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Objective@#To compare the predicted and actual maximal heart rate (HRmax) values in the cardiopulmonary exercise test (CPET). @*Methods@#We retrospectively investigated 1,060 patients who underwent a CPET between January 2016 and April 2020 at our institution’s cardiopulmonary rehabilitation center. The following patients were included: those aged >20 years, those tested with a treadmill, and those who underwent symptom-limited maximum exercise testing— reaching ≥85% of the predicted HRmax (62% if taking beta-blockers) and highest respiratory exchange ratio ≥1.1. Ultimately, 827 patients were included in this study. Data on diagnosis, history of taking beta-blockers, age, body mass index (BMI), and CPET parameters were collected. Subgroup analysis was performed according to age, betablockers, BMI (low <18.5 kg/m2, normal, and high ≥25 kg/m2), and risk classification. @*Results@#There was a significant difference between the actual HRmax and the predicted value (p<0.001). Betablocker administration resulted in a significant difference in the actual HRmax (p<0.001). There were significant differences in the moderate-to-high-risk and low-risk groups and the normal BMI and high BMI groups (p<0.001). There was no significant difference between the elderly and younger groups. We suggest new formulae for HRmax of cardiopulmonary patients: estimated HRmax=183-0.76×age (the beta-blocker group) and etimated HRmax=210-0.91×age (the non-beta-blocker group). @*Conclusion@#Age-predicted HRmax was significantly different from the actual HRmax of patients with cardiopulmonary disease, especially in the beta-blocker group. For participants with high BMI and moderate-tosevere risk, the actual HRmax was significantly lower than the predicted HRmax.
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Background and Objectives@#Voice therapy (VT) is considered to be the gold standard of treatment of vocal fold nodule in children. This study was designed to analyze the success rate of pediatric VT and investigate the predictive factors for good response of periatic VT for vocal fold nodule.Materials and Method This was a retrospective cohort study of 23 patients under 18 years old who were diagnosed with vocal fold nodule and received pediatric VT. We divided the patients into responding and non-responding groups. We analyzed clinical and voice parameters related to the voice results. @*Results@#Twelve patients showed improved findings after VT. By univariate analysis, female patients (85.7%) and adolescence children (100%) showed a good response to VT. In multivariate analysis, female sex (p<0.05) and adolescence children (p<0.05) were significantly related to a successful voice response. Proton pump inhibitor or antihistamine, mucolytics treatment and pre-VT voice parameters did not significantly influence voice outcomes. @*Conclusion@#Pediatric VT is more effective in female and adolescence children.
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Objective@#To confirm the safety of Intra-articular (IA) injection on the ipsilateral adhesive capsulitis (AC) after breast cancer surgery. @*Methods@#Between January 2017 and May 2020, we retrospectively studied 29 patients after breast cancer surgery who underwent IA injection in the glenohumeral joint for AC in aseptic procedure. @*Results@#There were no side effects or complications such as lymphedema or cellulitis in the patients. There was a significant improvement in pain score and range of motion (ROM) at the 1st, 3rd, and 6th months visits compared to the baseline (p<0.05). The presence or absence of axillary lymph node dissection and radiation therapy had no significant difference in improvement of ROM. But, in rotator cuff syndrome (RCS) group, there was a significant difference in improvement of shoulder IR in patients without RCS. @*Conclusion@#IA Injection on the ipsilateral AC after breast cancer surgery was safe and even effective to improve pain and shoulder ROM. Ipsilateral IA injection can be a good treatment for breast cancer surgery patients suffering from AC.
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Background@#The purpose of this study was to compare the histologic outcomes of rotator cuff (RC) repair with demineralized bone matrix (DBM) augmentation and those without DBM augmentation and to evaluate the role of DBM for tendon-to-bone (TB) healing in a rabbit model. @*Methods@#Twenty-six adult male New Zealand white rabbits were randomly allocated to the control group (n = 13) or the DBM group (n = 13). Repair was performed 8 weeks after complete transection of the right supraspinatus tendon of all rabbits. In the control group, RC repair was achieved by a standard transosseous technique. In the DBM group, RC repair was achieved using the same technique, and DBM was interposed between the cuff and bone. After 8 weeks, the RC tendon entheses from all rabbits were processed for gross and histologic examination. @*Results@#On gross TB healing, 2 of 11 specimens in the control group were unhealed and no specimen was grossly unhealed in the DBM group (p = 0.421). In the control group, the tendon midsubstance was disorganized with randomly and loosely arranged collagen fibers and rounded fibroblastic nuclei. The TB interface was predominantly fibrous with small regions of fibrocartilage, especially mineralized fibrocartilage. In the DBM group, the tendon midsubstance appeared normal and comprised densely arranged collagen fibers, with orientated crimped collagen fibers running in the longitudinal direction of the tendon. These fibers were interspersed with elongated fibroblast nuclei. The TB interface consisted of organized collagen fibers with large quantities of fibrocartilage and mineralized fibrocartilage. @*Conclusions@#The use of DBM for TB interface healing in rabbit experiments showed good results in gross and histologic analysis. However, it is difficult to draw a solid conclusion because the sample size is small. Further evaluation in the in vivo setting is necessary to determine clinical recommendations.
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Objectives@#. Head and neck squamous cell carcinomas (HNSCs) are frequently diagnosed at the locoregional advanced stage (stage IVa), but controversy remains regarding whether stage IVa HSNCs should be treated with upfront surgery or definitive chemoradiation therapy (CRT). The purpose of this study was to compare overall survival (OS) and disease-free survival (DFS) in patients with stage IVa HNSC treated primarily by surgery with curative intent with/without (neo)adjuvant treatment (surgery group) versus those treated primarily with CRT (CRT group). @*Methods@#. We reviewed data of 1,033 patients with stage IVa HNSC treated with curative intent at 17 cancer centers between 2010 and 2016. @*Results@#. Among 1,033 patients, 765 (74.1%) received upfront surgery and 268 (25.9%) received CRT. The 5-year OS and DFS rates were 64.4% and 62.0% in the surgery group and 49.5% and 45.4% in the CRT group, respectively. In multivariate analyses, OS and DFS were better in the surgery group than in the CRT group (odds ratio [OR] for death, 0.762; 95% confidence interval [CI], 0.592–0.981; OR for recurrence, 0.628; 95% CI, 0.492–0.802). In subgroup analyses, the OS and DFS of patients with oropharyngeal cancer were better in the surgery group (OR for death, 0.548; 95% CI, 0.341–0.879; OR for recurrence, 0.598; 95% CI, 0.377–0.948). In the surgery group, patients with laryngeal cancer showed better OS (OR for death, 0.432; 95% CI, 0.211–0.882), while those with hypopharyngeal cancer DFS was improved (OR for recurrence, 0.506; 95% CI, 0.328–0.780). @*Conclusion@#. A survival benefit from surgery may be achieved even in patients with stage IVa HNSC, particularly those with oropharyngeal and laryngeal cancer. Surgery led to a reduction in the recurrence rate in patients with hypopharyngeal cancer.
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Objective@#This study aimed to establish an animal model of oral dysphagia for translational research purposes. @*Methods@#Four week old C57BL/6 mice were randomized to a surgical partial glossectomy group (horizontal resection, n=13 vs. vertical resection, n=15) and a nonsurgical group (control, n=7). The survival rate, mouse weight, amount of food, and water consumption were compared. Comparisons were made using a Kruskall Wallis test, and survival was analyzed using Kaplan-Meier method. @*Results@#Eleven of the 13 (84.6%) horizontal resection animals and 11 of the 15 (73.3%) vertical resection animals survived to the study endpoint. Compared to the non-surgical control mice, the mice that had undergone a horizontal and vertical resection had a significantly lower mean body weight (P＜0.05) during experimental day (ED) 5, with the greatest dysphagia observed in ED 2. The horizontal resection-type mice showed greater mean body weight loss and food consumption in the early stages of the experiment than the vertical resection-type mice. In contrast, the horizontal resection-type mice showed greater body weight gain and food consumption in the late stages of the experiment. @*Conclusion@#This study provides novel evidence that the proper timing for an animal model of oral dysphagia was within ED 5; severe dysphagia was observed in ED 2. The horizontal-type partial glossectomy had a better survival rate than the vertical-type model. Furthermore, the prolonged dysphagia model mimics the vertical resection-type mice.
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Background@#The purpose of this study was to compare the histologic outcomes of rotator cuff (RC) repair with demineralized bone matrix (DBM) augmentation and those without DBM augmentation and to evaluate the role of DBM for tendon-to-bone (TB) healing in a rabbit model. @*Methods@#Twenty-six adult male New Zealand white rabbits were randomly allocated to the control group (n = 13) or the DBM group (n = 13). Repair was performed 8 weeks after complete transection of the right supraspinatus tendon of all rabbits. In the control group, RC repair was achieved by a standard transosseous technique. In the DBM group, RC repair was achieved using the same technique, and DBM was interposed between the cuff and bone. After 8 weeks, the RC tendon entheses from all rabbits were processed for gross and histologic examination. @*Results@#On gross TB healing, 2 of 11 specimens in the control group were unhealed and no specimen was grossly unhealed in the DBM group (p = 0.421). In the control group, the tendon midsubstance was disorganized with randomly and loosely arranged collagen fibers and rounded fibroblastic nuclei. The TB interface was predominantly fibrous with small regions of fibrocartilage, especially mineralized fibrocartilage. In the DBM group, the tendon midsubstance appeared normal and comprised densely arranged collagen fibers, with orientated crimped collagen fibers running in the longitudinal direction of the tendon. These fibers were interspersed with elongated fibroblast nuclei. The TB interface consisted of organized collagen fibers with large quantities of fibrocartilage and mineralized fibrocartilage. @*Conclusions@#The use of DBM for TB interface healing in rabbit experiments showed good results in gross and histologic analysis. However, it is difficult to draw a solid conclusion because the sample size is small. Further evaluation in the in vivo setting is necessary to determine clinical recommendations.
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Objectives@#. Head and neck squamous cell carcinomas (HNSCs) are frequently diagnosed at the locoregional advanced stage (stage IVa), but controversy remains regarding whether stage IVa HSNCs should be treated with upfront surgery or definitive chemoradiation therapy (CRT). The purpose of this study was to compare overall survival (OS) and disease-free survival (DFS) in patients with stage IVa HNSC treated primarily by surgery with curative intent with/without (neo)adjuvant treatment (surgery group) versus those treated primarily with CRT (CRT group). @*Methods@#. We reviewed data of 1,033 patients with stage IVa HNSC treated with curative intent at 17 cancer centers between 2010 and 2016. @*Results@#. Among 1,033 patients, 765 (74.1%) received upfront surgery and 268 (25.9%) received CRT. The 5-year OS and DFS rates were 64.4% and 62.0% in the surgery group and 49.5% and 45.4% in the CRT group, respectively. In multivariate analyses, OS and DFS were better in the surgery group than in the CRT group (odds ratio [OR] for death, 0.762; 95% confidence interval [CI], 0.592–0.981; OR for recurrence, 0.628; 95% CI, 0.492–0.802). In subgroup analyses, the OS and DFS of patients with oropharyngeal cancer were better in the surgery group (OR for death, 0.548; 95% CI, 0.341–0.879; OR for recurrence, 0.598; 95% CI, 0.377–0.948). In the surgery group, patients with laryngeal cancer showed better OS (OR for death, 0.432; 95% CI, 0.211–0.882), while those with hypopharyngeal cancer DFS was improved (OR for recurrence, 0.506; 95% CI, 0.328–0.780). @*Conclusion@#. A survival benefit from surgery may be achieved even in patients with stage IVa HNSC, particularly those with oropharyngeal and laryngeal cancer. Surgery led to a reduction in the recurrence rate in patients with hypopharyngeal cancer.
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Objective@#To determine the patterns of tracheostomy cuff pressure changes with various air inflation amounts in different types of tracheostomy tubes to obtain basic data for appropriately managing longterm tracheostomy. @*Methods@#We performed tracheostomy on a 46-year-old male cadaver. Three types of tracheostomy tubes (single-cuffed, double-cuffed, and adjustable flange), divided into 8 different subtypes based on internal tube diameters and cuff diameters, were inserted into the cadaver. Air was inflated into the cuff, and starting with 1 mL air, the cuff pressure was subsequently measured using a manometer. @*Results@#For the 7.5 mm/14 mm tracheostomy tube, cuff inflation with 3 mL of air yielded a cuff pressure within the recommended range of 20–30 cmH2O. The 7.5 mm/24 mm tracheostomy tube showed adequate cuff pressure at 5 mL of air inflation. Similar values were observed for the 8.0 mm/16 mm and 8.0 mm/27 mm tubes. Double-cuffed tracheostomy cuff pressures (7.5 mm/20 mm and 8.0 mm/20 mm tubes) at 3 mL air inflation had cuff pressures of 18–20 cmH2O at both the proximal and distal sites. For the adjustable flange tracheostomy tube, cuff pressure at 6 mL of cuff air inflation was within the recommended range. Maximal cuff pressure was achieved at inflation with almost 14 mL of air, unlike other tube types. @*Conclusion@#Various types of tracheostomy tubes showed different cuff pressures after inflation. These values might aid in developing guidelines For patients who undergo tracheostomy and are discharged home without cuff pressure manometers, this standard might be helpful to develop guidelines.
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BACKGROUND@#Hepatocyte growth factor (HGF) has been shown to facilitate vocal fold (VF) wound healing. This study was undertaken to determine whether the therapeutic efficacy of HGF could be enhanced by applying it in hyaluronic acid and alginate (HA/ALG) composite hydrogels into VFs after injury in a rabbit model. @*METHODS@#HGF was loaded into HA/ALG composite hydrogel (HGF–HA/ALG) and its in vitro release profile was evaluated. In addition, HGF–HA/ALG was injected into the VFs of rabbits immediately after direct injury and HGF or PBS was injected in the same manner into control groups. Macroscopic features were observed by endoscopy at 3 months postinjury. Functional analyses including mucosal waves of VFs and viscoelastic properties were performed by kymography following high-speed digital imaging and rheometer. Histopathological and immunohistochemical evaluations were also conducted on VFs. @*RESULTS@#HGF release from HGF–HA/ALG was sustained for up to 3 weeks. Rabbits treated with HGF–HA/ALG showed improved mucosal vibrations and VF viscoelastic properties as compared with the PBS and HGF controls.Histopathological staining revealed HGF–HA/ALG treated VFs showed less fibrosis than PBS and HGF controls, and immunohistochemical analysis demonstrated amounts of type I collagen and fibronectin were lower in HGF–HA/ALG treated animals than in PBS and HGF controls at 3 months post-injury. @*CONCLUSION@#HGF containing HA/ALG hydrogel enhanced healing in our rabbit model of VF injury.
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BACKGROUND@#Hepatocyte growth factor (HGF) has been shown to facilitate vocal fold (VF) wound healing. This study was undertaken to determine whether the therapeutic efficacy of HGF could be enhanced by applying it in hyaluronic acid and alginate (HA/ALG) composite hydrogels into VFs after injury in a rabbit model. @*METHODS@#HGF was loaded into HA/ALG composite hydrogel (HGF–HA/ALG) and its in vitro release profile was evaluated. In addition, HGF–HA/ALG was injected into the VFs of rabbits immediately after direct injury and HGF or PBS was injected in the same manner into control groups. Macroscopic features were observed by endoscopy at 3 months postinjury. Functional analyses including mucosal waves of VFs and viscoelastic properties were performed by kymography following high-speed digital imaging and rheometer. Histopathological and immunohistochemical evaluations were also conducted on VFs. @*RESULTS@#HGF release from HGF–HA/ALG was sustained for up to 3 weeks. Rabbits treated with HGF–HA/ALG showed improved mucosal vibrations and VF viscoelastic properties as compared with the PBS and HGF controls.Histopathological staining revealed HGF–HA/ALG treated VFs showed less fibrosis than PBS and HGF controls, and immunohistochemical analysis demonstrated amounts of type I collagen and fibronectin were lower in HGF–HA/ALG treated animals than in PBS and HGF controls at 3 months post-injury. @*CONCLUSION@#HGF containing HA/ALG hydrogel enhanced healing in our rabbit model of VF injury.
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Background and Objectives@#Sjögren’s syndrome (SS) is an autoimmune inflammatory disorder of exocrine glands characterized by dry mouth and eye. Recently, ultrasonography has become a valuable tool for the assessment of salivary gland involvement in SS although studies on the usefulness of salivary gland CT is rare. In this regard, we evaluated the diagnostic accuracy of parotid gland CT for SS.Subjects and Method A total of 91 patients with sicca symptoms took a parotid CT, a serology test, an ophthalmologic examination and a minor salivary gland biopsy. At the end, as a standard, we diagnosed the primary SS according to the new 2016 American College of Rheumatology/ European League Against Rheumatism classification criteria. The diagnostic value of parotid CT was compared by the McNemar test. @*Results@#Of the total of 91 patients with parotid CT, 37 (40.7%) patients met the SS classification criteria. On the parotid CT, heterogeneity of the parotid gland has the sensitivity of 74.1%, specificity of 70.3%, and accuracy of 71.4%. The abnormal fat tissue deposition showed the sensitivity of 74.1%, specificity of 81.3%, and accuracy of 79.1%. Diffuse calcification was seen in 1/91 SS patients (sensitivity 3.7%, specificity 100%, accuracy 71.4%). @*Conclusion@#Parotid CT is helpful for the diagnosis of SS. The presence of heterogeneity and fat tissue deposition are highly sensitive for the accuracy of SS. Diffuse calcification in bilateral parotid glands is highly specific for SS.
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Total knee arthroplasty is performed widely in degenerative arthritis of the knee joint, and the frequency of use is increasing. Efforts should be made to achieve functional recovery, such as returning to daily life, and the recovery of strength and range of motion after surgery. The procedure should be approached from a range of perspectives, such as patient factors, surgical technique and rehabilitation. The patient’s age, degree of obesity, sex, and strength of the quadriceps muscle can affect the functional recovery after surgery. In addition, the patient’s mental state, such as expectation value and satisfaction, can also have an effect. For functional recovery, patient education, pain control, and strengthening of the quadriceps muscle can be performed prior to surgery. Postoperative physiotherapy, such as icing and compression, transcutaneous electrical nerve stimulation therapy, neuromuscular electrical stimulation therapy, low frequency low intensity magnetic field therapy, strengthening of quadriceps muscle, and range of motion exercise can also be applied. In recent years, hydrotherapy, which restores the strength and balance of the leg, is being performed increasingly. These treatments are not only performed shortly after surgery, but are also performed continuously. In addition, the surgeon should apply it appropriately considering the patient’s condition, compliance, and social and psychological conditions.
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PURPOSE: To compare the clinical outcomes of arthroscopic partial and subtotal resection of the impinged infrapatellar fat pad (IFP). MATERIALS AND METHODS: This study enrolled 55 patients with IFP impingement who underwent partial resection (n=29, P group) or subtotal resection (n=26, S group). Clinical outcomes at least 2 years postoperatively were evaluated using a visual analog scale (VAS) for pain, the International Knee Documentation Committee (IKDC) 2000 subjective knee score, and the Lysholm score. RESULTS: In the P group, the preoperative mean VAS, IKDC 2000, and Lysholm scores were 5.6±0.61, 47.5±7.41, and 42.5±7.17, respectively, which improved significantly to 1.4±0.63, 70.9±6.15, and 82.2±7.61, respectively (all, p≤0.001). In the S group, the preoperative mean VAS, IKDC 2000, and Lysholm scores were 5.7±0.43, 47.7±9.09, and 45.2±4.18, respectively, which improved significantly to 1.8±0.77, 71.9±9.33, and 82.3±6.01, respectively (all, p≤0.001). There were no significant differences in any outcome measure between the groups at the final follow-up. CONCLUSIONS: Arthroscopic resection of the impinged IFP between the patella and femoral trochlea resulted in favorable clinical outcomes regardless of whether the resection was partial or subtotal. Thus, partial resection can be an appropriate treatment option, considering partial resection was as effective as subtotal resection and retained more of the IFP.
Subject(s)
Humans , Adipose Tissue , Arthroscopy , Follow-Up Studies , Knee , Outcome Assessment, Health Care , Patella , Visual Analog ScaleABSTRACT
PURPOSE: To identify the femoral footprint of the anterior cruciate ligament (ACL) in Koreans. MATERIALS AND METHODS: Eighteen embalmed cadaveric knees (mean age, 70 years) were examined. First, the shape of the ACL was determined macroscopically. After the ACL femoral footprint was defined, the ACL was cut from the femur and a Kirschner wire was inserted into the center of the ACL, and the position was verified with a C-arm. The position was quantified on the C-arm field using the quadrant method. The length and width of the ACL were measured. RESULTS: Macroscopically, the ACL is a flat single bundle with an average length of 34 mm and an average width of 9 mm. On average, the center of the ACL insertion site measured with the quadrant method was positioned at 29.5%±2.8% in an anterior direction (from posterior), and at 38.5%±3.2% in a distal direction (from Blumensaat's line). The anterior and posterior margins of the ACL femoral footprint were the resident's ridge and the cartilage margin of the lateral femoral condyle, respectively. CONCLUSIONS: The center of the ACL femoral footprint is positioned more anteriorly and distally than the positions identified in previous studies.
Subject(s)
Anterior Cruciate Ligament Reconstruction , Anterior Cruciate Ligament , Cadaver , Cartilage , Femur , Knee , MethodsABSTRACT
BACKGROUND: To evaluate the clinical outcomes and associated repair integrity in patients treated with arthroscopic repair for a transtendinous rotator cuff tear followed by resection of the remnant rotator cuff tendon. METHODS: Between July 2007 and July 2011, we retrospectively reviewed patients who were treated for transtendinous full-thickness tears in the tendinous portion of the rotator cuff by arthroscopic repair. Clinical outcomes were evaluated using the American Shoulder and Elbow Surgeons (ASES) score, the Shoulder Rating Scale of the University of California at Los Angeles (UCLA), the Constant-Murley score, a visual analogue scale (VAS) pain score, and range of motion (ROM). The repair integrity was determined by magnetic resonance imaging or ultrasonography. RESULTS: There were 19 shoulders with transtendinous full-thickness tears in the tendinous portion of the rotator cuff. The ASES, UCLA, Constant-Murley, and VAS pain scores showed significant improvements in function and symptoms (all p<0.001). The active ROM for forward flexion and abduction was also significantly improved (p=0.002 and p<0.001, respectively). The postoperative radiological examination showed cuff integrity without a re-tear in 68.4% of patients. However, the UCLA, ASES, and Constant-Murley scores were not significantly different between healed and re-torn group (p=0.530, p=0.885, and p=0.262, respectively). CONCLUSIONS: Although repair of transtendinous rotator cuff tears followed by resection of the remnant rotator cuff tendon in the footprint has a relatively high re-tear rate, no significant difference was observed in the short-term clinical results between the re-tear and healed groups.
Subject(s)
Humans , Arthroscopy , California , Elbow , Follow-Up Studies , Magnetic Resonance Imaging , Range of Motion, Articular , Retrospective Studies , Rotator Cuff , Shoulder , Surgeons , Tears , Tendons , UltrasonographyABSTRACT
BACKGROUND: To evaluate the clinical outcomes and associated repair integrity in patients treated with arthroscopic repair for a transtendinous rotator cuff tear followed by resection of the remnant rotator cuff tendon. METHODS: Between July 2007 and July 2011, we retrospectively reviewed patients who were treated for transtendinous full-thickness tears in the tendinous portion of the rotator cuff by arthroscopic repair. Clinical outcomes were evaluated using the American Shoulder and Elbow Surgeons (ASES) score, the Shoulder Rating Scale of the University of California at Los Angeles (UCLA), the Constant-Murley score, a visual analogue scale (VAS) pain score, and range of motion (ROM). The repair integrity was determined by magnetic resonance imaging or ultrasonography. RESULTS: There were 19 shoulders with transtendinous full-thickness tears in the tendinous portion of the rotator cuff. The ASES, UCLA, Constant-Murley, and VAS pain scores showed significant improvements in function and symptoms (all p<0.001). The active ROM for forward flexion and abduction was also significantly improved (p=0.002 and p<0.001, respectively). The postoperative radiological examination showed cuff integrity without a re-tear in 68.4% of patients. However, the UCLA, ASES, and Constant-Murley scores were not significantly different between healed and re-torn group (p=0.530, p=0.885, and p=0.262, respectively). CONCLUSIONS: Although repair of transtendinous rotator cuff tears followed by resection of the remnant rotator cuff tendon in the footprint has a relatively high re-tear rate, no significant difference was observed in the short-term clinical results between the re-tear and healed groups.
Subject(s)
Humans , Arthroscopy , California , Elbow , Follow-Up Studies , Magnetic Resonance Imaging , Range of Motion, Articular , Retrospective Studies , Rotator Cuff , Shoulder , Surgeons , Tears , Tendons , UltrasonographyABSTRACT
BACKGROUND: The aim of this study was to evaluate the safety and analgesic efficacy of polmacoxib 2 mg versus placebo in a superiority comparison or versus celecoxib 200 mg in a noninferiority comparison in patients with osteoarthritis (OA). METHODS: This study was a 6-week, phase III, randomized, double-blind, and parallel-group trial followed by an 18-week, single arm, open-label extension. Of the 441 patients with knee or hip OA screened, 362 were randomized; 324 completed 6 weeks of treatment and 220 completed the extension. Patients were randomized to receive oral polmacoxib 2 mg (n = 146), celecoxib 200 mg (n = 145), or placebo (n = 71) once daily for 6 weeks. During the extension, all participants received open-label polmacoxib 2 mg. The primary endpoint was the change in Western Ontario and McMaster Universities (WOMAC)-pain subscale score from baseline to week 6. Secondary endpoints included WOMAC-OA Index, OA subscales (pain, stiffness, and physical function) and Physician's and Subject's Global Assessments at weeks 3 and 6. Other outcome measures included adverse events (AEs), laboratory tests, vital signs, electrocardiograms, and physical examinations. RESULTS: After 6 weeks, the polmacoxib-placebo treatment difference was −2.5 (95% confidence interval [CI], −4.4 to −0.6; p = 0.011) and the polmacoxib-celecoxib treatment difference was 0.6 (CI, −0.9 to 2.2; p = 0.425). According to Physician's Global Assessments, more subjects were “much improved” at week 3 with polmacoxib than with celecoxib or placebo. Gastrointestinal and general disorder AEs occurred with a greater frequency with polmacoxib or celecoxib than with placebo. CONCLUSIONS: Polmacoxib 2 mg was relatively well tolerated and demonstrated efficacy superior to placebo and noninferior to celecoxib after 6 weeks of treatment in patients with OA. The results obtained during the 18-week trial extension with polmacoxib 2 mg were consistent with those observed during the 6-week treatment period, indicating that polmacoxib can be considered safe for long-term use based on this relatively small scale of study in a Korean population. More importantly, the results of this study showed that polmacoxib has the potential to be used as a pain relief drug with reduced gastrointestinal side effects compared to traditional nonsteroidal anti-inflammatory drugs for OA.
Subject(s)
Humans , Arm , Celecoxib , Electrocardiography , Hip , Knee , Ontario , Osteoarthritis , Outcome Assessment, Health Care , Physical Examination , Vital SignsABSTRACT
Femur intramedullary nailing can be one of the most predictable procedures in orthopedic traumatology. The advantage of this method is that the fracture site does not have to be widely exposed for reduction, which can minimize soft tissue damage. For this reason, the incidence of complications related to hematoma has been rare. We experienced only one case of sciatic nerve palsy due to hematoma after intramedullary nailing; the patient was receiving an anticoagulant therapy. Therefore, we report this case with literature review.