A novel cell-free formulation for the treatment of knee osteoarthritis generates better patient-reported health outcomes in more severe cases
| Autor: | Juan Paz-Garcia, Jose Valtierra-Alvarez, Iram P. Rodriguez-Sanchez, Josuel Delgado-Enciso, Daniel Tiburcio-Jimenez, Bertha Alicia Olmedo-Buenrostro, Ivan Delgado-Enciso, Gabriel Ceja-Espiritu, Jorge E Plata-Florenzano, Margarita L Martinez-Fierro, Sergio A Zaizar-Fregoso, José Guzmán-Esquivel, Jorge Preciado-Ramirez, Brenda Paz-Michel, Carlos E Barajas-Saucedo |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Cell free Osteoarthritis Health outcomes Injections Intra-Articular 03 medical and health sciences 0302 clinical medicine lcsh:Orthopedic surgery Internal medicine Insomnia Humans Medicine Single-Blind Method Patient Reported Outcome Measures Aged Pain Measurement 030304 developmental biology 030203 arthritis & rheumatology 0303 health sciences business.industry Regeneration (biology) Cartilage Middle Aged Osteoarthritis Knee medicine.disease Arthralgia Clinical trial lcsh:RD701-811 medicine.anatomical_structure Female Steroids Surgery medicine.symptom business |
| Zdroj: | Journal of Orthopaedic Surgery, Vol 28 (2020) |
| ISSN: | 2309-4990 |
| DOI: | 10.1177/2309499020938121 |
| Popis: | Background: The bioactive cell-free formulation (BIOF2) for cartilage regeneration has shown a major therapeutic response in severe knee osteoarthritis. However, its effect on patients with mild or moderate stages of the disease has not been studied. Objective: To evaluate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, minimal clinically important improvement (MCII) and sleep disturbances in mild, moderate, and severe stages of knee osteoarthritis (OA) with the novel cell-free formulation treatment (BIOF2). Methods: An open-label, nonrandomized, baseline-controlled, parallel group study on patients with mild, moderate, and severe knee OA was conducted to evaluate the effect of intra-articular administration of BIOF2. Clinical improvement was determined through the WOMAC score and MCII, whereas sleep disturbances were measured through a Likert scale questionnaire. Results: At 6 months post-treatment, the mean decrease in the total WOMAC score was 16.4 +/- 4.7%, 49.9 +/- 6.4%, and 62.7 +/- 4.5% in the patients with mild, moderate, and severe disease, respectively ( p < 0.001, analysis of variance test). MCII at 6 months was 18%, 78%, and 100% for mild, moderate, and severe disease, respectively ( p < 0.001, likelihood-ratio χ 2 test). Concerning sleep disturbances, 60% of the patients with severe OA had important sleep problems before beginning treatment, and those difficulties were overcome 6 months after treatment. Only 18% of the patients with mild disease and 16% with moderate disease had serious sleep disturbances at the beginning of the study, and there was slight improvement after treatment. No adverse events were recorded during follow-up. Conclusion: BIOF2 generates better patient-reported health outcomes (on pain, stiffness, function, and sleep) in the more severe cases of knee OA. |
| Databáze: | OpenAIRE |
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