Autologous microfragmented adipose tissue and leukocyte-poor platelet-rich plasma combined with hyaluronic acid show comparable clinical outcomes for symptomatic early knee osteoarthritis over a two-year follow-up period: a prospective randomized clinical trial

Abstract

Purpose The purpose of this prospective randomized clinical trial is to compare the clinical outcomes of three injections of leucocyte-poor platelet-rich plasma (LP-PRP) and hyaluronic acid (HA) to a single dose of autologous microfragmented adipose tissue (AMAT) in patients with mild osteoarthritis at a two-year follow-up. Methods Eighty symptomatic knees in fifty patients (mean age: 62.38 ± 11.88 years) with Kellgren-Lawrence grade 0 to 2 osteoarthritis were non blinded, randomly allocated into two equal groups. Group 1 consisted of 40 knees that received autologous LP-PRP + HA; Group 2 consisted of 40 knees treated with a single dose of AMAT injection. The outcomes were measured by Tegner, Marx, Visual Analogue Scale (VAS) for pain, International Knee Documentation Committee, and Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 (T1), 12 (T2), and 24 (T3) months. Adverse events were recorded at each follow-up timepoint. To assess score differences among subjects of the same gender and age, a subgroup analysis was performed. Results Both groups had significant clinical and functional improvement at 6, 12, and 24 months (p < 0.05). Comparing the two groups, the AMAT groups showed significantly higher pre-operative Marx score (3.35 ± 4.91 vs. 1.78 ± 3.91) and VAS score (5.03 ± 2.02 vs. 3.85 ± 1.68) (p < 0.05), higher VAS (3.89 ± 2.51 vs. 2.64 ± 2.00) at T2 and KOOS-ADL (79.60 ± 20.20 vs. 65.68 ± 23.62), and lower KOOS-Sports (50.30 ± 30.15 vs. 68.35 ± 30.39) at T3 (p < 0.05). No patient from either group had experienced major adverse effects. In the LP-PRP group 12 (30%) patients presented swelling, redness, and mild pain for one day after injection and two patients had synovitis for two days and required paracetamol and local ice. In AMAT group 5 (12.5%) patients had ecchymosis and bruising at the fat aspiration site for three days. Conclusion AMAT did not show significant superior clinical improvement compared with three LP-PRP combined with HA injections in terms of functional improvement at different follow-up points. Both procedures were safe with no major complications reporting good results at mid-term follow-up, improving knee function, pain, and quality of live regardless of age and gender. Level of evidence Level I—Prospective Randomized Clinical Trial.

Autologous micro‐fragmented adipose tissue injection provides significant and prolonged clinical improvement in patients with knee osteoarthritis: a case‐series study

“…Gobbi et al performed a Randomized Clinical Trial comparing MAT with leukocyte-poor platelet-rich plasma plus hyaluronic acid with a 2 years follow-up. They showed that both treatments lead to significant clinical improvement without a relevant difference between each other within a cohort of patients with KL grades 1-2 [40] with an improvement in KOOS score in line with the results of this research.…”

Adipose Tissue-Derived Minimally Manipulated Products versus Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Systematic Review of Clinical Evidence and Meta-Analysis

“…Patients lost at the final follow-up were 51 for MM-AT and 23 for control groups. Thirteen studies injected MM-AT bilaterally in some patients [ 30 , 32 , 33 , 35 , 36 , 37 , 38 , 41 , 43 , 45 , 46 , 47 , 53 , 54 , 56 , 58 ] and, among them, in one study the treatment was bilateral in all patients [ 58 ]. The ratio between males and females was 1.0 in the MM-AT group and 1.4 for the control groups.…”

“…The mean BMI went from 24.7 [ 50 ] to > 35 [ 40 ] for MM-AT and from 26.0 [ 42 ] to 31.0 [ 29 ] for the control groups (12 studies did not report BMI). Patients presented different OA grades, often measured with KL classification: nine studies on KL 1–4 [ 28 , 29 , 39 , 44 , 45 , 46 , 54 , 56 , 59 ], eight studies on KL 3–4 [ 30 , 33 , 35 , 40 , 41 , 47 , 48 , 55 ], three studies on KL 2–3 [ 34 , 42 , 50 ], three studies on KL 1–3 [ 34 , 44 , 51 ], two studies on KL 1–2 [ 32 , 37 ], and two studies on KL 2–4 [ 36 , 53 ]. In addition, patients with mild, moderate, or severe OA grade [ 43 ], ICRS grade of 2–4 [ 51 , 52 ], and American College of Rheumatology criteria 1–3 [ 57 ] were also evaluated.…”

“…MM-AT injection was compared with other orthobiologic treatments, such as PRP (n = 5) [ 29 , 32 , 37 , 42 , 59 ] and BMAC (n = 2) [ 45 , 49 ]. Moreover, the augmentation of intra-articular MM-AT injections to surgical procedures was evaluated in three studies: augmentation to arthroscopic debridement (AD) (n = 2) [ 48 , 55 ] and augmentation to high tibial osteotomy (HTO) (n = 1) [ 44 ].…”

Bio-Orthopedics: A New Approach to Osteoarthritis and Joint Disorders

“…Promising results have been shown in literature. In multi-centric, international, open-label study evaluating the outcomes of MFAT injections in patients with knee OA at 2-year follow-up significant functional and quality of life improvement was seen in 88% of patients [23]. In a prospective randomized control trial comparing leukocyte-poor PRP combined with HA and MFAT no significant superiority was seen for either group, both procedures were found to be safe with no major complications showing good results at mid-term follow-up [24].…”