Effect of Preoperative Vitamin D Levels on Functional Performance after Total Knee Arthroplasty

Rajesh Navin Maniar,Aniket Machindra Patil,Adit Rajesh Maniar,Bharat Gangaraju,Jaivardhan Singh 대한정형외과학회 2016 Clinics in Orthopedic Surgery Vol.8 No.2

Background: Low vitamin D levels affects muscle function. Vitamin D and calcium deficiency cause osteomalacic myopathy and poor functional recovery after hip fractures. The relationship of vitamin D and functional performance after total knee arthroplasty (TKA) is not previously reported. Methods: Influence of vitamin D on functional performance before and after TKA was reviewed retrospectively in 120 patients. Of these, 64 had vitamin D deficiency (25-hydroxy vitamin D < 30 ng/mL) preoperatively. All 120 patients received vitamin D oral supplementation postoperatively. Functional parameters including Western Ontario and McMaster Osteoarthritis Index (WOMAC), Short-Form Health Survey questionnaire, and Knee Society Score were assessed pre- and postoperatively at 3 months. Results: Preoperative function was significantly lower in osteoarthritic patients with vitamin D deficiency (WOMAC score; p = 0.040), but at 3 months all functional scores were similar. Conclusions: We concluded that vitamin D deficiency has a negative effect on function in knee osteoarthritic patients. However, postoperative vitamin D supplementation can lead to functional recovery in these patients. Thus, TKA should not be delayed in vitamin D deficient patients; rather supplementation in the postoperative period is preferable to achieve comparable functional outcome at 3 months to patients with vitamin D sufficiency.

WHO Class of Obesity Influences Functional Recovery Post-TKA

Rajesh N Maniar,Parul R Maniar,Tushar Singhi,Bharat Kumar Gangaraju 대한정형외과학회 2018 Clinics in Orthopedic Surgery Vol.10 No.1

Background: No study in the literature has compared early functional recovery following total knee arthroplasty (TKA) in the obese with the nonobese using World Health Organization (WHO) classes of obesity. Our aim was to compare functional scores and flexion post-TKA in each class of obesity as per WHO classification against a matched control group of nonobese patients. Methods: Records of 885 consecutive primary TKA patients (919 knees) operated by a single surgeon were reviewed. The first 35 knees in each class I, class II and class III obesity group during the study period were then matched with a similar number of knees in nonobese TKA patients during the same period. Functional scores recorded pre- and postoperatively at 3 months and 1 year were Western Ontario and McMaster Osteoarthritis Index (WOMAC), Short-Form Health Survey (SF-12) score, and Knee Society Score (KSS). Results: There was no difference in any parameter between the class I obese and matched nonobese at any assessment point. In the class II obese, as compared to the nonobese, there was no difference in any parameter preoperatively and 3 months postoperatively. However, 1 year postoperatively, the SF-12 physical subscore was lower in the class II obese than the nonobese (44.7 vs. 48.6, p = 0.047) and the WOMAC score was significantly higher (15.8 vs. 9.7, p = 0.04). In the class III obese, the WOMAC score was significantly higher than the nonobese (58.1 vs. 44.3, p < 0.001 preoperatively; 15.7 vs. 8.1, p = 0.005 at 1 year) and KSS was significantly lower (83.5 vs. 96.5, p = 0.049 preoperatively; 172 vs. 185; p = 0.003 at 1 year). Knee flexion was significantly lower in the class III obese than the nonobese (95 vs. 113; p < 0.001 preoperatively; 120 vs. 127; p = 0.002 at 1 year). Conclusions: The class I obese can expect good early and late functional recovery as the nonobese. The class II obese can expect comparable early functional recovery as the nonobese but their late function may be lesser. The class III obese would have poorer functional scores and lesser knee flexion postoperatively compared to the nonobese. However, compared to their own preoperative status, there is definite improvement in function and knee flexion.

Role of Suction Drain after Knee Arthroplasty in the Tranexamic Acid Era: A Randomized Controlled Study

Rajesh Navin Maniar,Prashant Pradhan,Nishit Bhatnagar,Adit Maniar,Rohan Bidwai,Pranav Bindal 대한정형외과학회 2019 Clinics in Orthopedic Surgery Vol.11 No.1

Background: Postoperative suction drains are used after total knee arthroplasty to avoid intra-articular hematoma formation although they can increase blood loss due to a negative suction effect. The use of tranexamic acid to reduce blood loss may nullify this. The aim of this study was to compare outcomes in patients undergoing total knee arthroplasty with or without drains and to analyze whether the drain’s diameter also has an impact. Methods: This is a prospective randomized study of patients undergoing unilateral total knee arthroplasty performed by a single surgeon. The study population was divided into three groups (A, 10G drain; B, 12G drain; and C, no drain). Pain, blood loss, swelling, wound-related complications, functional outcomes and questionnaire-based outcomes were assessed postoperatively. Results: Each group had 35 patients comparable in most demographic and pre- and intraoperative characteristics. During the first 6 hours postoperatively, opioid consumption was significantly higher when the drain was not used (p = 0.036). At 3 months postoperatively, new Knee Society Score (NKSS) was highest with the use of 12G drain (p = 0.018). However, NKSS at 1 year was comparable across the three groups. With the use of tranexamic acid, blood loss and incidence of soakage of dressing were unaffected by the presence or absence of a drain. The calf girth, suprapatellar girth, soakage of dressing and range of motion were comparable in all three groups. There was no incidence of surgical site infection or deep vein thrombosis. Conclusions: Presence of a suction drain significantly reduces opioid consumption during the first 6 hours after total knee arthroplasty. Use of a drain made no difference to the functional outcome at 1 year postoperatively. With the use of tranexamic acid in total knee arthroplasty, the total blood loss and the requirement of blood transfusion were unaffected by the presence or absence of closed suction drainage or by the bore of the drain used. The clinical parameters such as swelling, range of motion, infection and deep vein thrombosis also remained the same.

Vitamin D Trajectory after Total Knee Arthroplasty: A Method for Quick Correction in Deficient Patients

Rajesh N Maniar,Adit R Maniar,Ditesh Jain,Nishit Bhatnagar,Arpit Gajjar 대한정형외과학회 2021 Clinics in Orthopedic Surgery Vol.13 No.3

Background: It has been widely reported that vitamin D (vit D) affects preoperative, postoperative, and long-term outcomes after total knee arthroplasty (TKA). Our aim was to study vit D trajectory after TKA and compare effects of oral versus intramuscular (IM) supplementation in insufficient patients and assess its effects on immediate functional recovery in the first 2 weeks after TKA. Methods: Vit D levels < 30 ng/mL are considered insufficient. We prospectively enrolled 60 patients (20 per group): group I, vit D sufficient patients; group II, vit D insufficient patients given IM supplementation (cholecalciferol 6,00,000 IU); and group III, vit D insufficient patients given oral supplementation (cholecalciferol 600,000 IU). Vit D levels, knee flexion, Timed Up and Go (TUG) test results, and visual analog scale (VAS) score were recorded preoperatively and postoperatively on day 3 and 14. Results: In group I, mean preoperative vit D significantly dropped at postoperative day (POD) 3 and POD 14 (p = 0.001). In group II, mean preoperative vit D rose at POD 3 and rose significantly at POD 14 (p = 0.001). In group III, mean preoperative vit D increased significantly at both POD 3 and POD 14 (p < 0.001). Also, in group III, the rise in vit D was significantly higher than that in group II both at POD 3 and POD 14 (p < 0.05). In group III, 19 of 20 insufficient patients became sufficient on POD 3 and all 20 by POD 14. In group II, even by POD 14, only 11 of 20 insufficient patients became sufficient. Functional parameters (flexion, change in flexion, TUG test results, and VAS score) were comparable (p > 0.05) in all groups. Changes in TUG test showed a significant increase in group II (48.5 seconds) when compared to group I (35.5 seconds) at POD 3 (p < 0.05), suggesting a slower recovery. It remained comparable (p > 0.05) between group III and group I. Conclusions: We found that vit D insufficient patients can be rapidly supplemented on the morning of surgery with a large dose of oral cholecalciferol 600,000 IU, and the effect was consistent over 2 weeks after surgery. Orally supplemented vit D insufficient patients also showed functional recovery comparable to vit D sufficient patients. IM supplementation increased vit D levels only at 2 weeks and the rise was significantly lower than oral supplementation. Interestingly, approximately 25% of vit D sufficient patients who were not supplemented after TKA became insufficient in the first 2 weeks postoperatively.

Comparison of Patellofemoral Outcomes between Attune and PFC Sigma Designs: A Prospective Matched-Pair Analysis

Rajesh Navin Maniar,Nishit Bhatnagar,Rohan Bidwai,Ankur Dhiman,Debashish Chanda,Nishant Sanghavi 대한정형외과학회 2022 Clinics in Orthopedic Surgery Vol.14 No.1

Background: Attune (DePuy Synthes) prosthesis was designed to overcome patellofemoral complications associated with PFC Sigma (DePuy Synthes) prosthesis. The aim of our study was to compare the incidence of anterior knee pain (AKP), patellofemoral crepitus (PCr), and functional outcome between them. Methods: This prospective matched-pair study was conducted between January 2014 and June 2015, during which 75 consecutive Attune total knee arthroplasties (TKAs) were matched with 75 PFC Sigma TKAs based on age, sex, body mass index, pathology, and deformity. A single surgeon performed all the operations with aid of computer navigation, using a posterior-stabilized prosthesis with patellar resurfacing. Outcome was assessed by new Knee Society Score (NKSS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. AKP and PCr were assessed by a patient-administered questionnaire till 2 years of follow-up. Three pairs were lost to follow-up and finally 72 pairs were analyzed. Results: One patient in each group reported AKP and 1 patient from each group had PCr at 2 years postoperatively. None of these patients required additional surgery. The incidence of lateral retinacular release was higher with PFC Sigma (5/72) than Attune (2/72); however, this was statistically not significant (p = 0.4). The Attune group had a significantly greater range of motion (ROM) at 3 months postoperatively (p = 0.049). At final follow-up, ROM was comparable between two prosthesis designs. NKSS and WOMAC scores were also comparable between the groups. Conclusions: We observed that both Attune and PFC Sigma had a low and comparable incidence of AKP and PCr up to 2 years of follow-up. The Attune group achieved a significantly greater ROM at 3 months postoperatively. At 2 years of follow-up, both prostheses had excellent and comparable clinical and functional results.

Influence of physicochemical properties of model compounds on their release from biodegradable polyanhydride devices

Park, Eun-Seok,Maniar, Manoj,Shah, Jaymin C. 성균관대학교 약학연구소 1997 成均藥硏論文集 Vol.9 No.1

A new class of fatty acid dimer-based polyanhydride, polycfatty acid dimer-sebacic acid) (P(FAD-SA)), was reported to have desired physicochemical and mechanical properties for a biodegradable device and believed to undergo pure surface erosion. The objectives of this study were to determine if P(FAD-SA) undergoes pure surface erosion, and to identify the factors governing the release characteristics and mechanism from polyanhydride devices at various pHs. Three model compounds, mannitol (small M_w, highly water soluble), inulin (large M_w, moderately water soluble) and stearic acid (medium M_w, extremely lipophilic) were incorporated at 10% w/w in disk-shaped P(FAD-SA, 50:50 w/w) devices and the release of the compounds studied from pH 1-9. All the three model compounds were released faster at alkaline pH than at acidic pH (pH 9>pH 7.4>pH 1-5), suggesting that the release of model compounds was dependent on the catalyzed erosion of polyanhydride. However, erosion was not the sole release rate controlling mechanism for these model compounds. Highly water soluble mannitorl and inulin were released rapidly at acidic pH, when erosion of polyanhydride is negligible. Mannitol released faster than inulin, which was released faster than lipophilic stearic acid at all pH, suggesting that the hydrophilic/hydrophobic nature of the loaded compound influenced its release significantly. the observed release profiles were significantly higher, and did not match the release profiles predicted from erosion rates of the mannitol and inulin devices, however they were closer for stearic acid devices. Althoug inulin was released rapidly in the initial phase (40-50%), only 60-70% inulin was released over a 6-week period compared to 100% release of mannitol. The large molecular size of inulin may have hindered its diffusion through water-filled pores and channels observed in the devices during release, which may have resulted in the majority of inulin being still trapped in the devices. Although various contributing factors in overall release were identified, a single release kinetic model could not explain the release profiles of all the loaded compounds under the different pH conditions. The complete release profiles could be decribed by first order kinetics, however the initial release profiles of all the model compounds were described very well by zero order kinetics. The release rates of mannitol and inulin were influenced by both the erosion rates and the intrinsic dissolution rates unlike release rates of stearic acid which correlated closely with erosion rates. This may be due to the fact that different release machanisms, such as diffusion, dissolution and erosion all play a significant role in overall release of compound from this newly developed P(FAD-SA) device. However, the contribution of each process to overall release may vary as a function of pH, the nature of the compound and polymer erosion. In conclusion, the results suggest that P(FAD-SA, 50:50 w/w) is undergoing bulk erosion rather than the desired surface erosion. If it did undergo surface erosion, release characteristics would be independent of the physicochemical nature of the incorporated compound and release kinetics would be zero order from disk-shaped devices irrespective of the nature of the loaded compound.

Biodegradable polyanhydride devices of cefazolin sodium, bupivacaine, and taxol for local drug delivery : preparation, and kinetics and mechanism of in vitro release

Park, Eun-Seok,Manoj Maniar,Shah, Jaymin C. 성균관대학교 약학연구소 1998 成均藥硏論文集 Vol.10 No.1

The overall objective was to design and evaluate biodegradable implants for local drug delivery in clinical conditions and/or diseases described below, which are currently treated with systemic administration of drugs. Local delivery of cefazolin is desired in conditions such as osteomyelitis, soft-tissue infection and for prevention of post-surgical infections. Similarly, implanting a biodegradable device loaded with taxol in the cavity created by tumor resection will provide high local concentrations of taxol killing the malignant cells which may have survived the surgery, thus preventing metastasis and regrowth of the tumor and also prevent the systemic side effects of taxol. Prolonged reversible nerve blockade required in a number of clinical situations involving acute or chronic pain such as post-surgical pain following herniorrhaphy and thoracotomy can be achieved with local delivery of bupivacaine. Therefore, disk-shaped implants of polyanhydride, P(FAD-SA, 50:50 w/w), loaded with 10% w/w of cefazolin sodium, taxol and bupivacaine were prepared and evaluated for content uniformity and in vitro release characteristics for the above mentioned local drug delivery applications. All of cefazolin sodium was released in 14 days while 90% bupivacaine was released in 35 days. In striking contrast, taxol was released very slowly, and only 15% taxol was released in 77 days. The overall release appeared to be following first order kinetics, and the initial linear profile was fitted to zero order kinetics to obtain release parameters. Since cefazolin is highly water soluble and bupivacaine is moderately water soluble, compared to taxol which is extremely lipophilic, the aqueous solubility of the incorporated drug appeared to influence its release characteristics. Very good correlation was observed between release parameters (A_0, K_0) and the solubility and intrinsic dissolution rate (IDR) of drugs suggesting that the hydrophilic/hydrophobic nature of the drug influences its release from polyanhydride devices. Since polyanhydrides are believed to undergo pure surface erosion, release of the incorporated drug should be independent of its physicochemical properties, however the results presented in this study suggest otherwise. Therefore, P(FAD-SA, 50:50 w/w) may not be undergoing surface erosion, and that diffusion and dissolution properties of the drug in addition to erosion characteristics of the polyanhydride appear to play a role in drug release. Implants prepared and evaluated in this study released cefazolin, bupivacaine and taxol for a prolonged duration of time; however, depending upon the desired duration of release, an appropriate polyanhydride will have to be selected. For example, taxol was released so slowly that a more hydrophilic polyanhydride may have to be selected to release all the drug in a shorter period of time to be of any therapeutic use. Cefazolin implants released the drug for a sufficient duration for osteomyelitis and soft-tissue infection but the release was more prolonged than required for prevention of post-surgical wound infection.

Water uptake in to polyanhydride devices : kinetics of uptake and effects of model compounds incorporated, and device geometry on water uptake

Park, Eun-Seok,Maniar, Manoj,Shah, Jaymin 성균관대학교 약학연구소 1996 成均藥硏論文集 Vol.8 No.1

Polyanhydrides are known as surface eroding biodegradable polymers since they are hydrophobic, which is believed to prevent penetration of water into the bulk and hence only the labile bonds on the surface are hydrolyzed. We wanted to test the hypothesis that polyanhydrides, specifically poly(fatty acid dimer-sebacic acid; FAD-SA) undergo pure surface erosion. If P(FAD-SA) does indeed undergo pure surface erosion, very little water should be present in the device since the polymer is hydrophobic and hydrolyzed on contact with water. An understanding of water uptake is also necessary to predict the stability and release of the incorporated drug. The specific aims of this study were to establish the rate of water uptake into P(FAD-SA) devices of cylinder and disk shapes at various pH conditions, and to study the effect of loaded model drug compounds (having different molecular size, aqueous solubility and dissolution rate) on water uptake. The model compounds included: mannitol, inulin and stearic acid, loaded at 10%(w/w) in disk-shaped devices. Water uptake was estimated from the amount of tritiated water found in the devices after they were soaked and gently mixed with buffers (pH 1-9) containing tritiated water (1μCi/ml) at various time intervals. The results showed that water uptake by the devide is a function of pH (pH 9>pH 7.4≫pH 1-5). Significantly higher amount of water was taken up at pH 7.4 and 9.0 (8-9% (v/v) for cylindrical devices, 15-25% (v/v) for disk-shaped device in 2 weeks), compared to less than 5% (v/v) uptake between pH 1 and 5. Disk-shaped devices showed a faster uptake rate compared to cylinder-shaped devices due to their higher surface area to volume ratio. The loaded compounds had no significant effect on either the water uptake profile or water uptake kinetics at all pH values examined. From the large amount of water (up to 20% (v/v)) found in the devices at pH 7.4 and pH 9.0, it appears that P(FAD-SA) does not undergo pure surface erosion. The photomicrographs of the devices at various stages of water uptake showed channels on the rough surface indicative of bulk erosion rather than pure surface erosion.

Leg and arm adiposity is inversely associated with diastolic hypertension in young and middle-aged United States adults

Aayush Visaria,David Lo,Pranay Maniar,Bhoomi Dave,Parag Joshi 대한고혈압학회 2022 Clinical Hypertension Vol.28 No.-

We sought to determine the association between appendicular adiposity and hypertension, with the purpose of better understanding the role of body fat distribution on blood pressure (BP).We included 7411 adults aged 20 to 59 who were not taking antihypertensives and without cardiovascular disease from the 2011 to 2018 National Health and Nutrition Examination Surveys. Leg & arm adiposity, determined via dual-energy X-ray absorptiometry scans, was defined as percent of total body fat present in legs/arms (leg/total%, arm/total%). Measures were categorized into sex-specific tertiles. We estimated change in BP and odds ratios (ORs) of hypertension (BP ≥ 130/80) and hypertension subtypes using multivariable, survey design-adjusted linear & logistic regression, respectively. Of the participants, 49% were female, the average (standard deviation) age was 37.4 (0.3) years, and 24% had hypertension. Those in the highest tertile (T3) of leg/total% had 30% decreased adjusted ORs (aOR) of hypertension compared to the lowest tertile (T1; aOR, 0.70; 95% confidence interval [95% CI], 0.55–0.89). This association was not significant for arm/total% (0.89, 0.68–1.17). T3 of leg/total% was associated with 49% lower, 41% lower, and unchanged relative odds of isolated diastolic hypertension (IDH), systolic-diastolic hypertension (SDH), and isolated systolic hypertension (ISH) compared to T1 (IDH: 0.51, 0.37–0.70; SDH: 0.59, 0.43–0.80; ISH: 1.06, 0.70–1.59). For every 10% increase in leg/total%, diastolic BP decreased by an adjusted mean 3.5 mmHg (95% CI, − 4.8 to − 2.2) in males and 1.8 mmHg (95% CI, − 2.8 to − 0.8) in females ( P < 0.001 for both). A greater proportional distribution of fat around the legs is inversely, independently associated with hypertension, and more specifically, diastolic hypertension (IDH and SDH).