| Autor: |
Olufade O; Department of Orthopedics, Emory University, Atlanta, GA 30329, USA.; Department of Physical Medicine & Rehabilitation, Emory University, Atlanta, GA 30307, USA., Negron G; Department of Physical Medicine & Rehabilitation, Emory University, Atlanta, GA 30307, USA., Berrigan W; Department of Orthopedics, Emory University, Atlanta, GA 30329, USA., Sirutis B; Department of Physical Medicine & Rehabilitation, Emory University, Atlanta, GA 30307, USA., Whitley J; Department of Orthopedics, Emory University, Atlanta, GA 30329, USA., Easley K; Department of Biostatistics & Bioinformatics, Rollins School of Public Health Emory University, Atlanta, GA 30329, USA., Chen Y; Department of Biostatistics & Bioinformatics, Rollins School of Public Health Emory University, Atlanta, GA 30329, USA., Mautner K; Department of Orthopedics, Emory University, Atlanta, GA 30329, USA.; Department of Physical Medicine & Rehabilitation, Emory University, Atlanta, GA 30307, USA. |
| Abstrakt: |
Objectives: The purpose is to report preliminary data on clinical response to dehydrated cell and protein concentrate (dCPC) versus corticosteroid (CSI). Design: A single-site prospective, randomized controlled single-blinded trial of patients with knee osteoarthritis. Methods : Pain and function were assessed using a visual analog scale (VAS), the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Emory Quality of Life (EQOL) measure at 1, 2, 3, 6, 9 and 12 months. Results: 51 patients were enrolled at the time of analysis (27 dCPC, 24 CSI). Both groups demonstrated improvement on the VAS, KOOS and EQOL. Largest differences were observed at 2 (p = 0.05), 3 (p = 0.012) and 6 months (p < 0.001) with a decrease of 1.66 in VAS at 6 months for dCPC (95% CI: -2.67 to -0.65) and 1.34 (95% CI: -2.37 to -0.3) for CSI. Time-averaged measures showed no difference between groups (p = 0.20). Limited data at 9 and 12 months trended toward improvement in the dCPC group. Conclusion: dCPC products may be used as a treatment for knee osteoarthritis. Larger trials are warranted. Clinical Trial Registration: NCT03710005 (ClinicalTrials.gov). |
