REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia.

INTRODUCTION: Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia. METHODS AND ANALYSIS: REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18-80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app. ETHICS AND DISSEMINATION: The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Efficacy of a Combined Periarticular and Intraosseous Multimodal Analgesic Injection Technique in Simultaneous Bilateral Total Knee Arthroplasty: A Randomized Controlled Trial.

Introduction Early postoperative pain poses a challenge for surgeons to manage after total knee arthroplasty (TKA). Various techniques have been employed to optimize pain reduction, including Periarticular Multimodal Analgesia (PMA), recognized as a safe and effective method. Our study aims to enhance PMA through a combined intraosseous injection (PMA-I) and compare it with standard PMA. Methods Forty patients undergoing simultaneous bilateral TKA surgery were enrolled. Patients were randomized to receive PMA-I on one side of the knee, while the contralateral knee received standard PMA. Pain scores, bleeding, and range of motion (ROM) were assessed in both groups. Results The PMA-I group demonstrated statistically significant lower visual analog scale (VAS) scores at all postoperative time points, except at 48 hours, where the difference was not statistically significant. Postoperative bleeding and ROM did not significantly differ between groups. Conclusion PMA-I demonstrated both statistically and clinically significant reduction in early post-TKA pain, without additional costs, providing a technique that can be used to optimize postoperative pain control in TKA.

Topical anaesthesia as an adjuvant to local anaesthetic injection in open trigger digit release: a randomized controlled trial.

We conducted a randomized controlled trial to compare pain scores and patient satisfaction between topical anaesthetic cream (5% lidocaine-prilocaine cream) versus placebo cream, applied approximately 90 minutes before local anaesthetic injection for open trigger digit release. One hundred participants were enrolled and randomly allocated into the two groups between May 2019 and February 2020. The visual analogue pain scores and satisfaction scores were measured. Most participants were female with Quinnell Grade 2-3 trigger digits. The pain scores during needle injection, local anaesthetic infiltration, the overall pain and satisfaction scores had no statistically significant differences between groups. There was no correlation between duration of topical anaesthetic drug application and pain scores. Subgroup analysis did not show significant differences in pain scores between genders. No complications were found during the study period. The topical anaesthetic drug was ineffective to use on the palmar skin during open trigger digit release surgery.Level of evidence: II.

Modified Robert Jones bandage can not reduce invisible blood loss after total knee arthroplasty: a randomized-controlled trial.

INTRODUCTION: To compare the efficacy and safety of modified Robert Jones bandage (MRJB) and non-compressive dressing (NCD) on reducing invisible blood loss (IBL) after total knee arthroplasty (TKA). MATERIALS AND METHODS: Eighty patients who underwent unilateral TKA were randomly assigned into two groups: MRJB and NCD groups. Pre- and post-operative hematocrit levels, amount of drained blood and transfused blood were measured and calculated into IBL. Pain score, amount of morphine usage, range of motion (ROM) at discharge, blood transfusion rate, and complications were also recorded and compared between both groups. RESULTS: There was no significant difference in the mean IBL between MRJB (221.2 ± 233.3 ml) and NCD groups (158.5 ± 186.7 ml) (p = 0.219). Post-operative pain score at rest and during ambulation, amount of morphine usage, ROM at discharge, blood transfusion rate, and complications were also similar between two groups. CONCLUSIONS: This study cannot determine the benefit of MRJB over NCD. The use of MRJB may not be necessary after primary TKA.

Association between leukocyte telomere length and angiogenic cytokines in knee osteoarthritis.

AIM: The aims of this study were to compare leukocyte relative telomere length (RTL) in knee osteoarthritis (OA) patients and healthy controls and to investigate associations between plasma angiogenic cytokine concentrations and leukocyte RTL. METHOD: Eighty knee OA patients and 60 age-matched controls were enrolled. Leukocyte RTL was assessed using real-time quantitative polymerase chain reaction (qPCR). Angiogenic cytokines were measured by a multiplex immunoassay. RESULTS: Leukocyte RTL in knee OA patients was significantly lower than that in healthy controls (1.1 ± 0.4 vs. 1.3 ± 0.6, P = 0.039). Plasma angiopoietin-2, follistatin, granulocyte-colony stimulating factor (G-CSF), hepatocyte growth factor (HGF), interleukin-8 (IL-8), platelet endothelial cell adhesion molecule-1 (PECAM-1), and vascular endothelial growth factor (VEGF) levels in knee OA patients were higher than those in controls (P < 0.01). Correlation analysis revealed significant negative correlations between leukocyte RTL and plasma levels of HGF (r = -0.377, P = 0.017), VEGF (r = -0.405, P = 0.009) and G-CSF (r = -0.347, P = 0.026). In contrast, plasma angiopoietin-2, follistatin, IL-8, leptin, platelet-derived growth factor-BB and PECAM-1 were not correlated with leukocyte RTL. CONCLUSION: Telomere length was shortened in knee OA patients compared to healthy controls. Plasma HGF, VEGF and G-CSF were negatively correlated with leukocyte RTL, suggesting involvement of telomere shortening and these cytokines in knee OA.

Anterior greater trochanteric muscle pedicle bone grafting: a viable graft option adjunct to hip osteotomy or fracture surgery.

INTRODUCTION: The objectives were to evaluate a technique, outcome and complications following anterior greater trochanteric with gluteus medius muscle pedicle bone graft (AMG) procedure in the treatment of adolescent and active adult hip disorders. METHODS: 20 patients (20 hips) with a mean age of 22.7 ± 15.6 (range 10.0-63.5) years who had undergone AMG and been followed up more than 12 months postoperative were retrospectively enrolled in our study. The AMG procedure was performed in conjunction with subcapital osteotomy for slipped capital femoral epiphysis in 12 and open reduction for fracture/dislocation in 8 hips. At the most recent evaluation, patient functional status was rated by the Harris Hip Score (HHS) and radiographic changes were graded according to Tönnis criteria. Complications were defined as Tönnis grade >2 or hip requiring further surgery. Univariate analysis was used to explore factors associated with complications. Spearman's rank correlation coefficient was calculated between HHS and Tönnis grading. RESULTS: At mean follow-up of 4.4 ± 2.6 (range 1.1-9.5) years, mean HHS was 87.4. Tönnis grading was rated as 0 in 10 hips, 1 in 5 hips, 2 in 2 hips, and 3 in 3 hips. Avascular necrosis of the femoral head as a complication developed in 3 hips (15%). Clinical parameters including age at surgery, duration of follow-up and diagnosis were not significantly associated with postoperative complications. A negative correlation between HHS and Tönnis grade was shown by Spearman's rank correlation (rs = -0.49, p = 0.03). CONCLUSIONS: The AMG can be safely recommended as an adjunct bone graft procedure when performing anterior open reduction of adolescent and active adult hip disorders.

Alteration of inflammatory cytokine production in primary total knee arthroplasty using antibiotic-loaded bone cement.

BACKGROUND: The aim was to compare serum levels of interleukin-6 (SIL6), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and joint fluid IL-6 (JIL-6) level between total knee arthroplasty (TKA) that used bone cement (BC group) and antibiotic-loaded bone cement (ALBC group). MATERIALS AND METHODS: Thirty-nine patients (40 TKAs) with a mean age of 69.6 years were non-randomly assigned to the BC or ALBC groups. Samples of SIL6, ESR, and CRP were collected at baseline and at 24 h, 72 h, and 4 weeks after surgery. JIL-6 levels were collected intraoperatively before joint arthrotomy, before finishing the procedure and 24 h after surgery. Postoperative mediator levels were compared with baseline levels within the same group and between groups at each time point. Knee Society Score-knee (KSSK) and Knee Society Score-function (KSSF) scores were evaluated. RESULTS: SIL-6, ESR, and CRP levels were significantly elevated at 24 and 72 h, compared to baseline. Only SIL-6 levels at 72 h in the ALBC group showed a significantly lower level than those in the BC group. JIL-6 levels were not different between groups. There were no significant differences in KSSK or KSSF scores between groups at 4 weeks and the most recent follow-up (1.4 ± 0.6 years) evaluation. No correlations were identified among SIL-6 and JIL-6 levels at 24 and 72 h, and KSSK and KSSF scores at 4 weeks and at the most recent evaluation. CONCLUSIONS: ALBC showed a favorable immunomodulatory effect and lower SIL-6 level at 72 h following TKA compared to BC, although functional benefits require further investigation. LEVEL OF EVIDENCE: OCEBM, Level 3.

Plasma and synovial fluid inflammatory cytokine profiles in primary knee osteoarthritis.

OBJECTIVE: The objective of this study is to compare inflammatory cytokine levels in primary knee osteoarthritis (OA) patients and healthy controls. METHODS: A total of 32 knee OA patients and 14 healthy controls were enrolled. A multiplex immunoassay was utilized for 10 cytokines in plasma and synovial fluid. RESULTS: Plasma IL-2, IL-4, and IL-6 concentrations were significantly greater in knee OA patients than controls. Moreover, both plasma IL-4 and IL-6 were positively correlated with the radiographic severity of knee OA. CONCLUSIONS: Plasma IL-4 and IL-6 may serve as biomarkers reflecting the severity of OA.

Effects of Cemented Hip Stem Pre-heating on Stem Push-out Strength.

OBJECTIVE: To determine the effect on ultimate push-out load and cement-stem surface shear strength of thermally manipulating the cobalt-chromium-molybdenum (CoCrMo) alloy stems of bone cement-stem constructs. METHODS: Satin-finished CoCrMo alloy stems were allocated to the following three groups with the predetermined temperatures: T24, ambient (24 °C); T37, body (37 °C); and T44, pre-heated stem (>44 °C). They were then inserted into hand-mixed high viscosity bone cement. Ultimate push-out load to failure was assessed with a servo hydraulic testing machine and the surface shear strength calculated. Data were compared among groups using the Kruskal-Wallis with Dunn's test. A P value of less than 0.05 was considered statistically significant. RESULTS: According to Kruskal-Wallis analysis, ultimate push-out load and surface shear strength differed significantly between the groups (P = 0.001). The T37 and T44 groups had higher ultimate push-out loads and surface shear strengths than the T24 group (P = 0.04 and 0.001, respectively). However, there was no statistically significant difference in these two variables between the T37 and T44 groups (P = 0.08). CONCLUSIONS: Pre-heating CoCrMo alloy stems enhance the ultimate push-out load and surface shear strength in vitro. The suggested temperature is 37 °C. This technique is recommended for hip arthroplasty procedures.

Association of plasma and synovial fluid periostin with radiographic knee osteoarthritis: Cross-sectional study.

OBJECTIVE: To investigate plasma and synovial fluid (SF) periostin of knee osteoarthritis (OA) patients and to determine the relationship between periostin levels and the radiographic severity. METHODS: A total of 110 subjects (90 knee OA patients and 20 healthy controls) were enrolled in this study. Plasma and SF periostin were examined using an enzyme-linked immunosorbent assay. OA grading was performed using the Kellgren-Lawrence classification. RESULTS: Although plasma periostin was greater in OA patients than in controls, the difference was not significant. Additionally, SF periostin was significantly higher with respect to paired plasma (P<0.001). Moreover, plasma and SF periostin demonstrated significantly positive correlation with the radiographic severity of knee OA (r=0.537, P<0.001 and r=0.427, P<0.001, respectively). Subsequent analysis revealed that there was a positive correlation between plasma and SF periostin (r=0.368, P<0.001). CONCLUSIONS: Plasma and SF periostin levels were positively correlated with the radiographic severity of knee OA.

Spontaneous acetabular periprosthetic fracture in a patient continuously having zoledronic acid.

Zoledronic acid has been used for prevention of osteolytic and osteoblastic bone metastasis. This case report illustrates an undesirable consequence from prolonged usage of zoledronic acid in bone metastasis prevention. Periprosthetic acetabular fracture in a patient treated with zoledronic acid for 7 years was reported. The clinical presentation, radiographic and pathological results were described. This is a rare complication after total hip arthroplasty which should not be ignored especially in patients who received long term bisphosphonate.

Plasma and synovial fluid sclerostin are inversely associated with radiographic severity of knee osteoarthritis.

OBJECTIVE: The purpose of this study was to analyze sclerostin in plasma and synovial fluid of knee osteoarthritis (OA) patients and to investigate the association between sclerostin levels and radiographic severity. DESIGN AND METHODS: A total of 190 subjects (95 knee OA patients and 95 healthy controls) were recruited in the present study. Sclerostin levels in plasma and synovial fluid were assessed using an enzyme-linked immunosorbent assay. OA grading was performed using the Kellgren-Lawrence classification. RESULTS: Plasma sclerostin levels were significantly lower in OA patients than in healthy controls (P=0.004). Additionally, sclerostin levels in plasma were significantly higher with respect to paired synovial fluid (P<0.001). Moreover, sclerostin levels in plasma and synovial fluid demonstrated a significant inverse correlation with the radiographic severity of knee OA (r=-0.464, P<0.001 and r=-0.592, P<0.001, respectively). Subsequent analysis revealed that there was a positive correlation between plasma and synovial sclerostin levels (r=0.657, P<0.001). CONCLUSIONS: Sclerostin was significantly lower in OA plasma samples when compared with healthy controls. Plasma and synovial fluid sclerostin levels were inversely associated with the radiographic severity of knee OA. Therefore, sclerostin may be utilized as a biochemical marker for reflecting disease severity in primary knee OA.

Accuracy of computer-assisted total knee arthroplasty related to extra-articular tibial deformities.

OBJECTIVE: To compare the accuracy of postoperative mechanical alignment in computer-assisted total knee arthroplasties (CAS-TKA) related to various degrees of extra-articular tibial deformity. METHODS: We performed CAS-TKA on 30 knee models in which extra-articular proximal tibial deformities were preset to have malalignments ranging from 30° of varus to 30° of valgus. The knees were assigned to two groups, designated Group A (knees with ≤ 15° preoperative malalignment) and Group B (knees with > 15° preoperative malalignment), and the postoperative mechanical alignment in the two groups was compared using a computer-assisted surgery (CAS) system. Resected bone pieces from the distal femurs and proximal tibias were measured with a digital Vernier caliper and the results compared with the CAS calculations to evaluate the execution accuracy of the bone resection. RESULTS: There was no outlier in either group when a ± 3° deviation from neutral mechanical alignment was set as the acceptance criterion. Interestingly, Group B showed significantly more outliers when the acceptance criterion was a deviation of ± 2° (26.67%, p = 0.0317) or ± 1° (6.67%, p = 0.0007) from neutral alignment. There was no statistical difference between the groups in terms of the execution accuracy of the bone resection. DISCUSSION: The CAS-TKA approach provided significantly less alignment accuracy in tibia with greater preoperative frontal deformity, despite there being no outliers beyond ± 3°.

Gap changes after popliteus-tendon resection in PS-TKA: a cadaveric study in Thai female knees.

Popliteus-tendon injury during total knee arthroplasty (TKA) may result in imbalanced soft-tissue tension; however, it is unclear whether complete popliteus-tendon resection is a factor which contributes to knee instability following TKA. We performed an isolated complete resection of the popliteus tendon during a standard posterior stabilised TKA (PS-TKA) in 14 normal knees of Thai female cadavers and measured gap differences in both knee flexion and extension. In addition, we measured the distance from the femoral attachment of the popliteus tendon to the femoral condyles including the distance from the most distal femoral attachment of the popliteus tendon to the distal lateral femoral condyle (DFa-DLFC), and the distance from the most posterior femoral attachment of the popliteus tendon to the posterior lateral femoral condyle (PFa-PLFC). After completion of bone cuts, static flexion and extension gaps were measured with a tension of 98 N under intact and complete tendon resection, respectively. The mean DFa-DLFC and PFa-PLFC distances were 8.9 mm (range, 6.4-10.5mm) and 11.5mm (range, 9.5-14.0mm), respectively. Of 14 cadaveric knees, 35.7% had a DFa-DLFC distance <9 mm. Flexion and extension gaps significantly increased in both medial and lateral sides after complete popliteus resection with a similar mean increased value of 1.85 mm. The clinical evaluation of gap changes after popliteus resection on knee stability should be further investigated. A routine 9-mm distal femoral bone cut may injure the popliteus tendon during TKA conducted on small knees.

Comparable clinical outcomes between glucosamine sulfate-potassium chloride and glucosamine sulfate sodium chloride in patients with mild and moderate knee osteoarthritis: a randomized, double-blind study.

BACKGROUND: Glucosamine sulfate has been recommended for treatment of knee osteoarthritis in several published guidelines. However, there are various preparations of glucosamine that may result in different pharmacokinetic and clinical outcomes. OBJECTIVES: Comparison of clinical outcomes of two different preparations of glucosamine sulfate (Sodium chloride salt and Potassium chloride salt) in patients with mild and moderate degree knee osteoarthritis. Laboratory tests to monitor drug safety were also studied. MATERIAL AND METHOD: Patients with symptomatic mild and moderate degree knee osteoarthritis were randomly assigned to receive treatment with either glucosamine sulfate with potassium salt (GS-K) 1500 mg daily or glucosamine sulfate with sodium salt (GS-Na) 1500 mg daily. Types of treatments were blinded to both patients and evaluators. Clinical assessments were done two weeks prior to initiation of treatment and then every four weeks until the sixteen week of treatment. Standing knee radiographs were taken at the initial visit. Patients with Ahlback stage 1 to 4 were included in the current study. Clinical data included range of motion, presence or absence of joint effusion, WOMAC and SF36. Laboratory studies were also done to evaluate drug safety, including BUN, creatinine, electrolytes, and liver function test. Adverse drug reactions were also recorded. RESULTS: Ninety patients with mild and moderate knee osteoarthritis (Ahlback grade 1-4) were randomized to two treatment groups, forty-five patients each. Demographic data and initial clinical assessment were similar in both groups. Both groups demonstrated improvement of WOMAC score and SF-36 at final follow-up but this did not reach statistical significance. Differences of WOMAC score and SF-36 between the two groups were not significant at any follow-up visit. Serum potassium level increased more significantly in the GS-K group but did not exceed normal value. CONCLUSION: In this short-term randomized comparison, glucosamine sulfate with potassium salt (GS-K) is as effective in pain relief and as safe as glucosamine sulfate with sodium salt (GS-Na) for treatment of mild and moderate degree knee osteoarthritis.

Outcome of six millimeters core decompression in avascular necrosis of the femoral head.

Core decompression is the accepted method of treatment of early femoral avascular necrosis (AVN). However, its result in advanced stage AVN is varied and it frequently ends up with artificial joint replacement. The three femoral heads with AVN Ficat stage 2B/3 were treated with the core decompression procedure. Menatetrenone, vitamins and minerals supplement was administered post operatively. The outcomes were evaluated by Harris hip score, the combined necrotic angle of the involved area of the femoral head and Ficat staging. At 24 months follow up, the Harris hip score was improved in all compared to that value at the pre operative period. No hips showed any sign of femoral head further collapse or changing of AVN stage. In conclusion, core decompression can be used in the treatment of advance stage AVN. Menatetrenone was given in order to help with bone mineralization during healing stage after core decompression. When combined both treatments together, the natural history of advanced stage AVN is modified and the natural hip joint is preserved.

Reliability of digital compass goniometer in knee joint range of motion measurement.

OBJECTIVE: To compare the reliability of range of motion measurement in the knee joint using a digital compass goniometer combined with inclinometer with standard range of motion measurement from roentgenographic picture. MATERIAL AND METHOD: Range of flexion and extension of the knee joint in volunteer participants was measured by the newly developed digital compass goniometer combined with inclinometer (DCG). The results were compared with range of knee joint motion obtained from standard roentgenographic picture by intraclass correlation coefficient. RESULTS: Range of motion of knee joint measured by DCG correlated very well with the data obtained from standard knee roentgenographic picture. The intraclass correlation coefficient equals 0.973. CONCLUSION: The digital compass goniometer was a reliable tool to measure knee joint range of motion in flexion and extension plane.

Acetabular position setting in total hip arthoplasty by using V-inclinometer.

The abduction angle of the acetabular implant position is important in the process of total hip arthroplasty. The authors evaluated the potential benefit of a V-inclinometer in the prediction of the abduction angle. To evaluate the accuracy of the V-inclinometer, acetabular cups were inserted in 50 cadaveric pelvises. The abduction angle from V-inclinometer and digital photograph were compared and analyzed using paired t-test. There was no statistical difference of the acetabular abduction angle between digital photograph and V-inclinometer (P > 0.05). The V-inclinometer can be used to predict the abduction angle on a cadaveric pelvis, suggesting that it could be a useful adjunct in clinical practice.

Randomized controlled trial between surgery and aspiration combined with methylprednisolone acetate injection plus wrist immobilization in the treatment of dorsal carpal ganglion.

Dorsal carpal ganglion is one of the most common benign tumors of the hand. Many treatment modalities had been proposed and yielded the same success rate. In the present study, the authors conducted a randomized controlled trial to compare the success of treatment between surgery and aspiration combined with methylprednisolone acetate injection plus wrist immobilization. There were 28 patients enrolled and randomized into two treatment groups. Only 24 patients were available for the final follow up at 6 months. According to the present study, dorsal carpal ganglion was more common in females (83.3%) at an average age of 30 years. Pain was the most common presenting symptom (58.3%). The success by excision was 81.8% and by aspiration combined with methylprednisolone acetate injection plus wrist immobilization was 38.46%. The p-value was 0.047 by Fisher exact test. The present study has clearly shown that surgical excision gave a better success rate in the treatment of dorsal carpal ganglion.