Structure, processes, and initial outcomes of The Ottawa Hospital Multi-Specialist Limb-Preservation Clinic and Programme: A unique-in-Canada quality improvement initiative.

In 2017, The Ottawa Hospital initiated a unique-in-Canada quality improvement initiative by opening a novel, multi-specialist limb-preservation clinic. We sought to describe the structure, processes, and initial outcomes of the clinic and evaluate whether it is achieving its mandate of providing high-quality wound clinical care, education, and research. We conducted a descriptive prospective cohort study alongside a nested study of 162 clinic patients requiring serial assessments. There have been 1623 visits, mostly (72.2%) from outpatients. During 17.8% of visits, patients were evaluated by >1 specialist. Therapies provided most often included negative-pressure wound therapy (32.7%), biological wound dressings (21.6%), and total contact casting (18.5%). Furthermore, 1.2% underwent toe/ray amputations or skin grafting in clinic and 22.8% were initiated on antimicrobials. Mixed-effects models suggested that mean wound volumes for those requiring serial assessments decreased by 1.6 (95% confidence interval = -0.86 to -2.27) cm3 between visits. The clinic provided seven rotations to vascular surgery, infectious diseases, dermatology, and palliative care physicians; three nursing preceptorships; and two educational workshops. It also initiated provincial and national vascular health and wound care research initiatives. This study may be used to guide development of other limb-preservation clinics and programmes. Findings support that our programme is achieving its mandate.

Open reduction internal fixation vs non-operative management in proximal humerus fractures: a prospective, randomized controlled trial protocol.

BACKGROUND: Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. METHODS: We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon's Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. DISCUSSION: The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. TRIAL REGISTRATION: ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.

Biomechanical Effects of Hindfoot Alignment in Supination External Rotation Malleolar Fractures: A Human Cadaveric Model.

BACKGROUND: Pressure distribution in the ankle joint is known to be dependent on various factors, including hindfoot alignment. We seek to evaluate how hindfoot alignment affects contact pressures in the ankle joint in the setting of supination external rotation (SER) type ankle fractures. METHODS: SER fractures were created in 10 human cadaver lower extremity specimens, simulating progressive stages of injury: without fracture (step 0), SER fracture and intact deltoid ligament (step 1), superficial deltoid ligament disruption (step 2), and deep deltoid ligament disruption (step 3). At each step, varus and valgus alignment was simulated by displacing the calcaneal tuberosity 7 mm medial or lateral. Each limb was axially loaded following each osteotomy at a static load of 350 N. The center of force (COF), contact area (CA), and peak contact pressure (PP) under load were measured, and radiographs of the ankle mortise were taken to analyze the medial clear space (MCS) and talar tilt (TT). RESULTS: The COF (5.3 mm, P = .030) and the CA (-188.4 mm2, P = .015) changed in step 3 in the valgus hindfoot alignment compared to baseline parameters, indicating the importance of deep deltoid ligament integrity in maintaining normal ankle joint contact stress in the valgus hindfoot. These changes were not seen in the setting of varus alignment (COF: 2.3 mm, P = .059; CA -121 mm2, P = .133). PP were found to not change significantly in either varus or valgus (varus: -4.9 N, P = .132; valgus: -4 N, P = .464).The MCS demonstrated widening in step 3 compared to step 2 (0.7 mm, P = .020) in both varus and valgus hindfoot. The TT increased significantly in step 3 in the valgus hindfoot (2.8 degrees, P = .020) compared to step 0. CONCLUSION: SER-IV fractures with valgus hindfoot alignment showed significant changes in pressure distribution and radiographic parameters when compared to SER-IV fractures with varus hindfoot alignment. CLINICAL RELEVANCE: Based on this cadaver modeling study, patients with SERIV fracture with varus hindfoot alignment and complete deltoid ligament lesion may not need fracture fixation, whereas those with valgus hindfoot alignment likely need fracture fixation.

A prospective pilot study of B2A-coated ceramic granules (Amplex) compared to autograft for ankle and hindfoot arthrodesis.

BACKGROUND: To reduce fusion nonunion, autogenous bone graft is often incorporated into foot and ankle fusion procedures. B2A peptide-coated ceramic granules, with encouraging results in pilot studies of transforaminal lumbar interbody fusion, were here reformulated into Amplex with a coating concentration of 225 µg B2A/cm(3) ceramic granules (B2A-granule) with the goal of eliminating autogenous bone graft in foot and ankle arthrodesis. The purpose of this study was to perform a multicenter prospective randomized pilot clinical trial designed to compare the safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery. METHODS: This study was a multicenter, prospective, randomized, pilot clinical trial designed to compare safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery. Twenty-four patients were enrolled and randomized (1:1) into 2 groups: autogenous bone graft control and B2A-granule. Primary outcome measures at 6 months (with follow-up at 9 and 12 months) included radiographic fusion assessed by computerized tomography and Ankle Osteoarthritis Scale scores for pain and disability. RESULTS: Radiographic fusion success rates were similar in both groups (100% in the B2A-granule group, 92% autograft). Both the B2A-granule group and the autograft group had improvements in the pain and disability scores over the course of the study. Graft harvest-site pain affected only autograft-treated patients. There were no adverse events attributed to the graft material in either the B2A-granule or autograft group. CONCLUSION: The results of this pilot study are supportive of a larger clinical trial to assess the safety and efficacy of B2A-granule as a bone graft substitute in foot and ankle fusions. LEVEL OF EVIDENCE: Level II, prospective comparative study.

Accuracy of a Patient-Specific Total Ankle Arthroplasty Instrumentation.

BACKGROUND: Total ankle arthroplasty (TAA) is a preferred surgical option for end-stage ankle osteoarthritis; however, it is a demanding procedure with a higher historical rate of revision compared with ankle fusion. Patient-specific instrumentation (PSI) has been introduced to optimize prosthesis alignment and theoretically overall improve TAA outcomes. The goal of this study is to report on the experience and surgical outcomes of one implant with specific evaluation of the accuracy and reproducibility of the system with respect to prosthesis alignment and prediction of implant size. METHODS: A retrospective, multicentered study involving 4 foot and ankle fellowship-trained orthopaedic surgeon's patients undergoing TAA between January 1, 2015, and December 31, 2018, using the PROPHECY PSI system. RESULTS: 80 TAA procedures were performed. On average the postoperative tibial component alignment was 89.9 (range, 86.1-96.5) degrees in the coronal plane, with a mean sagittal alignment of 88.1 (range, 81.3-96.7) degrees. The mean deviation from neutral sagittal alignment improved from 4.9 ± 3.9 degrees preoperatively to 2.7 ± 1.7 degrees postoperatively, whereas the mean coronal alignment improved from 3.3 ± 2.5 degrees to 1.3 ± 1.1 degrees. The PSI software correctly determined the tibial implant size in 70 patients (89%). Prediction of talar implant sizing was less accurate than the tibial component, with 56 patients (71%) using the predicted sized implant. The overall implant survival at a mean follow-up of 45 months (range, 27-76) was 97.5%. CONCLUSION: We found that this PSI system accurately and reliably assisted in implant total ankle prosthesis positioning within a clinically acceptable margin and without significant outliers. Prediction of implant size was not as accurate as component orientation. LEVEL OF EVIDENCE: Level III, retrospective study.

Posterior malleolus exposure.

Objectives: Posterior malleolus (PM) fractures are common in rotational ankle injuries, tibial plafond fractures, and distal third tibia fractures. Surgical indications continue to evolve as we improve our understanding of ankle and syndesmotic stability. These fractures remain technically challenging with respect to both exposure and fixation. Our biomechanical cadaveric study compared posterolateral versus modified posteromedial surgical approaches to define the following: maximal surface area exposed, and maximal screw trajectory obtainable for fixation. Methods: Twelve fresh-frozen cadaver limbs were thawed at room temperature. Posterolateral and modified posteromedial approaches were performed on each limb. Margins of exposure were marked. A 2.5 mm drill was advanced at the extreme medial and lateral extents of each exposure, standardized at 1 cm proximal to the joint line and perpendicular to the bone. Computed tomography (CT) scans were performed to identify the maximal trajectory. Limbs were stripped of soft tissue, and the exposed bony surface area was measured using a validated laser surface-scanning technique. Results: The modified posteromedial approach allowed for a larger exposed surface area compared to the posterolateral exposure (median 99% vs 64%, respectively; P < .05). The modified posteromedial approach allowed for instrumentation of up to a median of 77% of the posterior distal tibia as opposed to 46% through the posterolateral approach (P < .05). Conclusion: The modified posteromedial approach allowed for increased exposure and wider access for instrumentation of the PM when compared to the posterolateral approach. We advocate use of this approach when addressing complex PM fractures, in particular the Haraguchi type 2 fracture pattern.

Faculty Development- Is Some Better Than None?

This article was migrated. The article was marked as recommended. Introduction: With the advent of competency-based medical education there is an emphasis on formative workplace based assessment. The quality of these assessments is a concern for medical educators and their trainees. Faculty development (FD) strategies to improve assessment quality have resulted in some success. However, few faculty participate, and those who do are likely more motivated to improve, making it difficult to demonstrate a conclusive benefit. To address these weaknesses, we designed a FD initiative to improve the quality of completed in-training evaluation reports (ITERs). All faculty within a division participated. We hypothesized that clinical supervisors would improve their ITER quality based on feedback, regardless of their own motivation to do so, with a simple, point-in-time intervention. Methods: In this three-phase study, two independent raters used the Completed Clinical Evaluation Report Rating (CCERR) to assess the quality of ITERs completed by all faculty in the Division of Orthopedic Surgery at the University of Ottawa. In phase one, ITERs from the previous nine months were evaluated. In phase two, the participants were aware that their ITERs were being evaluated, but they did not receive feedback. In phase three, participants received regular feedback on their performance in the form of their mean CCERR scores. Mean CCERR scores from the different phases of the study were compared. Results: CCERR scores were similar for all three phases (one: 17.56 ± 1.02, two: 17.65 ± 0.96, three: 17.54 ± 0.75, p=0.98). Discussion and Conclusions: There was no evidence in our study that participants' improved their ITER quality despite being aware that they were being evaluated and/or receiving feedback. Potentially, this was related to a lack of motivation. Alternatively, the intensity and/or frequency of the feedback may have been inadequate to create change. These results raise concerns that some faculty development may not necessarily be better than none.

Kinematic analysis of the agility total ankle during gait.

BACKGROUND: With the increasing use of total ankle prostheses, kinematic analysis of these implants is important to our understanding of their specific biomechanics. Fluoroscopic analysis as used in this study has distinct advantages over previous experimental approaches and allows kinematic determination in vivo of dynamic weightbearing motions. METHODS: Ten patients with unilateral Agility (Depuy, A Johnson & Johnson Company, Warsaw, IN) total ankle replacements were tested using video fluoroscopy in weightbearing dynamic gait conditions. Their prosthetic ankle and normal ankle kinematics were then analyzed by computer with two-dimensional and three-dimensional model-fitting techniques. RESULTS: All of the total ankle prostheses in this study demonstrated less than 3.5 mm of posterior-to-anterior translation from heel strike to toe-off. In comparison, more variability was seen in posterior-to-anterior motion of the normal contralateral ankles, with three ankles translating more than 6 mm. When inversion and eversion and internal and external rotation of the ankle were measured, wide variations were seen among patients. CONCLUSIONS: While the relative incongruence theoretically decreases the shear stresses transmitted to the bone-prosthesis interface, it does allow more inversion-eversion and rotational freedom that can lead to edge loading and higher contact stresses. Despite good medium-term results having been published for this prosthesis, polyethylene wear and osteolysis have been observed. Further studies looking at the effect of the inversion and eversion and rotational freedom on polyethylene wear and prosthesis survival will assist in our understanding of the factors leading to successful outcome of total ankle prostheses.

A Coding System for Reoperations Following Total Ankle Replacement and Ankle Arthrodesis.

BACKGROUND: Repeated surgery can be a measure of failure of the primary surgery. Future reoperations might be avoided if the cause is recognized and procedures or devices modified accordingly. Reoperations result in costs to both patient and the health care system. This paper proposes a new classification system for reoperations in end-stage ankle arthritis, and analyzes reoperation rates for ankle joint replacement and arthrodesis surgeries from a multicenter database. METHODS: A total of 213 ankle arthrodeses and 474 total ankle replacements were prospectively followed from 2002 to 2010. Reoperations were identified as part of the prospective cohort study. Operating reports were reviewed, and each reoperation was coded. To verify inter- and intraobserver reliability of this new coding system, 6 surgeons experienced in foot and ankle surgery were asked to assign a specific code to 62 blinded reoperations, on 2 separate occasions. Reliability was determined using intraclass correlation coefficients (ICCs) and proportions of agreement. RESULTS: Of a total of 687 procedures, 74.8% (514/687) required no reoperation (Code 1). By surgery type, 14.1% (30/213) of ankle arthrodesis procedures and 30.2% (143/474) of ankle replacement procedures required reoperation. The rate for reoperations surrounding the ankle joint (ie, Codes 2 and 3) was 9.9% (21/213) for ankle arthrodesis versus 5.9% for ankle replacement (28/474). Reoperation rates within the ankle joint (ie, Codes 4 to 10) were 4.7% (10/213) for ankle arthrodesis and 26.1% (124/474) for ankle replacement. Overall, 0.9% (2/213) of arthrodesis procedures required reoperation outside the initial operative site (Code 3), versus 4.6% (22/474) for total ankle replacement. The rate of reoperation due to deep infection (Code 7) was 0.9% (2/213) for arthrodesis versus 2.3% (11/474) for ankle replacement. Interobserver reliability testing produced a mean ICC of 0.89 on the first read. The mean ICC for intraobserver reliability was 0.92. For interobserver, there was 87.9% agreement (804/915) on the first read, and 87.5% agreement (801/915) on the second. For the intra observer readings, 88.5% (324/366) were in agreement. CONCLUSIONS: The new coding system presented here was reliable and may provide a more standardized, clinically useful framework for assessing reoperation rates and resource utilization than prior complication- and diagnosis-based classification systems, such as modifications of the Clavien Dindo System. Analyzing reoperations at the primary site may enable a better understanding of reasons for failure, and may therefore improve the outcomes of surgery in the future. LEVEL OF EVIDENCE: Level III, retrospective comparative cohort study based on prospectively collected data.

Patient expectation and satisfaction as measures of operative outcome in end-stage ankle arthritis: a prospective cohort study of total ankle replacement versus ankle fusion.

BACKGROUND: Current operative outcome scales are based on pain and function, such as the Ankle Osteoarthritis Scale (AOS). Outcomes based on patient expectation and satisfaction may be more useful. The purpose of this prospective cohort study was to evaluate associations between patient expectation, satisfaction, and outcome scores for ankle fusion and total ankle replacement (TAR). METHODS: In total, 654 ankles in 622 patients were analyzed at a mean of 61 months. Patient expectation and satisfaction with symptoms were quantified pre- and postoperatively using the Musculoskeletal Outcomes Data Evaluation and Management Scale questionnaires from the American Academy of Orthopaedic Surgeons, while function was quantified using the AOS. RESULTS: Patients undergoing ankle replacement had a higher preoperative expectation score (79; 95% confidence interval [CI], 77-81) compared with those undergoing ankle fusion (72; 95% CI, 68-75). Preoperative expectation scores correlated weakly with AOS scores (R (2) = 0.02) and with the "expectations met" score for ankle fusion (R (2) = 0.07) but not for ankle replacement (R (2) < 0.01). Satisfaction scores were similar for ankle fusion and ankle replacement at follow-up, but a greater number of ankle replacement patients showed improvement in satisfaction (84% vs 74%, P < .005). Higher satisfaction at final follow-up was associated with better expectations met and greater improvement in AOS outcome scores for both ankle fusion and ankle replacement. Expectations met and AOS scores at follow-up correlated for ankle fusion (R (2) = 0.38, P < .0001) and ankle replacement (R (2) = 0.31, P < .0001). CONCLUSIONS: Patients undergoing TAR had higher expectation scores prior to surgery than those undergoing ankle fusion. Expectations may be more likely to be met by ankle replacement compared with ankle fusion. Ankle replacement patients were more likely to report improved satisfaction scores after surgery. Preoperative expectation scores showed little correlation with preoperative AOS scores, indicating that expectation is independent of pain and function. However, postoperative expectations met and satisfaction scores were strongly associated with AOS scores at follow-up. Better preoperative patient education may change expectations and requires study. LEVEL OF EVIDENCE: Level II, prospective cohort study.

Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a ß-TCP-Collagen Matrix.

BACKGROUND: Ankle and hindfoot arthrodesis is often supplemented with autograft to promote bony union. Autograft harvest can lead to increased perioperative morbidity. Purified recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) has stimulated bone formation in mandibular defects and hindfoot fusion. This randomized controlled trial evaluated the efficacy and safety of rhPDGF-BB combined with an injectable, osteoconductive beta-tricalcium phosphate (ß-TCP)-collagen matrix versus autograft in ankle and hindfoot fusions. METHODS: Seventy-five patients requiring ankle or hindfoot fusion were randomized 5:1 for rhPDGF-BB/ß-TCP-collagen (treatment, n = 63) or autograft (control, n = 12). Prospective analysis included 142 autograft control subjects from another clinical trial with identical study protocols. Standardized operative and postoperative protocols were used. Patients underwent standard internal fixation augmented with autograft or 0.3 mg/mL rhPDGF-BB/ß-TCP-collagen. Radiologic, clinical, and quality-of-life outcomes were assessed over 52 weeks. Primary outcome was joint fusion (50% or more osseous bridging on computed tomography) at 24 weeks. Secondary outcomes included radiographs, clinical healing status, visual analog scale pain score, American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Scale score, Foot Function Index score, and Short Form-12 score. Noninferiority P values were calculated. RESULTS: Complete fusion of all involved joints at 24 weeks as indicated by computed tomography was achieved in 53 of 63 (84%) rhPDGF-BB/ß-TCP-collagen-treated patients and 100 of 154 (65%) autograft-treated patients (P < .001). Mean time to fusion was 14.3 ± 8.9 weeks for rhPDGF-BB/ß-TCP-collagen patients versus 19.7 ± 11.5 weeks for autograft patients (P < .01). Clinical success at 52 weeks was achieved in 57 of 63 (91%) rhPDGF-BB/ß-TCP-collagen patients and 120 of 154 (78%) autograft patients (P < .001). Safety-related outcomes were equivalent. Autograft controls had 2 bone graft harvest infections. CONCLUSIONS: Application of rhPDGF-BB/ß-TCP-collagen was a safe, effective alternative to autograft for ankle and hindfoot fusions, eliminating the pain and morbidity associated with autograft harvesting. LEVEL OF EVIDENCE: Level I, prospective randomized study.

Proximal opening wedge osteotomy with wedge-plate fixation compared with proximal chevron osteotomy for the treatment of hallux valgus: a prospective, randomized study.

BACKGROUND: Hallux valgus with an increased intermetatarsal angle is usually treated with a proximal metatarsal osteotomy. The proximal chevron osteotomy is commonly used but is technically difficult. This study compares the proximal opening wedge osteotomy of the first metatarsal with the proximal chevron osteotomy for the treatment of hallux valgus with an increased intermetatarsal angle. METHODS: This prospective, randomized multicenter (three-center) study was based on the clinical outcome scores of the Short Form-36, the American Orthopaedic Foot & Ankle Society forefoot questionnaire, and the visual analog scale for pain, activity, and patient satisfaction. Subjects were assessed prior to surgery and at three, six, and twelve months postoperatively. Surgeon preference was evaluated based on questionnaires and the operative times required for each procedure. RESULTS: No significant differences were found for any of the patients' clinical outcome measurements between the two procedures. The proximal opening wedge osteotomy was found to lengthen, and the proximal chevron osteotomy was found to shorten, the first metatarsal. The intermetatarsal angles improved (decreased) significantly, from 14.8° ± 3.2° to 9.1° ± 2.9 (mean and standard deviation) after a proximal opening wedge osteotomy and from 14.6° ± 3.9° to 11.3° ± 4.0° after a proximal chevron osteotomy (p < 0.05 for both). Operative time required for performing a proximal opening wedge osteotomy is similar to that required for performing a proximal chevron osteotomy (mean and standard deviation, 67.1 ± 16.5 minutes compared with 69.9 ± 18.6 minutes; p = 0.510). CONCLUSIONS: Opening wedge and proximal chevron osteotomies have comparable radiographic outcomes and comparable clinical outcomes for pain, satisfaction, and function. The proximal opening wedge osteotomy lengthens, and the proximal chevron osteotomy shortens, the first metatarsal. The proximal opening wedge osteotomy was subjectively less technically demanding and was preferred by the orthopaedic surgeons in this study. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Traumatic growth arrest of the distal tibia: a clinical and radiographic review.

BACKGROUND: Injury to the physis of the distal tibia in children can lead to subsequent growth arrest. This can result in physeal bars, leg-length discrepancies and angular deformities. METHOD: The cases of 12 children with distal tibial growth arrest due to ankle trauma were reviewed. All were treated at a tertiary care institution between 1990 and 2002. RESULTS: The average age at initial injury was 9.7 years (range 5-13 yr). Salter-Harris classifications (SH) of their injuries were SH2 in 4 children, SH3 in 1, SH4 in 6 and SH5 in 1 child. Four involved open fractures; 5 were high-energy injuries. Six of the injuries resulted in simple physeal bars, 4 caused pure angular deformities and 2 resulted in leg-length discrepancies > 2 cm. Eight of the physeal arrests were treated either with bar excision, selective epiphysiodesis or osteotomy for angular correction. CONCLUSION: This series reinforces the importance of frequent follow-up of distal tibial physeal injuries in order to detect growth arrest early, thus facilitating corrective surgery.