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Study design: Patient eligibility was evaluated during a screening visit before entry into the study.
To ensure patients were blinded to their treatment group assignment, each patient in each treatment group received 3 injections.
Patients received 3 weekly injections of HMW Sod. Hyaluronate followed by one arthrocentesis procedure; Multiple arthrocentesis are not used as a standard treatment for OA. The protocol was approved by the appropriate institutional review boards of each institution. Informed consent was obtained from all subjects prior to participation in the study. HMW Sod. Hyaluronate (molecular weight 3 million Dalton) were administered by IA injection. The Hyaluronate was purified from bacterial fermentation and manufactured under current Good Manufacturing Practices.
Study protocol: The study protocol required 10 patient visits, including the screening visit. Potential study participants returned for a baseline visit after washout of NSAID and analgesics (Week 0). At the baseline visit, patients who met the enrollment criteria were randomly assigned to one of the 3 treatment group and received the first of the series of the IA study treatments. Participant enrollment the radiographic eligibility of the patient was assessed using the K-L grading criteria Assessment included a history, physical examination (range of motion, presence and for synovitis or effusion), and a standing anterior-posterior radiograph. All patients were ≥40 years of age and were willing to discontinue all analgesics and NSAID 7 days before the injection and for the duration of the study. All patients had a diagnosis of knee OA according to the radiographic evidence of knee OA. (See Tables 1 and 2.)
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Click on icon to see table/diagram/imageStudy Result: Total 26 patients were in the age from 39 to 78 and female is roughly twice than male.
Patient demographics and baseline disease characteristics. The 26 patients (ATRI-III shows good improvement). (See Table 3.)
Click on icon to see table/diagram/imageEffect of HMW Sod. Hyaluronate on knee pain, stiffness, and function within treatment evaluable population (n=26), a statistically significant improvement from baseline was observed. Among treatment groups, all endpoints indicated clinical improvements in patients receiving HMW Sod. Hyaluronate.
The changes from baseline scores for all endpoints compared are shown in Table 8. (See Table 4.)
Click on icon to see table/diagram/imageDegenerative Osteoarthritis: According to Kellegren's radiation classification 18 cases on stage III, 6 cases on stage II, 2 cases on stage I. (See Table 5.)
Click on icon to see table/diagram/imageChanges by time passing: We evaluate the changes of Subject finding, Objective finding and routine monitoring for 4 weeks. As a result, showed significant improvement after injection. (See Table 6.)
Click on icon to see table/diagram/imageAdverse reaction: There were none findings of unwanted reaction during the 4 weeks of observation periods. (See Table 7.)
Click on icon to see table/diagram/imageDiscussion and Conclusion: The study in short term periods showed that HMW Sod. Hyaluronate (3 million dalton) intraartricular injection on knee joint was beneficial to improve patients' subjective symptoms and relief of pain. It is recommended to follow up study which will be required to increase number of patients with long periods. (See Table 8.)
Click on icon to see table/diagram/imageIntraarticular HMW Sod. Hyaluronate injection is an alternative therapeutic option for OA of the knee. This may provide clinical benefit to patients over the long tern by improving joint function and avoiding the potential GI, cardiovascular and renal side effects associated with chronic NSAID therapy and evaluation of the efficacy and safety of High Molecular Weight Sod. Hyaluronate in patients with OA of the knee in a randomized, multicenter trial.
The effectiveness of the 3 week injection regimen was masked by the high rate of response in the arthrocentesis group. A similar placebo effect was also observed in a previous study with the 3-injection regimen of saline in injection as the control been reported. Brandt, et al reported clinical improvement in WOMAC Pain, Patient Global assessments, Investigator Global assessments, and Pain on Standing compared to saline (control) injections.
In summary, the data demonstrate that high molecular weight Sod. Hhyaluronate (ATRI-III) is a safe product for treatment of knee osteoarthritis. These data indicate that ATRI-III seems to be effective in reducing the pain and symptoms associated with OA of the knee using a series of 3 week injections. The potential benefit for clinically significant pain reduction using ATRI-III outweighs the potential risk of a low rate of minor adverse effects.
