Efficacy and Safety of Pregabalin Prolonged Release-Etoricoxib Combination Compared to Etoricoxib for Chronic Low Back Pain: Phase 3, Randomized Study.

INTRODUCTION: Currently available treatments for chronic lower back pain (CLBP) do not adequately address both nociceptive and neuropathic components of pain. We evaluated efficacy and safety of fixed-dose combination (FDC) of low-dose pregabalin prolonged release 75 mg-etoricoxib 60 mg to address both pain components. METHODS: This randomized phase 3 trial conducted at 12 centres across India evaluated efficacy (based on mean change in numeric rating scale [NRS], Roland-Morris disability questionnaire [RDQ], visual analogue scale [VAS], patient global impression of improvement [PGI-I], clinical global impression of improvement [CGI-I] and rescue medication consumption) and safety of FDC in comparison to etoricoxib alone in adult patients with CLBP. Treatment duration was 8 weeks. RESULTS: Of the 371 patients screened, 319 were randomized and considered for efficacy and safety analysis. Both treatment groups had no significant difference in terms of demography and baseline disease characteristics. Significantly better outcomes with FDC compared to etoricoxib were observed at week 4 onwards. At week 8, both groups showed significant reduction in mean NRS score from baseline (- 4.00 ± 1.65 in FDC; - 2.92 ± 1.59 in etoricoxib) with mean NRS score being significantly less in the FDC group compared to etoricoxib group (3.26 ± 1.56 vs 4.31 ± 1.56; p < 0.0001). The FDC was more effective than etoricoxib in terms of significantly greater reduction in RDQ score (- 9.28 ± 4.48 vs - 6.78 ± 4.34; p < 0.0001) and VAS score (- 37.66 ± 18.7 vs - 28.50 ± 16.31; p < 0.0001) at week 8. The FDC was also better in terms of significantly more patients reporting their condition as 'very much better' (36.9% vs 5.0%; p < 0.0001) and clinicians reporting patient's condition as 'very much improved' (36.3% vs 5.7%; p < 0.0001). Overall, study medications were well tolerated. CONCLUSION: FDC of pregabalin and etoricoxib provided significant benefits in reducing pain and improving functional status compared with etoricoxib alone in patients with CLBP. Pregabalin prolonged release-etoricoxib FDC could be one of the treatment options for early and sustained pain relief and improvement in quality-of-life in treating CLBP as it addresses both neuropathic and nociceptive components of pain. TRIAL REGISTRATION: CTRI/2018/10/015886.

Low back pain is one of the most common causes of loss of productivity worldwide. About 60% of Indians suffer from low back pain at some point. Low back pain that persists for more than 3 months is classified as chronic low back pain which mostly includes both nociceptive and neuropathic components. Monotherapies, if prescribed, are not completely effective, as they generally only target either nociceptive or neuropathic components of pain. Multiple drugs are usually needed at multiple times a day, at higher doses for optimal effectiveness, and in most cases they have significant side effects if taken over prolonged periods and also add to the pill burden. To minimize treatment-associated adverse effects, and to increase treatment compliance, while addressing both the components of pain, we developed a fixed-dose combination of low-dose pregabalin prolonged release and etoricoxib. A phase 3 trial was designed to assess the efficacy and safety of the fixed-dose combination in comparison with etoricoxib alone in treating chronic low back pain. The combination demonstrated statistically and clinically significant improvement in patient-reported outcomes­pain, functionality and quality of life­as early as 4 weeks after starting the medication. No severe or serious adverse effects were reported. Thus, the combination of low-dose pregabalin prolonged release and etoricoxib could provide an option for optimal management of chronic low back pain. This would provide multiple benefits, such as addressing both nociceptive and neuropathic components of chronic low back pain, reducing drug-related adverse effects because of low dose, reducing pill burden and thereby increasing drug compliance.

Long-standing case of osteochondromatosis of the hip treated with uncemented modular bipolar hemiarthroplasty: A case report.

INTRODUCTION: Synovial chondromatosis is a rare synovial disorder characterized by the presence of benign loose bodies in the joint space. The affliction of the hip joint is rare. This entity usually goes undiagnosed as it is largely asymptomatic till complications such as secondary osteoarthritis secondary to degenerative changes, subluxation of hip, and fracture neck of femur ensue. CASE REPORT: A 46-year-old farmer presented with a 9-year long history of the left hip pain with restriction in flexion, extension, and internal rotation. He was diagnosed with synovial chondromatosis and had a history of undergoing arthroscopic debridement following which he was asymptomatic but relapsed after 6 months. We performed excision with uncemented modular bipolar hemiarthroplasty after confirming the diagnosis on plain radiographs and computed tomography. Significant recovery in the range of motion was noted postoperatively and the patient showed no signs of relapse in the follow-up period of 18 months. CONCLUSION: Treatment of synovial chondromatosis of the hip joint poses a challenge due to its complex anatomy.

Diagnosis and Arthroscopic Treatment of Synovial Chondromatosis of Glenohumeral Joint: A Case Report.

INTRODUCTION: Synovial chondromatosis is a rare benign entity with the presence of cartilaginous or osseous loose bodies in the synovium. It commonly involves the larger joints such as the knee, hip, ankle and rarely the shoulder joint manifesting with pain, swelling, and restriction of movements. The treatment of choice is surgical intervention in symptomatic patients using either the open or the arthroscopic approach. CASE REPORT: Here, we report a rare case of synovial chondromatosis affecting the right shoulder joint in a 23-year-old male with a 5-year disease duration who presented with progressive pain and restriction in movements which were impacting his routine activities. The loose bodies were removed using the arthroscopic approach combined with a partial synovectomy, and intra-articular methylprednisolone post procedure. The patient showed an excellent recovery in joint mobility within 4 weeks post-operatively, and there were no clinical signs of recurrence during a 6-month follow-up period. CONCLUSION: We believe that arthroscopic surgery is effective in the treatment of patients with synovial chondromatosis with advantages such as good visualization, lesser morbidity, and early return of functional activities.

Parosteal Lipoma of the Proximal Phalanx of Hand.

Parosteal lipomas are rare benign tumors accounting for less than 0.1% of all primary bone tumors. Only 3 cases of parosteal lipoma have been previously described affecting the distal and middle phalanges. We describe a case of parosteal lipoma in a 45-year-old man involving the proximal phalanx of the right middle finger. The tumor was marginally excised with the osseous attachment. There was no clinical or radiological recurrence at a follow-up of 2 years, with full range of movement at the proximal interphalangeal joint.

Functional Outcome of High Tibial Osteotomy in Patients with Medial Compartment Osteoarthritis Using Dynamic Axial Fixator -a prospective study.

INTRODUCTION: Medial Compartment Osteoarthritis of the knee is becoming a widespread problem. The surgical options include high tibial osteotomy, unicompartmental knee replacement, and total knee replacement. Replacement surgeries are not advised in the younger age group, so in these patients, high tibial osteotomy is the only option. In this study, we have assessed the functional and radiological outcomes of high tibial osteotomy done by hemicallostasis method. METHOD: We report the outcome of 30 patients (30 knees) who underwent hemicallostasis with a dynamic external fixator for medial compartment osteoarthritis of the knee. The radiological assessment was done with the help of Hip Knee Ankle angle. The functional scoring was done via Oxford knee score, IKDC, KOOS, and WOMAC score. RESULTS: At a mean follow up of 35 months, the preoperatively mean HKA angle was 172 ± 30. The mean HKA angle postoperatively was 184 ± 10. Appropriate correction of the HKA angle was achieved in 24 of 30 patients (80%). Whereas, there was under correction in 3 patients (10%) and overcorrection in 3 (10%) patients. All the functional scores showed significant improvement in the postoperative scores. There was a positive correlation between the HKA angle and oxford, IKDC, KOOS, and WOMAC Score. Complications like superficial pin tract infection were seen in 3 (10%) patients, deep infection in 1 (3%), and early union of osteotomy in 1 (3%) patient leading to revision of the osteotomy. . CONCLUSION: HTO is effective in improving pain, function, activity of daily living, and quality of life in patients suffering from medial compartment Osteoarthritis of the knee. Hip Knee Ankle Angle is an important parameter to restore for better functional outcomes. The Advantage of using a dynamic axial fixator is the precision in achieving calculated correction without any implant in the bone once the correction is achieved along with good healing rates.

Management of Forearm Deformity by Limb Reconstruction System in Children with Multiple Exostosis - A case Report.

INTRODUCTION: Osteochondroma is the group of benign bone tumours, which are composed of spongy bone covered by a cartilaginous cap. Patients with distal ulnar osteochondromas frequently cause forearm deformities with relative ulnar shortening, wrist joint deviation, and varus bowing. Surgical ulnar lengthening is necessary to restore the carpal balance. CASE REPORT: We report the case of multiple exostosis in a 13-year-old male with the right distal ulna osteochondroma with long-standing and progressive ulnar shortening and radial bowing treated with a limb reconstruction system. Our case is Type I Masada managed with excision of distal ulna osteochondroma and gradual ulnar lengthening without osteotomy of the radius. CONCLUSION: Progressive ulna deformity can lead to increasing pain, joint instability, limited motion, and functional decline. For Type I, Masada ulnar lengthening is necessary, but over correction is inadvisable due to possible ulnocarpal impaction syndrome. As significant remodeling effects on the radius were observed, simultaneous radial correction can be delayed.

Ceramic liner fracture in ceramic on ceramic Total hip arthoplasty: A case report.

INTRODUCTION: Revision rates of total hip arthoplasty have decreased after introducing total hip arthroplasty using ceramic component due to reduce wear and osteolysis. CASE REPORT: 29 year old male case of bilateral hip avascular necrosis operated for bilateral hip THA presented 30 months after with complaint of squeaking, x-ray showing left ceramic liner fracture without any history of trauma. Revision of ceramic liner and head with ceramic on polyethylene was done. DISCUSSION AND CONCLUSION: Ceramic on ceramic articulation has the lowest wear rate among various articulations. However, there is a concern about ceramic implant fracture; therefore ceramic with polyethylene bearing could be a good choice.

Functional and radiological outcome in management of compound tibia diaphyseal fracture with AO monolateral fixator versus Limb reconstruction system.

INTRODUCTION: Tibia being the most common fractured long bone represents 36.7% of all long bone fractures in adults with open fracture comprises 23.5% of all tibial shaft fracture. The lack of the muscular covering over anteromedial aspect of the tibia and poor blood supply predispose open tibial fractures to a 10-20 fold increased risk of developing infection than open fracture in any other anatomical areas and a nonunion rate as high as 28% has been reported in the literature. METHODS: We did a prospective study at our institute from 2014-2016 comprising 40 patients with compound tibia diaphyseal fracture managed with AO monolateral external fixator (Group 1) (n = 20) and Limb reconstruction system (Group 2) (n = 20) as primary and definitive tool. Final assessment for bone results and functional results were done using ASAMI (Association of the study and application of the method of Ilizarov) score. RESULTS: In our study bony outcome by ASAMI score shows 6 (30%) patients had Excellent, 5 (25%) patients had Good and 9 (45%) had Poor bony outcome from Group I. In group II, 12 (60%) patients had Excellent, 4 (20%) patients had Good, 2 (10%) patients had Fair, and 2 (10%) had Poor bony outcome. The functional outcome by ASAMI score shows 3 (15%) patients had Excellent, 8 (40%) patients had Good, 5 (25%) patients had Fair, 3 (15%) had Poor bony outcome from Group I. In group II, 9 (45%) patients had Excellent, 7 (35%) patients had Good, 2 (10%) patients had Fair, and 2 (10%) had Poor functional outcome. CONCLUSION: Limb reconstruction system (LRS) offers several advantage over AO monolateral external fixator such as ease of application, versatility, stronger fixation, less fixator related complications, early weight bearing and early bony union for management of compound tibia diaphyseal fracture as primary and definitive tool.