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An Autologous Protein Solution Injection Reduces Knee Osteoarthritis Pain in a Randomized Saline-Controlled Study
ESSKA Academy. Kon E. May 11, 2018; 218123
Elizaveta Kon
Elizaveta Kon
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Abstract
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Objectives: Osteoarthritis (OA) is a debilitating disease resulting in substantial pain and functional limitations. A novel blood derivative has been developed to concentrate both growth factors and antagonists of inflammatory cytokines, with promising preliminary findings in terms of safety profile and clinical improvement. Aim of this study was to investigate if one intraarticular injection of Autologous Protein Solution (APS) can reduce pain and improve function in patients affected by knee OA in a multicenter, randomized, double-blind, saline-controlled study.

Methods: Forty-six patients with unilateral knee OA (Kellgren-Lawrence 2 or 3) were randomized into Group 1 (31), which received a single ultrasound-guided injection of APS, and Group 2 (15), which received a single saline injection. Patient reported outcomes and adverse events were collected at 2 weeks, 1, 3, 6, and 12 months through VAS, WOMAC, KOOS, SF-36, CGI-S/C, PGI-S/C scores and OMERACT-OARSI responder rate. Imaging evaluation was also performed with X-Ray and MRI before and after the treatment (12m, and 3 and 12m, respectively).

Results: The safety profile was positive, with no significant differences in frequency and severity of adverse events between groups. No procedure- or device-related serious adverse events were reported. The change from baseline to 12 months in WOMAC pain score was 65% in Group 1 and 41% in Group 2 (p=0.02). Additionally, VAS pain improvement was 49% in Group 1 and 13% in Group 2 (p=0.06). At 12 Months, APS showed better SF-36 subscales Bodily Pain (p=0.0085) and Role Emotional Health (p=0.0410), and CGI-C values (p=0.01). Significant differences between groups were detected in change from baseline to 12 months in bone marrow lesion size and osteophytes in the central zone of the lateral femoral condyle, both in favor of the APS group (p=0.041 and p=0.032, respectively).

Conclusions: This study provides evidence to support the safety and clinical effectiveness of a single intra-articular injection of APS in patients affected by knee OA. The clinical improvement was stable at the last evaluation, thus suggesting a longer lasting effect that should be quantified by future long-term studies.

Keywords:
APS, knee, osteoarthritis
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