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Using intra-articular allogenic lyophilized growth factors in primary knee osteoarthritis: a randomized pilot study.
Objective: Investigating the safety in addition to clinical and structural efficacy of allogenic lyophilized growth factors (L-GFs) in patients with symptomatic primary knee osteoarthritis. Design: A prospective, open-label pilot study. A total of 31-patients randomized into non-intervention and intervention groups. Materials & methods: The intervention group received two intra-articular doses at baseline and after 2-months. Post-injection complications were documented, and the efficacy was assessed by Western Ontario and McMaster Universities Osteoarthritis Index scores and ultrasonography. Results: One dropout from the intervention group. The percentage of improvement of mean Western Ontario and McMaster Universities Osteoarthritis Index-scores and ultrasonography-detected effusion were statistically significant in the intervention group compared with the non-intervention. A brief, mild, post-injection pain was reported by all intervention group. Conclusion: This study provides the safety of intra-articular injection of allogenic L-GFs in knee osteoarthritis. The conclusion of efficacy was limited by small sample size and lack of control injection. Clinical trial registration: NCT04331327 (ClinicalTrials.gov, retrospectively registered).
Lay abstract Knee osteoarthritis affects many people after middle age. It causes progressive joint damage and may lead to disability. To date, there is no medical treatment that can stop disease progression and restore knee function. In this study, we tested a novel treatment for knee osteoarthritis. Patients who received knee injection with growth factors showed better results in joint pain and swelling. Growth factors were isolated from donated platelets and were assured that they were free of pathogens.
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