformities are addressed.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 21 - 21
1 Dec 2022
Cherry A Montgomery S Brillantes J Osborne T Khoshbin A Daniels T Ward S Atrey A
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In 2020, the COVID-19 pandemic meant that proceeding with elective surgery was restricted to minimise exposure on the wards. In order to maintain throughput of elective cases, our hospital was forced to convert as many cases as possible to same day procedures rather than overnight admission. In this retrospective analysis we review the cases performed as same day arthroplasty surgeries compared to the same period 12 months previous.

We conducted a retrospective analysis of patients undergoing total hip and knee arthroplasties in a three month period between October and December in 2019 and again in 2020, in the middle of the SARS-CoV-2 pandemic. Patient demographics, number of out-patient primary arthroplasty cases, length of stay for admissions, 30-day readmission and complications were collated.

In total, 428 patient charts were reviewed for the months of October-December of 2019 (n=195) and 2020 (n=233). Of those, total hip arthroplasties comprised 60% and 58.8% for 2019 and 2020, respectively. Demographic data was comparable with no statistical difference for age, gender contralateral joint replacement or BMI. ASA grade I was more highly prevalent in the 2020 cohort (5.1x increase, n=13 vs n=1). Degenerative disc disease and fibromyalgia were less significantly prevalent in the 2020 cohort. There was a significant increase in same day discharges for non-DAA THAs (2x increase) and TKA (10x increase), with a reciprocal decrease in next day discharges. There were significantly fewer reported superficial wound infections in 2020 (5.6% vs 1.7%) and no significant differences in readmissions or emergency department visits (3.1% vs 3.0%).

The SARS-CoV-2 pandemic meant that hospitals and patients were hopeful to minimise the exposure to the wards and to not put strain on the already taxed in-patient beds. With few positives during the Coronavirus crisis, the pandemic was the catalyst to speed up the outpatient arthroplasty program that has resulted in our institution being more efficient and with no increase in readmissions or early complications.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 107 - 107
1 Dec 2022
Athar M Khan R Awoke A Daniels T Khoshbin A Halai M
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There is limited literature on the effects of socioeconomic factors on outcomes after total ankle arthroplasty (TAA). In the setting of hip or knee arthroplasty, patients of a lower socioeconomic status demonstrate poorer post-operative satisfaction, longer lengths of stay, and larger functional limitations. It is important to ascertain whether this phenomenon is present in ankle arthritis patients. This is the first study to address the weight of potential socioeconomic factors in affecting various socioeconomic classes, in terms of how they benefit from ankle arthroplasty.

This is retrospective cohort study of 447 patients who underwent a TAA. Primary outcomes included pre-operative and final follow-up AAOS pain, AAOS disability, and SF-36 scores. We then used postal codes to determine median household income using Canadian 2015 census data. Incomes were divided into five groups based on equal amounts over the range of incomes. This method has been used to study medical conditions such as COPD and cardiac disease. These income groups were then compared for differences in outcome measures. Statistical analysis was done using unpaired t-test.

A total of 447 patients were divided into quintiles by income. From lowest income to highest income, the groups had 54, 207, 86, 64, and 36 patients, respectively. The average time from surgery to final follow up was 85.6 months. Interestingly, we found that patients within the middle household income groups had significantly lower AAOS disability scores compared to the lowest income groups at final follow-up (26.41 vs 35.70, p=0.035). Furthermore, there was a trend towards middle income households and lower post-operative AAOS pain scores compared to the lowest income group (19.57 vs 26.65, p=0.063). There was also a trend toward poorer AAOS disability scores when comparing middle income groups to high income groups post-operatively (26.41 vs 32.27, p=0.058). Pre-operatively, patients within the middle-income group had more pain, compared to the lowest and the highest income groups. No significant differences in SF-36 scores were observed. There were no significant differences seen in middle income groups compared to the highest income group for AAOS pain post-operatively. There were no significant differences found in pre-operative AAOS disability score between income groups.

Patients from middle income groups who have undergone TAA demonstrate poorer function and possibly more pain, compared to lower and higher income groups. This suggests that TAA is a viable option for lower socioeconomic groups and should not be a source of discouragement for surgeons. In this circumstance there is no real disparity between the rich and the poor. Further investigation is needed to explore reasons for diminished performance in middle class patients.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 79 - 79
1 Dec 2022
Halai M Pinsker E Daniels T Khoshbin A
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The prevalence of alcohol and opioids in severely injured patients has been widely reported from 30-80%. However, despite the increasing global misuse of stimulant drugs, there is a paucity of literature regarding the presence of stimulant drugs in trauma patients. The primary aim of this study was to define the prevalence of stimulant drugs that were detected in patients who presented to Level One Trauma Centers throughout North America, and their effect on length of stay and mortality.

Our triage criteria for admittance to the regional trauma centre are based on the recommendations by the American College of Surgeons Committee on Trauma, who now recommend toxicology screening on every patient. This was a retrospective analysis of data from the Trauma Quality Improvement Program, including all patients presenting emergently to participating Level 1 Trauma Centers from January 2017 to December 2018. A stimulant drug was defined as the detection of cocaine, amphetamine, or methamphetamine. Adults aged 18-64 years were included. Patient risk factors were included adjusted for in the analysis: age, sex, body mass index (BMI), alcohol screening results and smoking status. Univariate analysis was performed for all variables. Multivariable logistic regression and liner regression were used for mortality and length of stay, respectively.

Of a total of 110,561 patients included in the study, 15,958 patients (14.4%) had positive screens for stimulants. The average age in the stimulants cohort was 40.8 years, with a 77.6% male preponderance, BMI of 26.9, blood alcohol content of 0.07, and ISS of 11.3. The control cohort was comparable, though 71.1% male (p<0.001) Patients who tested positive for stimulants had 1.79 times (95% CI, 1.09-2.93) the odds of dying in the emergency department as the control group (p=0.02). Following transfer from the emergency department, the odds ratio for deaths in hospital (OR=1.02, 95% CI 0.90-1.15) was comparable to the control group (p=0.78). The mean length of stay was significantly higher in the stimulant group (2.84 days) compared to the control group (1.79 days) (p<.001). In the Intensive Care Unit, length of stay was 0.64 days in the stimulant group versus 1.65 in the control (p=0.48).

Stimulant misuse is a relevant issue in the trauma population, associated with a longer hospital stay and higher mortality in the emergency department. The continued routine drug screening of trauma patients may be beneficial in trauma centers, to implement preventative measures and optimise resource allocation.


Bone & Joint Open
Vol. 2, Issue 7 | Pages 545 - 551
23 Jul 2021
Cherry A Montgomery S Brillantes J Osborne T Khoshbin A Daniels T Ward SE Atrey A

Aims

In 2020, the COVID-19 pandemic meant that proceeding with elective surgery was restricted to minimize exposure on wards. In order to maintain throughput of elective cases, our hospital (St Michaels Hospital, Toronto, Canada) was forced to convert as many cases as possible to same-day procedures rather than overnight admission. In this retrospective analysis, we review the cases performed as same-day arthroplasty surgeries compared to the same period in the previous 12 months.

Methods

We conducted a retrospective analysis of patients undergoing total hip and knee arthroplasties over a three-month period between October and December in 2019, and again in 2020, in the middle of the COVID-19 pandemic. Patient demographics, number of outpatient primary arthroplasty cases, length of stay for admissions, 30-day readmission, and complications were collated.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 12 - 12
1 Mar 2021
Glazebrook M Baumhauer J Younger A Fitch D Quiton J Daniels T DiGiovanni C
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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.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 58 - 58
1 Aug 2020
Burgesson B Glazebrook M Daniels T Younger A
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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.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_21 | Pages 19 - 19
1 Dec 2017
Goldberg A Glazebrook M Daniels T de Vries G Pedersen M Younger A Singh D Blundell C Sakellariou A Baumhauer J
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Introduction

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.

Methods

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 (p< 0.05).


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_21 | Pages 17 - 17
1 Dec 2017
Davies H Blundell C Daniels T Glazebrook M Baumhauer J Younger A Le I Pedersen E
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Introduction

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.

Methods

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.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 31 - 31
1 Dec 2016
Younger A Penner M Glazebrook M Goplen G Daniels T Veljkovic A Lalonde K Wing K Dryden P Wong H
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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.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 32 - 32
1 Dec 2016
Pinsker E Inrig T Daniels P Daniels T Beaton D
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Researchers and clinicians measuring outcomes following total ankle replacement (TAR) are challenged by the wide range of outcome measures used in the literature without consensus as to which are valid, reliable, and responsive in this population. This review identifies region- or joint-specific outcome measures used for evaluating TAR outcomes and synthesises evidence for their measurement properties.

A standard search strategy was conducted of electronic databases MEDLINE, EMBASE and CINAHL (to June 2015) to identify foot/ankle measures in use. A best evidence synthesis approach was taken to critically appraise measurement properties [COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)] of identified measures. The review was restricted to English publications and excluded cross-cultural adaptations. Measurement properties collected from each article were coded for validity, reliability, responsiveness, or interpretability. Clinimetric evidence exists for identified measures tested in non-TAR populations, but were not the focus of this review.

The search identified 14 studies to include in the best evidence synthesis with 32 articles providing clinimetric evidence for eight of the measures (one CBO, seven PRO), however only five measures were tested in a TAR population (Foot Function Index, Ankle Osteoarthritis Scale, American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale [AOFAS], Foot and Ankle Outcome Score, Self-Reported Foot and Ankle Score). Five studies provided clinimetric evidence in a TAR population and their methodological quality was assessed: (1) Validity—two good quality studies examining different measures provide moderate evidence supporting construct validity (FFI, AOS, AOFAS self-reported items; SEFAS); (2) Reliability—two good quality studies examining different measures provide moderate evidence supporting internal consistency and test-retest reliability (FFI, AOS, AOFAS self-reported items; FAOS, SEFAS); (3) Responsiveness—three poor quality studies, thus unknown evidence for responsiveness; (4) Interpretability—two studies provide interpretability values (AOS, FFI, AOFAS self-reported items; AOS).

This review offers a basis for choosing the most appropriate instrument for evaluating TAR outcomes. Numerous outcome measures were identified with evidence supporting their use in populations with various foot/ankle conditions, but none have strong evidence supporting use in a TAR population. Measures must have adequate clinimetric properties in all patient groups in which they are applied. Evidence supporting or critiquing an instrument should not be based on studies with poor quality methodology, as identified by this review. Further testing in a TAR population would benefit identified measures with emphasis on adequate sample sizes, testing a priori hypotheses, and evaluating their content validity for a TAR population.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 24 - 24
1 Dec 2016
Younger A Daniels T Wing K Penner M Veljkovic A Wong H Dryden P Glazebrook M
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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.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 29 - 29
1 Dec 2016
Dodd A Khan R Pinsker E Daniels T
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End-stage ankle arthritis (ESAA) is a debilitating disease that does not affect all individuals equally. Gender differences have been identified in patients with end-stage hip and knee arthritis and have stimulated research to explain these findings. The present study was undertaken to examine if gender has a significant effect on pre-operative disability and post-operative outcomes in patients with ESAA.

Patients undergoing ankle arthrodesis (AA) or total ankle replacement (TAR) with minimum 2-year follow-up were identified in the Canadian Orthopaedic Foot and Ankle Society prospective ankle reconstruction database. Demographic data, revision data, patient satisfaction questionnaires, and outcome data using the Ankle Osteoarthritis Scale (AOS) and Short-form 36 (SF-36) health survey were collected.

TAR: 384 patients were included, with 198 females and 186 males. Patient BMI, comorbidities, and duration of follow-up were similar between groups. Males were slightly older at the time of surgery (65.1 vs 62.4 years, p=0.01)). The most common etiology was post-traumatic arthritis for both genders, however females had a higher rate of rheumatoid arthritis (17% vs 5%, p=0.001). Implant types included STAR, Hintegra, and Mobility, and were similar between groups. Preoperatively females had higher rates of pain and disability, demonstrated by lower SF-36 physical component scores (PCS) (31.0 vs 34.5, p<0.001), and higher AOS pain (54.7 vs 51.1, p=0.05) and AOS disability scores (66.5 vs 59.6, p<0.001). Postoperatively, both groups had significant improvement in PCS, AOS pain, and AOS disability scores. Females, however, continued to demonstrate lower PCS scores (38.3 vs 41.9, p<0.001) and higher AOS disability (31.0 vs 25.8, p=0.02) than males. Regression analysis found that preoperative PCS, gender, age, and arthritis etiology all had a significant impact on postoperative PCS scores, with preoperative PCS scores having the largest impact. Preoperative AOS pain and disability scores had the largest impact on postoperative AOS pain and disability scores, respectively. Gender had no significant impact on AOS pain and disability scores postoperatively. Patient satisfaction was similar between males and females postoperatively. Secondary surgery was performed in 13.6% of females and 16.1% of males. Five males and five females underwent revision to arthrodesis.

In patients with ESAA, females tend to have higher pre-operative levels of pain and disability compared to males, which persists post-operatively. This is consistent with the hip and knee arthroplasty literature. This finding may be due to females undergoing surgery at more advanced disease states, arthritis etiology, referral bias, or treatment bias. Both males and females have significant and similar degrees of improvement in pain and disability scores after TAR, and reoperation rates and patient satisfaction rates are similar despite the apparent disparity in outcomes.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_14 | Pages 26 - 26
1 Dec 2015
Baumhauer J Singh D Glazebrook M Blundell C Wansbrough G de Vries G Le I Nielson D Petersen E Sakellariou A Solan M Younger A Daniels T
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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.

Conclusion

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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 29 - 29
1 May 2012
Cadden A Quinn A Daniels T
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Total ankle arthroplasty is used as a treatment for end stage arthritis of the ankle.

Surgical techniques highlight risk of injury to anterior neurovascular structures. No literature highlights injury risk to the posterior neurovascular structures in ankle replacement surgery. Current literature consists of cadaveric study in relation posterior ankle arthroscopy.

A retrospective review was done of ankle MRI's, performed by the senior author in his practice. Studies were included in the study where there was no pathology of the posterior ankle present. Axial, coronal and sagital T1 weighted films were reviewed and measurements of the posterior neurovascular structures and tendons were made in relation to the posterior tibia and medial malleolus in relation to planned tibial and talar cutting planes.

A total of seventy-eight MRI's were included in the study (ages ranged from 22 to 78 years). There were 40 females and 38 males. At the level of the tibial cut the tibial nerve and artery were between two to six millimeters from the posterior surface of the tibia. The flexor hallucis longus (FHL) is located in the midline between the medial malleolus and fibula, closely related to the posterior tibial surface. The flexor digitorum longus (FDL) tendon is located in the posterior medial corner of the ankle. There is a window approx ten millimeters wide between where the neurovascular structures lie between the FDL and FHL tendons. At the level of the talus cut the tibial nerve and artery were between five to 11 mm from the posterior body of the talus.

A similar window is present at this level where the neurovascular structures lie between the FDL and FHL tendons.

The neurovascular structures of the ankle are potentially at risk during the tibial and talar bone resection. They are most at risk with the transverse cut of the tibia. This may be decreased by preventing direct pressure over these structures during bone resection.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 244 - 244
1 May 2009
Daniels T McLaren AM Tamir E
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The purpose of this study was to retrospectively review the outcomes of percutaneous flexor tenotomies of diabetic claw toes with ulcers or pending ulcers.

A retrospective chart review between January 1999 and June 2005 was performed to identify those patients that had undergone a percutaneous flexor tenotomy for diabetic claw toe deformities. Thirty-four toes in fourteen patients were identified. Twenty-four toes had ulcerations at the terminal aspect and three of these had radiographic evidence of osteomyelitis of the terminal phalange. All patients had palpable pulses and good capillary refill. A percutaneous flexor tenotomy was performed in an outpatient clinic on all toes, patients with a rigid flexor contracture at the proximal interphalangeal (PIP) joint underwent an osteoclaysis to correct a portion of the deformity.

The average follow-up was thrirteen months, all patients with ulcers healed and there were no significant complications. Those without osteomyelitis healed within an average of three weeks and those with osteomyelitis healed within an average of eight weeks.

A Percutaneous flexor tenotomy with osteoclasis of the PIP joint performed in an outpatient clinic is a safe and effective method to off-load the tip of the toe such that ulcer healing can occur. The presence of osteomyelitis is not a contraindication for this technique; however, an increased healing time can be expected.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 244 - 244
1 May 2009
Glazebrook M Daniels T Foote CJ Stevens D Trask K Younger A
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The purpose of this study was to compare the clinical outcome of patients treated surgically for end stage ankle arthritis using a total ankle arthroplasty or ankle arthrodesis.

This is a multicentered prospective clinical outcome study of the surgical treatment of patients with EAA using an ankle arthrodesis (n= 117) or total ankle arthroplasty (n= 210). Clinical outcome was assessed using health related quality of life (SF36v2) and joint specific (Foot Function Index, Ankle Osteoarthritis Scale, American Orthopedic Foot and Ankle Hindfoot Scale and the AAOS Foot and Ankle Baseline Questionnaire(version 2000)) outcome scores.

Preoperatively, all patients had significant physical and psychological morbidity. All symptom and functional SF36 subscales were approximately two standard deviations below normal population scores. Approximately 25% of patients were three standard deviations below population values, indicating increased risk of mortality. There was no evidence that age or gender influenced the level of disability. There was a significant improvement in the health related quality of life and the joint specific clinical outcome scores at six and twelve months follow up but no consistent difference was noted between the two cohorts.

This is the first multicentered prospective clinical outcome study that demonstrates equal efficacy for early follow up of patients treated for EAA with total ankle arthroplasty or ankle arthrodesis.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 519 - 519
1 Aug 2008
Tamir E Daniels T Finestone A Nof M
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Introduction: Historically, off-loading forefoot neuropathic ulcers with a total contact cast has been an effective treatment method. However, large neuropathic ulcers located on the plantar aspect of the heel or midfoot have been resistant to the off-loading with total contact casting. Therefore, it is not uncommon for these ulcers to persist for several years leading to eventual infection and/or amputation.

Objective: To assesses a new and effective off-loading mode of treatment for hindfoot and midfoot ulcers. The device is composed of a fiberglass cast with a metal stirrup and a window around the ulcer.

Research, Design and Methods: A retrospective study of 14 diabetic and non-diabetic patients was performed. All had a single chronic planter hindfoot or midfoot neuropathic ulcer that failed to heal via the conventional methods. A fiberglass total contact cast with a metal stirrup was applied. A window was made over the ulcer so as to continue with daily ulcer care. The cast was changed every other week.

Results: The average duration of ulcer prior to application of the metal stirrup was 26 ± 13.2 months (range 7 to 52 months). The ulcer completely healed in 12 of the 14 patients (86%) treated. The mean time for healing was 10.8 weeks for the midfoot ulcers and 12.3 weeks for the heel ulcers. Complications developed in 4 patients: 3 developed superficial wounds and 1 developed a full thickness wound. In 3 of these 4 patients, local wound care was initiated and the Stirrup cast was continued to complete healing of the primary ulcer.

Conclusion: The fiberglass cast with a metal stirrup is an effective off-loading device for midfoot and hindfoot ulcers. It is not removable and does not depend on patient’s compliance. The window around the ulcer allows for daily wound care, drainage of secretions and the use of VAC treatment. The complication rate is comparable to that of Total Contact Casting.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 88 - 88
1 Mar 2008
Scharfenberger A Pearce D Daniels T
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CT scans of thirty pes planus and eighteen normal feet were obtained in a simulated weight-bearing mode at 50% of body weight. The navicular skin distance was 22% less (1.9vs2.5cm) in the pes planus feet and forefoot supination was only 50% of normal (8.9vs18.6 degrees). Subtalar subluxation was observed in only the most severe pes planus feet. Navicular skin distance relates to medial arch collapse; loss of forefoot supination reflects the rigidity of the forefoot compensation to hindfoot valgus. Severe pes planus results in subtalar subluxation. The radiological indices described have not previously been reported in the literature.

To compare the inter-tarsal relationships of the pes planus foot to the normal foot in the weight-bearing state.

Weight-bearing CT scan of the feet is a practical examination with rapid set-up and minimal patient discomfort. Preliminary results demonstrate differences in the inter-tarsal relationships of pes planus feet compared to normal feet. Better understanding of pes planus deformity will advance clinical evaluation and treatment strategies.

Radiological indices described have not previously been reported in the literature.

Thirty pes planus and eighteen normal feet were imaged. All patients were able to tolerate the six- minute exam at 50% of body weight. Total study time averaged fifteen minutes. The navicular skin distance was 22% less (1.9vs2.5 cm) in pes planus feet compared to normal feet. Pes planus feet had only 50% of the normal forefoot supination (8.9vs18.6 degrees). Lastly, subtalar joint subluxation was observed in only the most severe pes planus feet. Values ranged from 0.2 to 1.1cm.

Axial CT images of 1mm thickness with 0.5mm overlap were obtained at a weight-bearing load of 50% of body weight using the weight-bearing CT device. Coronal and Sagital images were then reconstructed.

Radiological indices obtained can be related to the clinical picture of the pes planus foot. The navicular skin distance reflects medial arch collapse, where as the lack of forefoot supination reflects the rigidity of the forefoot compensation to hindfoot valgus. Severe hindfoot valgus in pes planus results in subtalar sub-luxation.