An Open-Labeled Randomized Prospective Multi-center Study to Evaluate the Efficacy and Safety of Intra-articular Injection of OSSINEXT™, an Autologous Growth Factor Concentrate (AGFC) Compared to Hyaluronic Acid (HA) in Knee Osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is known as degenerative arthritis and is the second most common rheumatologic problem with a prevalence of 22%-39% in India. Knee OA (KOA) is a major cause of mobility impairment, particularly among females. Non-surgical treatment options for KOA include intra-articular injections of platelet-rich plasma (PRP) and hyaluronic acid (HA). Most commercially available PRP preparation kits do not remove RBCs and WBCs which are detrimental to the healing effects. Wockhardt Regenerative Pvt. Ltd., Mumbai, India has developed a kit known as Ossinext™ which has an advantage over traditional PRP in that it eliminates RBCs and WBCs. This study was conducted to evaluate the effectiveness and safety of intra-articular injection of Wockhardt's Ossinext™ an autologous growth factor concentrate (AGFC) versus HA in KOA. METHODS:  Male and female patients in the age group between 30 and 75 years with confirmed KOA on radiological assessment with Grades I-III on the Kellgren-Lawrence Grading Scale and with visual analog scale (VAS) pain score of 4 or more (on the numeric rating scale) in spite of taking non-steroidal anti-inflammatory drugs (NSAIDs) since past 2 weeks were considered for study participation. This was an open-labeled study and eligible patients were randomly allocated to AGFC or HA in a 1:1 fashion. Three intra-articular injections were given in the affected knee joint, i.e. at baseline, month 1, and month 2 visits. Patients were evaluated at regular intervals, i.e. at months 5, 8, and 11 for primary and secondary endpoints. The primary efficacy endpoint for this study was change from baseline in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores at month 11 whereas the secondary efficacy endpoints were change from baseline of VAS pain scale at months 1, 2, 5, 8, and 11 as well as change from baseline of WOMAC, KOOS (Knee and Osteoarthritis Outcome System), and IKDC (International Knee Documentation Committee) scale at month 5, 8, and 11. For analysis a mixed model for repeated measures was used. RESULTS:  Out of the 100 patients who were enrolled, 50 patients each were randomized to AGFC and HA arm. The results were analyzed from 99 patients (49 for AGFC and 50 for HA) who met the criteria for the modified intent to treat (mITT) population. At month 11 on the WOMAC scale, there was greater improvement seen with Ossinext™ compared to HA group which was also statistically significant with p-value of 0.0332. Within the group, there was statistically significant improvement before and after treatment in all scales, i.e. WOMAC, KOOS, IKDC, and VAS at all time points, i.e. months 5, 8, and 11 with a p-value as low as <0.0001. Within the group, the VAS score showed statistically significant improvement even at months 1 and 2 as well. A total of 24 patients reported 37 adverse events (AEs) during the study, most common being pain, pyrexia and swelling but none of the AEs reported during the study were considered as severe in intensity. There were no safety concerns reported. CONCLUSIONS: In conclusion, greater and statistically significant improvement was seen with Ossinext™ in WOMAC scores at month 11 compared to HA. Ossinext™ also showed marked statistically significant improvement from before treatment to after treatment in the WOMAC, KOOS, IKDC, and VAS scales used for the assessment of KOA with a p-value as low as <0.0001. Ossinext™ was also safe and well-tolerated.

Successful Reimplantation of an 18-cm-Long Extruded Femur in an Open Fracture: A Case Report.

CASE: A 45-year-old man presented with a Gustillo Anderson type III A open segmental right femur shaft fracture with intercondylar extension and with an 18-cm extruded segment of bone. After sterilization, the segment of bone was reimplanted. The fracture healed, and the patient is ambulant without support with no signs of any infection after 2 years of follow-up. CONCLUSIONS: In cases of open fracture with an extruded bone segment available, depending on the timing of presentation, soft tissue status, and level of contamination of the bone segment, reimplantation of the extruded bone can yield a satisfactory result.

Postoperative Cognitive Dysfunction in Indian Patients Undergoing Total Knee Replacement Under Spinal Anesthesia.

INTRODUCTION: Total knee replacement is a common surgical procedure in the elderly. The number of surgeries has increased owing to the increasing life expectancy of the population and better functional outcomes postsurgery. Postoperative cognitive dysfunction (POCD) is an identified entity postsurgery in elderly but most of the studies have been on patients undergoing cardiac and other nonorthopaedic surgeries. The studies have shown variable incidence due to selection bias. We studied the incidence and probable predictive factors of POCD in elderly Indian population undergoing total knee replacement under spinal anesthesia. MATERIALS AND METHODS: We designed a prospective, observational study at a single center including patients above 60 years of age undergoing total knee replacement under spinal anesthesia. Preoperative mini-mental scale examination, electrolytes, urea and creatinine levels were recorded. Postoperatively, mini mental scale evaluation (MMSE) was done 2 days postsurgery, at 3 months, 6 months, and 1 year follow-up. Laboratory values postoperatively were recorded. RESULTS: The average preoperative MMSE was 27 and declined to 25.4 on second postoperative day the value increased to 25.9, 26.6, and 27 at 3 months, 6 months, and 1-year follow-up, respectively. Sixty-three out of 600 patients developed POCD at second postoperative day. Forty-three patients showed recovery in subsequent visits and 20 patients had persistent dysfunction at the end of 1 year. Electrolyte imbalance, oxygen saturation, and age over 80 years were factors that showed statistically significant difference in multiple comparison analysis. CONCLUSION: In our study, we have found POCD to be a definitive entity which can cause short- and long-term cognitive defect in elderly Indian population undergoing total knee replacement and electrolyte imbalance, age, and oxygen saturation were the significant factors in the patients who developed POCD.