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.

Seniors, risk and rehabilitation: broadening our thinking.

PURPOSE: Conceptualizations of risk in seniors' rehabilitation emphasize potential physical injury, functional independence and cost containment, shifting rehabilitation from other considerations essential to promoting a satisfying life. In a two-day multidisciplinary planning meeting we critically examined and discussed alternatives to dominant conceptualizations. METHOD: Invitees reflected on conceptualizations of risk in stroke rehabilitation and low vision rehabilitation, identified and explored positive and negative implications and generated alternative perspectives to support rehabilitation approaches related to living a good life. RESULTS: Current risk conceptualizations help focus rehabilitation teamwork and make this work publically recognizable and valued. However, they also lead to practice that is depersonalized, decontextualized and restrictive. Further research and practice development initiatives should include the voices of clinicians and seniors to more adequately support meaningfully living, and foster safe spaces for seniors and clinicians to speak candidly, comprehensively and respectfully about risk. To ensure that seniors' rehabilitation targets a satisfying life as defined by seniors, increased focus on the environment and more explicit examination of how cost containment concerns are driving services is also necessary. CONCLUSION: This work reinforced current concerns about conceptualizations of risk in seniors' rehabilitation and generated ways forward that re-focus rehabilitation more on promoting a satisfying life. Implications for rehabilitation In seniors' rehabilitation, considerations of risk focus on physical injury, functional dependence and cost containment. Focus on provider-defined risk of physical injury limits examination of patient goals and patients' histories of judging and dealing with risk. Focus on functional dependence and cost containment may lead to practice that is depersonalized and decontextualized. Abandonment of ableist and ageist thinking and an explicit focus on person-centered definitions of risk and a satisfying life are recommended.

Cerebral venous sinus thrombosis in Saudi Arabia.

OBJECTIVE: To analyze the clinical patterns, etiologies, treatment, and outcome of cerebral venous sinus thrombosis (CVST) in 2 major cities of Saudi Arabia, Jeddah and Al-Baha. METHODS: One hundred and eleven patients diagnosed as CVST were identified from the medical records at King Abdulaziz Medical City, Jeddah, and King Fahad Hospital, Al-Baha, Saudi Arabia, from January 1990 through November 2010. We retrospectively analyzed the data, compared it with local and international studies, and reviewed the literature. RESULTS: There were 92 adults and 19 children. Among adults, females predominated, while more boys were affected than girls. The mean age of onset was 29.5 years. The most common clinical presentations were headache, focal neurologic deficits, seizures, papilledema, and decreased level of consciousness. The main risk factors identified were pregnancy/ puerperium, antiphospholipid antibody syndrome, oral contraceptive pills, malignancy, and infections. Multiple sinuses were affected in 51 patients (45.9%). When a single sinus was involved, the superior sagittal sinus (24.3%) was the most common. Seventy-four patients recovered completely, 23 patients recovered partially, and 10 patients died. Bad prognostic factors included incurable co-morbid conditions, late presentation, and status epilepticus. CONCLUSION: Pregnancy/puerperium was the most common etiological factor in our series. Clinical features were similar to international series. Behcet`s disease was not a major etiological factor in our series. Most patients had involvement of multiple sinuses. Prompt treatment with anticoagulation resulted in complete or partial recovery in 87.4% of patients.