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  • 1
    In: Foot & Ankle International, SAGE Publications, Vol. 32, No. 4 ( 2011-04), p. 344-354
    Abstract: The increased morbidity and surgical time associated with harvesting autologous bone graft (ABG) have encouraged surgeons to develop synthetic orthobiologic alternatives. The recombinant form of platelet-derived growth factor (rhPDGF-BB), an angiogenic, mitogenic, and chemotactic cytokine, has been shown to significantly enhance bone formation in human periodontal osseous defects when combined with a tricalcium phosphate carrier (β-TCP). The purpose of this prospective, controlled, randomized, multi-center feasibility clinical trial was to compare the safety and efficacy of this biosynthetic bone graft substitute (Augment™ Bone Graft) to ABG during ankle and hindfoot fusion. Materials and Methods: Twenty adult subjects requiring ankle or hindfoot fusion from three U.S. centers were enrolled and randomized in a 2:1 ratio to receive Augment™ or ABG, respectively. Surgical approach and fixation techniques were standardized, and minimum followup was 9 months. The primary endpoint was radiographic osseous union, evaluated by a blinded independent radiologist. Secondary endpoints included assessment of clinical success, union rate by serial computed tomography (CT) examination, time to full weightbearing, AOFAS Ankle-Hindfoot Score (AOFAS), Foot Function Index (FFI), Short Form-12 (SF-12), and Visual Analog pain assessment Scale (Pain VAS). Results: At 36 weeks, 77% (10/13) of the Augment™ and 50% (3/6) of the ABG patients were fused based on radiographic criteria. There were two nonunions in the Augment™ group (9%, 2/14). Healing rates based on 12 week CT scanning (50% osseous bridging) were 69% (9/13) in the Augment™ and 60% (3/5) in the ABG groups, respectively. All functional outcome measures (FFI, AOFAS, SF-12), as well as the VAS pain scores, improved in both groups over time. Surgical procedure times lasted an average 26 minutes longer for the ABG as compared to the Augment™ populations. There were no device related serious adverse events in this study. Conclusion: Based on the available data, the rate of radiographic union, time to full weightbearing, and outcomes scores between the Augment™ and ABG subjects appear comparable. Augment™ may represent a safe and efficacious treatment alternative to ABG during foot and ankle arthrodesis. Level of Evidence:
    Type of Medium: Online Resource
    ISSN: 1071-1007 , 1944-7876
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2011
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  • 2
    Online Resource
    Online Resource
    SAGE Publications ; 2016
    In:  Foot & Ankle Orthopaedics Vol. 1, No. 1 ( 2016-08-01), p. 2473011416S0009-
    In: Foot & Ankle Orthopaedics, SAGE Publications, Vol. 1, No. 1 ( 2016-08-01), p. 2473011416S0009-
    Abstract: Other Introduction/Purpose: The use of patient reported outcomes continues to expand beyond the scope of clinical research to involve standard of care assessments across orthopaedic practices. It is currently unclear how to interpret and apply this information in the daily care of patients. We examined the relationship between patient reported outcomes (PROMIS Physical Function, Pain Interference and Depression scores) obtained at initial visit as a predictor of outcome at a minimum of 7 month follow up. Methods: Prospective collection of all consecutive patient visits to the University of Rochester Orthopaedic foot and ankle clinic was initiated on April 2015. Data through December 2015 was classified as new or follow up and operative or non-operative based on ICD-9 and CPT codes. 17,019 patient visits were collected on 7,265 patients, of which 4,213 were new patients. PROMIS physical function, pain interference, and depression scores were assessed at initial and follow up visits. Only patients with a minimum of 7 months (mean 8.2) follow up who completed all PROMIS domains were included, resulting in 262 patients (69 operative, 193 non-operative). PROMIS scores are normalized to a US population with an average score of 50 and a standard deviation of 10. Statistical analysis using student t-tests and linear regression were performed to determine if the initial PROMIS scores were predictive of patient reported outcomes at final follow up. Results: There were no differences between operative and non-operative treatment groups in initial PROMIS scores or change in scores at follow up (p 〉 0.40). Patients with higher baseline pain were likely to experience less pain over time (r=0.63, p 〈 0.01). Similarly, patients with higher baseline depression were likely to experience decreased depression over time (r =0.52, p 〈 0.01). Patients with lower baseline physical function were likely to improve over time whereas patients with higher baseline physical function were likely to worsen over time (r=0.68, p 〈 0.01). Specifically, all patients with baseline physical function score less than 28 improved over time, while all patients with a score greater than 52 worsened (Figure 1). Conclusion: Physical function, pain, and depression trends did not vary between operative and non-operative patients at 8.2 month follow up. Patients with high initial pain and depression were likely to have improvements in pain and depression over time. Similarly, patients with low initial physical function were likely to have improved physical function. However, despite treatment, patients with above average initial physical function did not experience improvement in physical function, suggesting these patients are more challenging to treat. This information demonstrates that baseline patient reported outcomes are predictive of improvement in outcomes over time, and could assist in the treatment decision process.
    Type of Medium: Online Resource
    ISSN: 2473-0114 , 2473-0114
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
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  • 3
    In: Clinical Biomechanics, Elsevier BV, Vol. 61 ( 2019-01), p. 79-83
    Type of Medium: Online Resource
    ISSN: 0268-0033
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
    detail.hit.zdb_id: 2004518-9
    SSG: 31
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  • 4
    In: Clinical Biomechanics, Elsevier BV, Vol. 69 ( 2019-10), p. 156-163
    Type of Medium: Online Resource
    ISSN: 0268-0033
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
    detail.hit.zdb_id: 2004518-9
    SSG: 31
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  • 5
    Online Resource
    Online Resource
    SAGE Publications ; 2016
    In:  Foot & Ankle Orthopaedics Vol. 1, No. 1 ( 2016-08-01), p. 2473011416S0008-
    In: Foot & Ankle Orthopaedics, SAGE Publications, Vol. 1, No. 1 ( 2016-08-01), p. 2473011416S0008-
    Abstract: Basic Sciences/Biologics Introduction/Purpose: Various biomechanical studies have examined pressure changes across the foot and ankle joints. However, most of these studies disrupted the capsuloligamentous complex surrounding the joint to insert pressure sensors, compromising the integrity of the natural joint structure and the accuracy of biomechanical assessments. This is the first noninvasive study to report measurement of natural joint reaction forces (JRF) across the foot and ankle while preserving all soft tissue structures. Since articular surfaces experience equal and opposing compression forces, we aimed to evaluate the distraction force needed to overcome these compression forces. Methods: Ten fresh-frozen cadavers of the lower extremity were obtained that were disarticulated at the knee joint. Steinmann pins were percutaneously placed across the distal tibia, and the center of the talus, navicular, cuboid, and calcaneus while preserving all surrounding soft tissues. A custom fixation device was utilized in conjunction with a tensile testing machine to allow distraction in line with the axis of the tibiotalar, subtalar, talonavicular (TN), and calcaneocuboid (CC) joints. Displacement was measured as distance between Steinmann pins on either side of the joint examined. Under progressive axial distraction, displacement and force were measured. Best-fit polynomials were calculated to fit the force-displacement curves. The inflection point, representing the joint reaction force (JRF) where distraction forces across the joint equal the compression forces, was calculated for each curve. Results: All force-displacement curves demonstrated an inflection point. Prior to the inflection point, relatively large increases in distraction force resulted in minimal displacement. Once the inflection point was reached, relatively small increases in distraction force resulted in large increases in displacement. Each cadaver was measured three times with high reproducibility. The mean JRF were tibiotalar 33.8 N [standard deviation (SD) 10], subtalar 18.2 N (SD 12), TN 13.3 N (SD 4), and CC 14.7 N (5.8). Conclusion: We present the first application of a reliable and noninvasive method of measuring JRF of the foot and ankle joints. In the medium or small joints, dissection of the capsule and surrounding ligaments can significantly alter joint stability and biomechanics. By preserving all the periarticular soft tissues, this experimental model will allow future investigation of biomechanical changes of pathologic states and efficacy of surgical intervention under conditions that most accurately reflect the in vivo state.
    Type of Medium: Online Resource
    ISSN: 2473-0114 , 2473-0114
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
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  • 6
    Online Resource
    Online Resource
    Journal of Orthopaedic & Sports Physical Therapy (JOSPT) ; 2014
    In:  Journal of Orthopaedic & Sports Physical Therapy Vol. 44, No. 4 ( 2014-04), p. 283-290
    In: Journal of Orthopaedic & Sports Physical Therapy, Journal of Orthopaedic & Sports Physical Therapy (JOSPT), Vol. 44, No. 4 ( 2014-04), p. 283-290
    Type of Medium: Online Resource
    ISSN: 0190-6011 , 1938-1344
    Language: English
    Publisher: Journal of Orthopaedic & Sports Physical Therapy (JOSPT)
    Publication Date: 2014
    detail.hit.zdb_id: 2113650-6
    SSG: 31
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  • 7
    In: Foot & Ankle Orthopaedics, SAGE Publications, Vol. 5, No. 4 ( 2020-10-01), p. 2473011420S0025-
    Abstract: Hindfoot Introduction/Purpose: Triple arthrodesis has historically been considered the standard of treatment for arthritis of the hindfoot with or without deformity. The complications of this surgery including non-union, malunion, nerve injury, infection and wound healing problems can occur at any of the three joints. Double arthrodesis is capable of producing a similar reduction in degrees of motion and correction of foot deformity but may also cause less patient morbidity in regard to these complications due to one less joint being incorporated into the fusion procedure. What is unknown is the patient reported outcomes, specifically physical function (PF) and pain interference (PI) between these two procedures. The purpose of this study is to evaluate the clinical outcomes for hindfoot deformity using a triple compared to a double arthrodesis. Methods: A retrospective medical record review was performed (February 2015-December 2019), of 96 identified cases, 54 had complete data over 4 months post operation for either a double (Age = 58 (11); Body Mass Index (BMI) = 34.4 (6.0); n=24) or triple arthrodesis (Age= 55 (13); BMI = 33.0 (10.0); n = 30). Patient Reported Outcome Measurement Information System (PROMIS) physical function and pain interference were assessed at last available pre-operation and last follow up time points. Medical records were reviewed for complications (yes/no). ANOVA models were used to assess differences pre to post surgery (covariates included age, BMI, and length of follow up). Chi Square analysis was used to assess proportions of patients achieving a minimal clinically important difference (34.5) and complications by group. Results: There were no differences between groups in terms of age (p = 0.51), BMI (p = 0.44), or length of follow up (triple = 540 (334) days versus double = 390 (336) days; p=0.12). There were no significant differences in PROMIS PF (pre-post change 95% CI: triple= 1.2 (-4.1 to 1.6) versus double = 0.2 (-2.5 to 2.0)). The for PROMIS PI both groups experienced lower pain (average 5.1 (1.0) with the greater decrease in pain in the triple group (Figure 1; pre-post change 95% CI: triple= 7.1 (-10.2 to -4.0) versus double = 3 (-5.5 to -0.6)). Chi square analysis showed that a greater proportion of patients undergoing a triple (triple 61.9 % versus double 33.3 %) experienced MCID improvement in PROMIS PI (X2=4.4, p=0.04). There were 4 complications in the double group, and 6 in the triple group. Conclusion: Double arthrodesis can allow for similar correction of foot deformities without the increased risk of wound complication, infection or nonunion/malunion. However, we found that patients who underwent a triple arthrodesis were more likely to have an improvement in minimally important clinical difference (MCID) in the PROMIS pain interference scores than those who underwent a double arthrodesis.
    Type of Medium: Online Resource
    ISSN: 2473-0114 , 2473-0114
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 8
    In: Foot & Ankle Orthopaedics, SAGE Publications, Vol. 7, No. 1 ( 2022-01), p. 2473011421S0038-
    Abstract: Bunion; Midfoot/Forefoot Introduction/Purpose: Hallux rigidus is a common and painful degenerative condition of the great toe limiting a patient's physical function and quality of life. The purpose of this study was to investigate pre- and postoperative physical function (PF) and pain interference (PI) levels of patients undergoing synthetic cartilage implant hemiarthroplasty (SCI) versus arthrodesis (AD) for treatment of hallux rigidus using the Patient Reported Outcome Measurement Information System (PROMIS). Methods: Pre- and postoperative PROMIS PF and PI t-scores were analyzed for patients who underwent either SCI or AD. Postoperative final PROMIS t-scores were obtained via phone survey. Linear mixed model analysis was used to assess differences in PF and PI at each follow up point. Final follow-up scores were analyzed using independent sample t-tests. Results: Total 181 (59 SCI, 122 AD) operatively managed patients were included for analysis of PROMIS scores. Final phone survey was performed at mean 33 (14-59) months postoperatively, with 101 patients (40 SCI, 61 AD) successfully contacted. Mean age of the SCI cohort was younger than the AD cohort (57.5 versus 61.5 years-old, p = 0.01). Average PF t-scores were higher in the SCI cohort compared to AD cohort at baseline (47.1 versus 43.9, respectively; p = 0.01) and at final follow up (51.4 versus 45.9, respectively; p 〈 0.01). A main effect of superior improvement in PF was detected in SCI group (+4.3) versus AD group (+2) across time intervals (p 〈 0.01). PI t-scores were similar between the two procedures across time points. Conclusion: The SCI cohort reported superior PF t-scores at all follow-up time points compared to the arthrodesis group. No differences were found for PI or complication rates between the two treatment groups during this study timeframe.
    Type of Medium: Online Resource
    ISSN: 2473-0114 , 2473-0114
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
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  • 9
    Online Resource
    Online Resource
    SAGE Publications ; 2000
    In:  Foot & Ankle International Vol. 21, No. 5 ( 2000-05), p. 392-399
    In: Foot & Ankle International, SAGE Publications, Vol. 21, No. 5 ( 2000-05), p. 392-399
    Abstract: Eighty six subtalar arthrodeses performed between 1985 and 1996 for complications associated with intra-articular calcaneal fractures were retrospectively evaluated. Patients were divided into three Groups: (I) 59 patients with calcaneal malunions (II) 13 patients with failed open reduction and internal fixation, and (III) eight patients undergoing open reductions and primary fusion for highly comminuted fractures. In each scenario, internal fixation was achieved with cancellous lag screws. Bone graft material consisted of either autogenous iliac crest graft, local graft obtained from the lateral wall exostectomy of the malunion, or freeze-dried cancellous allograft. Fusions in Groups II and III were performed in situ. Fusions in Group I were performed either in situ or utilizing a variety of reconstructive procedures depending upon the type of malunion encountered. Eighty three of the 86 fusion attempts were successful following the initial operations for a union rate of 96%. Fusion rates were similar regardless of the graft material used. Complications included four varus malunions, four cases of osteomyelitis, and two cases of reflex sympathetic dystrophy. A statistically significant shorter hospital stay was found for patients not undergoing iliac crest bone graft procedures. Eighty patients with at least two year follow up achieved a mean American Orthopaedic Foot and Ankle Society(AOFAS) ankle-hindfoot score of 75.0. Scores were similar for all three groups and for the various types of reconstructive procedures used. No correlation was found between postoperative talar declination angle and the AOFAS ankle-hindfoot score. Worker's compensation patients tended to have a poorer clinical outcome.
    Type of Medium: Online Resource
    ISSN: 1071-1007 , 1944-7876
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2000
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  • 10
    Online Resource
    Online Resource
    SAGE Publications ; 2009
    In:  Foot & Ankle International Vol. 30, No. 6 ( 2009-06), p. 530-539
    In: Foot & Ankle International, SAGE Publications, Vol. 30, No. 6 ( 2009-06), p. 530-539
    Abstract: Background: Subjects with stage II posterior tibial tendon dysfunction (PTTD) exhibit abnormal foot kinematics; however, how individual segment kinematics (hindfoot (HF) or first metatarsal (first MET) segments) influence global foot kinematics is unclear. The purpose of this study was to compare foot and ankle kinematics and sagittal plane HF and first MET segment kinematics between stage II PTTD and controls. Materials and Methods: Thirty patients with stage II PTTD and 15 healthy controls were evaluated. Kinematic data from the tibia, calcaneus, and first MET were collected during walking using three dimensional motion analysis techniques. A three-segment foot model (HF, calcaneus; first MET, first metatarsal, and tibia) was used to calculate relative angles (ankle, HF relative to tibia; midfoot, first MET relative to HF) and segment angles (HF and first MET relative to the global). A mixed effect ANOVA model was utilized to compare angles between groups for each variable. Results: Patients with PTTD showed greater ankle plantarflexion ( p = 0.02) by 6.8 degrees to 8.4 degrees prior to or at 74% of stance; greater HF eversion ( p 〈 0.01) across stance (mean difference = 4.5 degrees); and greater first MET dorsiflexion ( p 〈 0.01) across stance (mean difference = 8.8 degrees). HF and first MET segment angles revealed greater HF dorsiflexion ( p = 0.01) during early stance and greater first MET dorsiflexion ( p = 0.001) across stance. Conclusion: Abnormal HF and first MET segment kinematics separately influence both ankle and midfoot movement during walking in subjects with stage II PTTD. Clinical Relevance: These abnormal kinematics may serve as another measure of response to clinical treatment and/or guide for clinical strategies (exercise, orthotics, and surgery) seeking to improve foot kinematics.
    Type of Medium: Online Resource
    ISSN: 1071-1007 , 1944-7876
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2009
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