RESUMO
Background: Prediction of hamstring tendon autografts is essential when planning a ligament reconstruction surgery. This is especially important in cases of multiple ligament reconstruction surgeries. This study was designed to predict the dimensions of 5-stranded hamstring grafts from anthropometric parameters in patients undergoing anterior cruciate ligament (ACL) reconstruction surgery. Methods: 172 patients undergoing ACL reconstruction with hamstring autografts were included in the study. Preoperative parameters included age, gender, height, weight, body mass index (BMI), thigh length, thigh circumference, and tibia length; intraoperative parameters included semitendinosus (ST) and gracilis (G) length and diameter, final 5-stranded graft length and diameter. Pre-operative data was correlated with intra-operative data using tests of significance. Results: Height, tibia and thigh length were greater in males (p < 0.05) whereas BMI was greater in females (p < 0.05). G and ST length alongwith 5-stranded graft length and diameter were significantly greater in males (p < 0.05). The graft dimensions could be correlated with the pre-operative anthropometric parameters using specific equations. This was applicable to the lengths and diameters of ST, G and 5-stranded grafts. We also noted that an increase in age was associated with a reduction in graft dimensions except for the diameter of G graft in females and length of 5-stranded grafts in males. Conclusion: 5-stranded hamstring graft dimensions can be reliably predicted using anthropometric parameters and this eases surgical planning.
RESUMO
BACKGROUND: Our study aimed to compare efficacy and safety of Hetero's adalimumab (Mabura®, Hetero Biopharma Limited) versus reference adalimumab (Humira®, Abbvie Inc.) in Indian patients with active rheumatoid arthritis (RA) concomitant on methotrexate (MTX) therapy. METHODS: Patients (n = 168) were randomized (2:1) to receive either test or reference product for 24 weeks with concomitant MTX. Proportion of patients achieving American College of Rheumatology 20 (ACR20) criteria at week 12 was the primary endpoint. Changes in Disease Activity Score of 28 joints-C-reactive protein (DAS28-CRP), Health Assessment Questionnaire-Disability Index (HAQ-DI), and patients achieving ACR20 at week 24, ACR50/70 at weeks 12 and 24 were secondary endpoints. RESULTS: Patients achieving ACR20 responses with test (96.43%) were similar to reference (96.43%) in intention-to-treat (ITT) analysis at week 12. Proportional difference (PD) between groups (PD [95% CI] 0.0 [- 6.0, 6.0], p = 1.000) for ACR20 at week 12 for ITT analysis showed lower limit of the two-sided 95% CI was above the pre-specified noninferiority margin of - 15%. Similar trend in PP analysis (PD [95% CI] 0.0 [- 0.03, 0.07], p = 1.000), confirmed therapeutic equivalence. No significant difference was noted between arms for patients attaining ACR20 at week 24 and ACR50/70 at weeks 12 and 24 (all p > 0.05). DAS28-CRP and HAQ-DI were similar between groups. Total of 54 patients reported 88 AEs during the study. Out of these, 60 AEs were reported in 34 patients with Hetero-Adalimumab and 28 AEs were reported in 20 patients with Reference-Adalimumab. Total two patients, one in each group reported two serious adverse events (Sinusitis and Viral infection) during the study and resolved completely. No deaths and no life threatening AEs were reported. CONCLUSION: Results demonstrated Hetero's adalimumab is as effective and well tolerated as reference adalimumab in patients with active RA concomitantly on MTX therapy. TRIAL REGISTRATION: CTRI/2016/04/006884, Registered on 28/04/2016.