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Background and Objectives: Long-term outcomes of immediately postoperative rotational malreduction in the axial plane after operative treatment of supracondylar humeral fractures (SCHF) are unknown. This study aimed to investigate the long-term clinical outcomes and associated factors for immediately postoperative rotational malreduction of SCHF. Materials and methods: In this retrospective case-control study, 88 patients who underwent surgery for Gratland type III SCHF were enrolled between January 2012 and January 2020. Among them, 49 patients had immediately postoperative malrotational reduction (rotational malreduction group) and 39 patients had no rotational deformity (control group). To evaluate the associated factors for immediately postoperative rotational malreduction, demographic data, fracture patterns, physical examination signs, and preoperative radiological parameters were analyzed. To compare the clinical outcomes, operation time, range of motion of the elbow, time from operation to full range of motion, and Flynn criteria were evaluated. The Oxford elbow score was used to investigate long-term clinical outcomes for patients five years after operation. Results: The mean age was 5.7 ± 2.3 years and mean follow-up period was 15.7 ± 4.0 months. The rotational malreduction group had significantly more patients with oblique fracture pattern (p = 0.031) and Pucker sign (p = 0.016) and showed a significantly longer operative time (p = 0.029) than the control group. Although there was no significant difference in the range of elbow motion and the Flynn criteria, the Kaplan-Meier survival curve showed a longer time to recover the full range of elbow motion in the rotational malreduction group (p = 0.040). There were no significant differences in the long-term clinical outcomes assessed using the Oxford elbow score (p = 0.684). Conclusions: Oblique fracture pattern and Pucker sign may be associated with immediately postoperative rotational malreduction in the axial plane. Although patients with immediately postoperative rotational malreduction showed favorable results of long-term clinical outcomes, they required more weeks to recover the full range of elbow motion.
Subject(s)
Humeral Fractures , Range of Motion, Articular , Humans , Humeral Fractures/surgery , Humeral Fractures/physiopathology , Female , Male , Retrospective Studies , Case-Control Studies , Child , Child, Preschool , Treatment Outcome , Fracture Fixation, Internal/methods , Rotation , Postoperative ComplicationsABSTRACT
Objective: Major lower extremity amputation (LEA) such as below-knee or above-knee amputations can result in more physical disabilities and poorer socioeconomic functions than minor LEAs in diabetic foot ulcer (DFU). Therefore, identification of risk factors for major LEA and investigation of effectiveness of endovascular revascularization are critical for prevention and better prognosis of DFU patients. Methods: From January 2014 to December 2017, a total of 125 patients with DFU treated with any level of amputation were included in this study. Demographic, diabetes-related, DFU-related and -relevant laboratory information were investigated to predict major amputation. To identify risk factors for major amputation, logistic regression analysis was performed for each variable. The effectiveness of endovascular revascularization treatment was analyzed using Kaplan-Meier survival curves. Results: Major amputation was performed for 22 of 125 patients. Multivariate logistic regression analysis indicated that DM duration, peripheral arterial occlusive disease (PAOD) previous amputation, abscess, Wagner grade, CRP and albumin were significant risk factors for major amputation in DFU patients. PAOD was the most important risk factor. Major amputation-free survival rate at 5 years was 97.4% in a non-PAOD group, 58.3% in a PAOD without revascularization group, and 88.0% in a PAOD with revascularization group, showing statistically significant differences among them. Conclusion: The duration of DM, PAOD, previous amputation, abscess, Wagner grade, CRP and albumin were major risk factors for major LEA in DFU patients. The most valuable and critical finding was that revascularization in diabetic foot patients with PAOD significantly improved major amputation-free survival rates.
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Delirium is associated with greater morbidity, higher mortality, and longer periods of hospital day after hip fracture. There are number of studies on postoperative delirium after a hip fracture. However, few studies have made a distinction between preoperative and postoperative delirium. The purpose of this study is to compare risk factors and clinical outcome between preoperative and postoperative delirium in elderly patients with a hip fracture surgery. A total of 382 consecutive patients agedâ >â 65 years who underwent operation for hip fracture were enrolled. Among them, the patients diagnosed with delirium were divided into 2 groups (a preoperative delirium group and a postoperative delirium group) according to the onset time of delirium. To evaluate risk factors for preoperative and postoperative delirium, we analyzed demographic data, preoperative laboratory data, and perioperative data. To compare clinical outcomes between preoperative and postoperative delirium, we analyzed postoperative complications, KOVAL score, regression, readmission, and 2-year survival rate. Delirium was diagnosed in 150 (39.3%) patients during hospitalization. Preoperative and postoperative delirium occurred in 67 (44.6%) and 83 (55.4%) patients, respectively. Independent risk factors of preoperative delirium included age (odds ratio: 1.47, 95% confidential interval [CI]: 1.13-2.23, Pâ =â .004), stroke (odds ratio [OR]: 2.70, 95% CI: 1.11-6.01, Pâ =â .015), American Society of Anesthesiologist (OR: 1.68, 95% CI: 1.137-2.24, Pâ =â .033), and time from admission to operation (OR: 1.08, 95% CI: 1.01-1.16, Pâ =â .031). There was no significant difference in preoperative KOVAL score between the 2 groups. However, postoperative KOVAL score (5.1â ±â 2.0 vs 4.4â ±â 2.1, Pâ =â .027) and regression rate (68.7% vs 44.6%, Pâ =â .029) were significantly higher in the preoperative delirium group than in the postoperative delirium group. Moreover, the 2-year survival rate was significantly lower in the preoperative delirium group than in the postoperative delirium group (62.7% vs 78.3%, Pâ =â .046). Characteristics, risk factors, and prognosis are different for patients with preoperative delirium and postoperative delirium. Preoperative delirium patients showed different risk factors with poorer prognosis and higher mortality. Therefore, hip fracture patients with risk factors for preoperative delirium should be monitored more carefully due to their greater risk of mortality.
Subject(s)
Emergence Delirium , Hip Fractures , Aged , Humans , Retrospective Studies , Case-Control Studies , Hip Fractures/complications , Hip Fractures/surgery , Postoperative Complications/epidemiology , Risk FactorsABSTRACT
As the aging population increases, the number of patients with osteoporosis is gradually rising. Osteoporosis is a metabolic bone disease characterized by low bone mass and the microarchitectural deterioration of bone tissue, resulting in reduced bone strength and an increased risk of low-energy or fragility fractures. Thus, the use of anti-resorptive agents, such as bisphosphonates (BPs), to prevent osteoporotic fractures is growing annually. BPs are effective in reducing hip and other fractures. However, the longer a patient takes BPs, the higher the risk of an atypical femoral fracture (AFF). The exact mechanism by which long-term BP use affects the development of AFFs has not yet been clarified. However, several theories have been suggested to explain the pathogenesis of AFFs, such as suppressed bone remodeling, impaired bone healing, altered bone quality, and femoral morphology. The management of AFFs requires both medical and surgical approaches. BPs therapy should be discontinued immediately, and calcium and vitamin D levels should be evaluated and supplemented if insufficient. Teriparatide can be used for AFFs. Intramedullary nailing is the primary treatment for complete AFFs, and prophylactic femoral nailing is recommended if signs of an impending fracture are detected.
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Background: During opening-wedge, high-tibial osteotomy (OWHTO), various methods of managing the superficial medial collateral ligament (sMCL) can be performed to obtain a sufficient medial side opening. Purpose/Hypothesis: The purpose of this study was to evaluate the outcomes of distal sMCL release during OWHTO. It was hypothesized that distal sMCL release would not cause valgus instability. Study Design: Case series; Level of evidence, 4. Methods: This retrospective study included 77 patients who underwent OWHTO between January 1, 2018, and October 31, 2019, and completed serial radiological assessments including weightbearing line ratio (WBLR), medial proximal tibial angle (MPTA), coronal translation, total tibial plateau inclination (TTPI), valgus medial joint-space width (valgus-MJSW), valgus joint-line convergence angle (valgus-JLCA), varus lateral joint-space width (varus-LJSW), and varus joint-line convergence angle (varus-JLCA) on standing whole-leg and varus-valgus stress radiographs. Subgroup analysis of pre- to postoperative changes in radiologic parameters was performed according to TTPI (group 1: <25th percentile, group 2: 25th-75th percentile, group 3: >75th percentile) and Ahlbäck osteoarthritis classification (group 1: Ahlbäck grade 1, group 2: Ahlbäck grades 2 and 3). Results: The mean time to final follow-up was 34.6 ± 6.4 months. The WBLR and coronal translation did not change significantly over the follow-up period. The valgus-MJSW at 6 months postoperatively was significantly wider than that preoperatively and at 1 year postoperatively (P < .001). The varus-LJSW at 6 months postoperatively was significantly wider compared with preoperatively and 1 year postoperatively (P < .001), and the varus-LJSW at 1 year postoperatively was wider than that found preoperatively. Coronal translation was significantly more reduced for patients in TTPI group 1 versus group 3 (P = .019). There was no significant differences according to the Ahlbäck groups. All clinical outcomes improved at final follow-up compared with preoperative values (P ≤ .002). Conclusion: The study findings indicated that sMCL release did not cause valgus instability or valgus overcorrection at 1 year postoperatively, and improved clinical outcomes were seen at the final follow-up compared with preoperative status after OWHTO with sMCL release.
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Most of the fractures had been previously treated with open reduction and internal fixation. Although there are a number of fixation methods, a consensus on the treatment options has not been reached yet. Case presentation: We demonstrated the reinforced technique of tension band wiring and its surgical outcomes in the tibial tuberosity fracture of a 14-year-old male basketball player. For the modified technique, the wire was inserted between the patellar tendon and tibial tuberosity (insertion site of patellar tendon) and passed distally through the 2-mm-sized predrill cortical hole. Tightening the figure of the eight loops draws the fractured fragments together and anatomically reduces under appropriate compression. This technique can achieve the reduction and fixation of the fracture simultaneously. We confirmed the fixation stability with a range of knee joint motions. The patient was able to return back to the pre-injury level of sports activity at postoperative 2 months. Clinical discussion: The original technique of tension band wiring utilized the Kirschner wire to make a figure-of-eight loop. However, we used the patellar tendon and its insertion site of the tibial tuberosity for making a figure-of-eight loop. Moreover, the reduction and fixation of fracture were achieved simultaneously by tightening the tension band wire. This reinforced technique was firm enough for postoperative rehabilitation. Conclusion: The most certain advantage of this technique was to be able to reduce anatomically and fixate firmly with appropriate compression simultaneously. We recommend open reduction internal fixation with the reinforced technique of tension band wiring for displaced tibial tuberosity fracture in adolescent athletes.
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This study aimed to assess the safety and effectiveness of the highly cross-linked hyaluronic acid-LBSA0103-in patients with knee osteoarthritis (OA) as per the prescribing information (PI) in South Korea. A total of 3,140 subjects aged ≥19 years were enrolled in this post-marketing surveillance (PMS) study from 2013 to 2019. The subjects received one or two injections of LBSA0103. The median duration of follow-up was 308 days. Adverse events (AEs), adverse drug reactions (ADRs), and serious AEs (SAEs) were monitored. Effectiveness was evaluated based on an index of effectiveness in accordance with the guidelines established by the Ministry of Food and Drug Safety and using a 100-mm visual analog scale (VAS) for weight-bearing pain. Overall, 250 subjects (7.96%) experienced 292 AEs and of these, unexpected AEs occurred in 114 subjects (3.63% [95% CI: 3.00-4.35]). Injection site pain was the most frequent AE reported by 81 subjects (2.58% [95% confidence intervals (CI): 2.05-3.20]). One hundred subjects experienced 108 ADRs (3.18% [95% CI: 2.60, 3.86]) and 15 unexpected ADRs were experienced by 13 subjects (0.41% [95% CI: 0.22-0.71]). Seventeen subjects experienced 22 SAEs (0.54% [95% CI: 0.32-0.87]) during the entire PMS period, and all were considered "unlikely" related to the study drug. Most AEs were mild in terms of severity and resolved during the study period. LBSA0103 was also effective in relieving symptomatic pain in knee OA patients. The condition in more than 80% of the subjects was considered to be improved when assessed by the investigators. LBSA0103 resulted in a significant reduction in the mean VAS score at 12 weeks after the first and second injections (24.79 (± 20.55) mm and 17.63 (±12.31) mm, respectively; p<0.0001). In conclusion, LBSA0103, used for the treatment of knee OA in a real-world setting, was well tolerated, with an acceptable safety profile and consistent therapeutic effect.
Subject(s)
Hyaluronic Acid , Osteoarthritis, Knee , Humans , Hyaluronic Acid/adverse effects , Injections, Intra-Articular , Osteoarthritis, Knee/therapy , Republic of Korea/epidemiology , Pain/drug therapy , Pain/chemically induced , Product Surveillance, Postmarketing , Treatment OutcomeABSTRACT
BACKGROUND: Total knee arthroplasty (TKA) and high tibial osteotomy (HTO) are different procedures on the continuous spectrum of osteoarthritic knee treatments. TKA aims for neutral alignment and HTO aims for slight valgus. METHODS: 2:2:2:1 propensity score matching yielded 100, 100, 100, and 50 patients with unilateral TKA, bilateral TKA, unilateral HTO, and bilateral HTO, respectively. Radiological evaluations of pelvis, knee, ankle, and hindfoot were performed. The important factors affecting the alignment change of the adjacent joints were identified, and subgroup analyses were performed using the identified parameters. The clinical outcomes were also compared. RESULTS: The coronal alignments of the adjacent joints were corrected to the neutral position after TKA and HTO. The tibiotalar tilt angle (TTTA) was a common factor that affected changes in the ankle and hindfoot alignment. Patients with larger preoperative TTTA showed larger changes in TTTA in both TKA and HTO groups (P < 0.001). Patients with larger preoperative hindfoot alignment angle (HAA) showed larger changes in tibial plafond inclination, talar inclination, and HAA in both TKA and HTO groups (P < 0.001). TKA groups showed negative pelvic tilt values in the horizontal plane, and HTO groups showed a larger weight-bearing line ratio. CONCLUSION: Even more severe deformities including adjacent joints were observed in TKA patients, both TKA and HTO patients showed improved alignment of the adjacent joints. However, HTO patients showed closer normal alignment than patients who underwent TKA. The preoperative TTTA and HAA were important factors for restoration of ankle and hindfoot alignment after knee surgery.
Subject(s)
Arthroplasty, Replacement, Knee , Osteoarthritis, Knee , Humans , Ankle/surgery , Osteoarthritis, Knee/diagnostic imaging , Osteoarthritis, Knee/surgery , Lower Extremity , Knee Joint/diagnostic imaging , Knee Joint/surgery , Tibia/diagnostic imaging , Tibia/surgery , Osteotomy/methodsABSTRACT
BACKGROUND: Length of stay and functional outcomes after total knee arthroplasty (TKA) are related to the timing and intensity of post-operative rehabilitation. OBJECTIVE: To determine the effectiveness of early and high-intensity rehabilitation after simultaneous bilateral TKA. METHODS: Prospective cohort data of 156 patients (11 men and 145 women; average age 72.0 ± 5.6 years) who underwent simultaneous bilateral primary TKA were analyzed. The intervention group (n= 82) underwent a high-intensity rehabilitation (phase II) after early postoperative standard rehabilitation (phase I) between June 2019 and May 2021. The control group (n= 74) underwent a lower-intensity rehabilitation (phase II) after phase I rehabilitation between July 2017 and May 2019. The timed up-and-go (TUG) test, timed stair climbing test (SCT), 6-minute walk test, isometric knee extensor and flexor strength of both knees, knee flexion and extension range of motion, Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) for pain, stiffness, and functional levels, and the EuroQol five-dimension questionnaire were assessed preoperatively and 6 weeks after TKA. RESULTS: The average length of hospital stay was shortened by 5.7 days (p< 0.001). Phase II rehabilitation started earlier in the intervention group than in the control group (7.7 ± 1.3 vs 13.5 ± 2.0, p< 0.001). Compared with the control group, the intervention group showed significant improvements in the measures of mobility (WOMAC-function and SCT) and strength (isometric strength of both knee extensors and flexors) 6 weeks after TKA by statistically controlling for age and preoperative functional status. CONCLUSION: This study demonstrated that early and high-intensity rehabilitation could achieve functional improvement and shorten the length of hospital stay.
Subject(s)
Arthroplasty, Replacement, Knee , Osteoarthritis, Knee , Male , Humans , Female , Aged , Arthroplasty, Replacement, Knee/rehabilitation , Osteoarthritis, Knee/surgery , Prospective Studies , Length of Stay , Knee Joint , Range of Motion, Articular , Treatment OutcomeABSTRACT
Background: Corrective osteotomy around the knee is based on deformity profiles of the femoral and tibial sides. Opening-wedge high tibial osteotomy (OWHTO) can be favored if the outcomes are not different, even if there is a certain degree of abnormal parameters after correction. Purpose/Hypothesis: The purpose of this study was to identify the factors associated with unfavorable radiological outcomes after OWHTO for varus knees. Our hypothesis was that there would be an optimal situation in which double-level osteotomy (DLO) has advantages over isolated OWHTO and an optimal cutoff value of structural parameters for which DLO should be considered in patients with severe varus knees. Study Design: Case-control study; Level of evidence, 3. Methods: The radiological and clinical outcomes of 337 patients who underwent OWHTO were retrospectively evaluated. A subgroup analysis was performed according to the weightbearing line ratio (WBLR) (group 1: <25th percentile; group 2: 25th-75th percentile; and group 3: >75th percentile) and factors associated with unfavorable radiological outcomes. For the assessment of cutoff values of the parameters favoring DLO, unfavorable radiological outcomes were categorized as follows: (1) medial proximal tibial angle (MPTA) >95°, (2) joint-line convergence angle (JLCA) >4° (insufficient medial release), (3) JLCA <0° (medial instability), (4) recurrence of a varus deformity, and (5) lateral hinge fracture. Results: The mean follow-up period was 66.2 ± 19.1 months. A low preoperative WBLR was related to a larger preoperative to postoperative change (Δ) in the WBLR, a larger reduction in coronal translation, a larger ΔMPTA, a wide preoperative lateral joint space, and a narrow preoperative medial joint space (P < .001, P < .001, P < .001, P = .016, and P = .003, respectively). However, only an MPTA >95° was significantly related to a low WBLR in the subgroup analysis according to unfavorable radiological outcomes (P = .038). The cutoff value of ΔWBLR causing an MPTA >95° was 46.5%, which showed a good area under the curve of 0.800, with a sensitivity of 74.4% and a specificity of 82.7%. The clinical outcomes significantly improved at the final follow-up compared with those preoperatively, with no significant differences between the WBLR groups. Conclusion: A ΔWBLR ≥46.5% led to an MPTA >95°. However, clinical outcomes were not affected. DLO should be considered if the surgeon desires a postoperative MPTA ≤95°.
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Introduction: Patellar inferior pole fractures are challenging to obtain sufficient fixation. The purpose of this retrospective, case-controlled study was to compare the clinical and radiological outcomes between tension band wiring (TBW) and our novel double-row suture anchor (SA) technique in patellar inferior pole fractures. Materials and methods: This retrospective study included patients who underwent TBW or SA fixation for patellar inferior pole fractures from 2015 to 2019. A total of 63 patients were divided into two groups according to the surgical procedure: the TBW group (n = 35) and the SA fixation group (n = 28). The visual analog scale score, range of motion of the knee, Lysholm score, Kujala patellofemoral score, and patient satisfaction score were evaluated for clinical and functional outcomes. Radiological outcomes included the time to radiological union, loss of reduction, and the Insall-Salvati (IS) ratio. Results: Significant improvements in clinical outcomes were observed in both groups with no significant differences. Bone union was achieved in all patients, and there was no significant difference in the time to radiological union and the IS ratio between the two groups. All patients in the TBW group underwent additional surgeries for implant removal. However, none of the patients in the SA group underwent implant removal or experienced skin irritation. Conclusion: Our novel double-row SA technique could provide comparable fixation strength and good clinical outcomes, with fewer complications in patellar inferior pole fractures. This novel SA technique is a satisfactory alternative treatment for patellar inferior pole fractures.
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PURPOSE: This double-blind, randomized, Phase III clinical trial was conducted to assess the efficacy and safety of the novel divinyl sulfone cross-linked hyaluronate (YYD302) compared with the 1,4-butanediol diglycidyl ether cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis. METHODS: A total of 184 patients with osteoarthritis (Kellgren-Lawrence grade I-III) were randomized to 1 of 2 study groups (YYD302 group, n = 95; Synovian group, n = 89). A single injection of YYD302 or Synovian was given to both groups, and 182 participants completed the study (YYD302 group, n = 95; Synovian group, n = 87). The primary end point was the change in weight-bearing pain (WBP) at 12 weeks after the primary single injection. Secondary end points included the Knee Injury and Osteoarthritis Outcome Score; the Western Ontario and McMaster Universities Osteoarthritis Index score; the Patient Global Assessment and Investigator Global Assessment; the range of motion, swelling, and tenderness of the target knee; OMERACT-OARSI responder rate; WBP responder rate (the proportion of patients achieving at least 20 mm or 40% decrease in WBP); and rate of rescue medicine use and its total consumption at weeks 2, 4, and 12. Based on the efficacy results at week 12, the responders were administered an additional single injection of the same study drug at week 24, and safety and efficacy were additionally assessed at week 36. FINDINGS: Mean changes of WBP at 12 weeks after the primary injection were -31.76 mm with YYD302 and -29.74 mm with Synovian, proving noninferiority of the YYD302 group to the Synovian group as the lower bound of the 95% CI (-4.3 to 8.3) was well above the predefined margin (-10 mm). At week 2, the Knee Injury and Osteoarthritis Outcome Score (total, pain, activities of daily living, and sports/recreation) and Western Ontario and McMaster Universities Osteoarthritis Index scores (total, stiffness) were significantly better in the YYD302 group than in the Synovian group. There were no significant differences between the groups in all other end points. Local overall adverse events (pain, heat, erythema, or swelling) at the injection site were observed in 48.4% of the YYD302 group and in 47.7% of the Synovian group. No serious reactions were reported. There was no statistically significant difference between the 2 groups regarding re-injected patients (YYD302 group, n = 54; Synovian group, n = 46) in any of the efficacy outcomes at week 36. IMPLICATIONS: The results of this study support that YYD302 is comparable to Synovian in terms of the efficacy and safety of the intra-articular injection treatment for osteoarthritis of the knee joint. Furthermore, YYD302 provided faster improvements in some efficacy assessments compared with Synovian. ClinicalTrials.gov identifier: NCT03561779.
Subject(s)
Osteoarthritis, Knee , Activities of Daily Living , Double-Blind Method , Fermentation , Humans , Hyaluronic Acid/therapeutic use , Injections, Intra-Articular , Osteoarthritis, Knee/drug therapy , Pain Measurement , Treatment OutcomeABSTRACT
INTRODUCTION: Adequate treatment for periprosthetic distal femur fractures is challenging because of various reasons, including severe osteoporosis and distal fragments that are too small or too distal. We have introduced a new surgical technique for dual plating of periprosthetic distal femur fractures following total knee arthroplasty (TKA) and determined the clinical and radiological outcomes of minimally invasive plate osteosynthesis (MIPO) with a dual locking compression plate (LCP). MATERIALS AND METHODS: Between January 2010 and July 2019, 18 patients [mean age, 74.8 (68-89) years; average follow-up period, 14.8 (12-43) months] underwent MIPO with distal femoral LCP laterally and proximal humeral internal locking system (PHILOS) medially for periprosthetic distal femoral fractures following TKA. The minimum follow-up was 1 year. The clinical and radiological outcomes were assessed using the modified WOMAC scores, knee range of motion, time to callus formation, time to union, and complications of malunion, nonunion, and shortening. RESULTS: The average time to union was 18.4 weeks (range, 10-51 weeks) and to callus formation was 7.8 weeks (range, 2-14 weeks). At the 1-year follow-up, the average JLETS was 37.6 (range, 24-53), average knee ROM was 110.3° (range, 80-135°), and average varus-valgus angles of the distal femur were 3.2° (range, -2.9-10.5°). No nonunion, broken plates, or implant failure occurred. Malunion occurred in three patients. CONCLUSION: MIPO with dual LCP is a reliable method for stabilizing periprosthetic distal femoral fractures following TKA, with satisfactory bone union rates and low complication rates.
Subject(s)
Arthroplasty, Replacement, Knee , Bone Plates , Femoral Fractures/surgery , Fracture Fixation, Internal/methods , Periprosthetic Fractures/surgery , Postoperative Complications/surgery , Aged , Aged, 80 and over , Female , Humans , Male , Minimally Invasive Surgical ProceduresABSTRACT
OBJECTIVE: LBSA0103 is a recently developed high-molecular-weight, cross-linked, non-animal hyaluronic acid (HA). The safety of LBSA0103 has been investigated only in a limited number of patients, therefore this prospective study was designed. This study sought to assess the safety including injection-site reactions and adverse drug reactions after a single intra-articular injection of LBSA0103 in patients with osteoarthritis (OA) of the knee joint. METHODS: This study was a multicenter, single-arm, prospective cohort study. After screening, eligible patients with OA of the knee joint (Kellgren-Lawrence grades I-III) were enrolled, received a single intra-articular HA (LBSA0103) injection, and were followed up for two weeks. Any adverse events including injection-site reactions and adverse drug reactions were evaluated by the investigators. RESULTS: A total of 1949 subjects (2976 knee joints) was enrolled, all of whom received a single intra-articular injection of LBSA0103. Injection-site reactions occurred in 5.59% of enrolled subjects (109/1949), and the most frequently reported injection-site reaction was pain (4.87%), followed by swelling (1.03%). Most of the injection-site reactions were transient and resolved within 14 days without additional treatment. The incidence of adverse drug reactions other than injection-site reactions was 0.67% (13/1949). Most adverse events were of mild severity. No serious adverse events related to the study drug were reported. CONCLUSIONS: A single intra-articular injection of LBSA0103 in patients with OA of the knee joint was safe, and no significant safety concerns were observed. As such, LBSA0103 could be safely applied as an intra-articular injection for the management of knee OA. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (identifier: NCT04369261).
Subject(s)
Hyaluronic Acid , Osteoarthritis, Knee , Cohort Studies , Humans , Hyaluronic Acid/adverse effects , Injections, Intra-Articular , Knee Joint , Osteoarthritis, Knee/drug therapy , Prospective Studies , Treatment OutcomeABSTRACT
PURPOSE: To evaluate the result of implementing an initial non-operative treatment program for an acute ACL injury and to find if the timing of initiating the non-operative treatment is significant. METHODS: This study included a prospective cohort of 85 consecutive patients with acute ACL injury who were treated according to the above strategy for the initial 3 months with 1-year follow-up. Clinical evaluations were made by Lysholm score, Tegner activity score, Lachman test (LT), pivot-shit test (PST), and the side to side difference (SSD) by KT-2000 arthrometer. The results were analyzed according to the timing of initiating the non-operative treatment. RESULTS: Initially, 84% of the patients showed LT and PST ≤ grade 1, and 16% with ≥grade 2. At 1-year follow-up, 77 patients (91%) with LT and PST ≤ grade 1 did not receive reconstruction as copers and 8 patients with LT or PST ≥ grade 2 required reconstruction (six patients received the operation and two refused). The patients with LT and PST ≤ grade 1 showed average Lysholm score 91.2, average SSD 2.5 mm, and mean Tegner score decreased from 6.9 (pre-injury) to 6.2. Patients who started the non-operative treatment within 2 weeks after injury revealed superior rates of grade 0 or 1 instability than those who commenced the treatment later than 2 weeks after injury (P = 0.043). CONCLUSIONS: Implementing a non-operative treatment with brace in acute phase of ACL injury appears to be an effective and viable option to achieve a reasonable clinical outcome. We recommend earlier initiation of the non-operative treatment to obtain a better result in patients with acute ACL injury.
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BACKGROUND: Our purpose in this study was to evaluate any deficiency of protein intake for different types of sarcopenia, including osteosarcopenia and sarcopenic obesity and to establish a cut-off value for the relationship between malnutrition, sarcopenia, and osteosarcopenia. METHODS: The cross-sectional study was performed using data from the Korea National Health and Nutrition Examination Survey. A total of 4,020 participants (men, 1,698 and women, 2,322) were analyzed in the present study. Sarcopenia is defined according to the criteria for the Asia Working Group for Sarcopenia. To evaluate the adequacy of protein intake, the value obtained by dividing the amount of protein consumed through food by the daily recommended protein amount (50 g/day) of Korean males was defined as the nutrient intake ratio. RESULTS: Total protein (P<0.001 in men, P<0.001 in women) and low dietary intake protein (P<0.001 in men, P=0.046 in women) were significantly lower in the sarcopenia group than in the normal group, and were significantly lower in the osteosarcopenia group than in the normal group for both men and women. The cut-off value of the adjusted weight of protein intake for sarcopenia was 0.58 g/kg/day in men and 0.98 g/kg/day in women. The cut-off value for adjusted weight of protein intake for osteo-sarcopenia was 0.8 g/kg/day in men and 0.5 g/kg/day in women. CONCLUSIONS: A comprehensive dietary assessment to detect nutritional deficits that predispose one to or aggravate muscle atrophy is important for establishing a treatment plan for patients with malnutrition.
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OBJECTIVE: To identify preoperative physical performance factors that predict stair-climbing ability at 1 month after total knee arthroplasty. DESIGN: Prospective cohort study. SETTING: University-based rehabilitation centre. SUBJECTS: Eighty-four patients who underwent a primary unilateral total knee arthroplasty Methods: Before and 1 month post-operation, the patients completed physical performance tests, including a stair-climbing test, a 6-minute walk test, a Timed Up-and-Go test, tests of the isometric flexor and extensor strength of the operated and non-operated knees, and instrumental gait analysis. Disease-specific physical function was measured by the Western Ontario McMaster Universities Osteoarthritis Index. RESULTS: Correlation analysis showed that postoperative stair-climbing test scores were significantly correlated with preoperative physical performance and function. Linear regression analysis showed that postoperative stair-ascent scores were correlated with preoperative Timed Up-and-Go test scores and peak torque of the extensor of the operated knee. Postoperative stair-descent scores were positively correlated with preoperative stair-descent scores and age. CONCLUSION: The results show that preoperative balance ability and quadriceps strength in the operated knee could influence postoperative stair-climbing ability at 1 month after total knee arthroplasty. These findings will be useful for developing pre- and post-operative rehabilitation strategies for improving stair-climbing ability in the early stages after total knee arthroplasty.
Subject(s)
Stair Climbing/physiology , Aged , Arthroplasty, Replacement, Knee/rehabilitation , Female , Humans , Male , Preoperative Period , Prospective StudiesABSTRACT
To investigate the effects of body weight support (BWS) and gait velocity on cardiovascular responses during walking on an antigravity treadmill early after unilateral and bilateral total knee arthroplasty (TKA).This study was a cross-sectional study design. Fifty patients (7 males and 43 females; average age, 72.0â±â5.1 years) at 4 weeks after unilateral (nâ=â25) and bilateral (nâ=â25) primary TKA were enrolled in the study. Subjects walked on an antigravity treadmill at speeds of 2.5âkm/hour and 3.5âkm/hour with 3 levels (50%, 25%, and 0%) of BWS. Cardiovascular responses were monitored by measuring oxygen consumption (VO2), heart rate (HR), systolic and diastolic blood pressure (SBP/DBP), the respiratory exchange ratio (RER), and rate pressure product (RPP). Borg rating of perceived exertion (RPE) and a visual analog scale (VAS) of knee pain were recorded immediately after each trial.There were no significant differences in cardiovascular responses between the unilateral and bilateral TKA groups. In the repeated measures Analysis of Variance, VO2 levels, HR, RPP, RPE, RER, and VAS were significantly increased in proportion to 3 levels (50%, 25%, and 0%) of BWS for unilateral and bilateral TKA groups, respectively. Meanwhile, SBP and DBP were unaffected by differences in BWS. At 3.5âkm/hour, VO2, RPE, and RER values were statistically greater than those at 2.5âkm/hour under the same BWS conditions.We found that the reduction in the metabolic demand of activity, coupled with positive pressure on the lower extremities, reduced VO2 and HR values as BWS increased.Cardiovascular responses vary according to BWS and gait velocity during antigravity treadmill walking. BWS rather than gait velocity had the greatest effect on cardiovascular responses and knee pain.
Subject(s)
Arthroplasty, Replacement, Knee/rehabilitation , Body Weight , Cardiovascular System/physiopathology , Orthotic Devices , Osteoarthritis, Knee/physiopathology , Walking Speed , Aged , Blood Pressure , Cross-Sectional Studies , Exercise Test , Female , Heart Rate , Humans , Hypogravity , Male , Osteoarthritis, Knee/surgery , Postoperative PeriodABSTRACT
OBJECTIVE: To determine post-operative physical performance factors associated with gait speed in patients surgically treated for hip fracture. METHODS: Cross-sectional data from 59 patients (16 males and 43 females; mean age, 79.2±9.1 years) who underwent hip fracture surgery were enrolled. Patients completed a 10-meter walk test (10MWT) to assess gait speed. Additional physical performance tests included the Timed Up and Go test (TUG), the Berg Balance Scale (BBS), maximum voluntary isometric contraction (MVIC) of the knee extensors and flexors on the operated and non-operated sides as well as of the hip abductors (all tested using air-resistance weight machines), and analysis of spatio-temporal gait parameters at about 6 weeks after hip surgery. RESULTS: Bivariate analyses revealed a significant positive correlation between the post-operative 10MWT and the post-operative TUG, age, swing phase duration, and gait cycle duration along with a significant negative correlation between post-operative BBS score, MVIC of the knee extensors and flexors on the operated and non-operated sides, MVIC of the hip abductors, and cadence and stance phase duration. Linear regression analyses revealed that the post-operative TUG (ß=0.85, p<0.01), gait cycle duration (ß=0.17, p=0.02), and osteoporosis (ß=-0.18, p=0.02) were associated with the post-operative 10MWT. CONCLUSION: The presence of osteoporosis, post-operative balance, and isometric muscle strength in the operated and non-operated legs were statistically associated with post-operative gait speed early after hip fracture surgery.
ABSTRACT
PURPOSE: To investigate the composition and concentration of growth factors and cytokines in platelet-rich plasma (PRP) with knee osteoarthritis and to explore the association of the concentration of growth factors and cytokines with the platelet count of PRPs. METHODS: Patients who visited outpatient clinic with symptomatic knee osteoarthritis (Kellgren-Lawrence grades 1 to 3) and had no blood dyscrasia were enrolled from October 2014 to March 2015. PRPs were obtained using a commercial system. Concentrations of growth factors and cytokines were measured with an enzyme-linked immunosorbent assay. Anabolic factors (platelet-derived growth factor [PDGF]-AA, -BB, and -AB, transforming growth factor-ß, vascular endothelial growth factor [VEGF], epidermal growth factor [EGF], basic fibroblast growth factor [bFGF], and insulin-like growth factor 1), catabolic factors (interleukin [IL]-1ß and matrix metalloproteinase 13), and catabolic blockers (IL-1 receptor antagonist) were included. The degree of variation was determined by coefficient of variation (CoV). RESULTS: 105 patients were included. Growth factors and cytokines showed wide variation. bFGF showed the highest variation (CoV 78.45), and transforming growth factor-ß1 showed the lowest variation (CoV 5.30). Platelet count in PRP showed a positive correlation with PDGF-BB and -AB, and VEGF (r = 0.270, P = .005; r = 0.231, P = .018; and r = 0.200, P = .041, respectively) and was negatively correlated with IL-1ß (r = -0.220, P = .025). CONCLUSION: Growth factors and cytokines in PRPs obtained from patients with knee osteoarthritis show a wide variation; the highest variation was shown in bFGF. Platelet counts associated positively with PDGF-AB and -BB and VEGF and negatively with IL-1ß. CLINICAL RELEVANCE: This information leads to the concept that variation and association of specific factors needs to be taken into consideration for future investigations of PRPs in clinical application in patients with knee osteoarthritis.