The study aimed to evaluate the short-term clinical effect, therapeutic response rate (TRR%), and therapy safety of a single intra-articular autologous MFAT injection for symptomatic knee OA. Secondly, patient- and pathology-related parameters were investigated to tighten patient selection for MFAT therapy. Sixty-four subjects with symptomatic mild–severe knee OA were enrolled in a single-center trial and received a unilateral (n = 37) or bilateral (n = 27) MFAT injection. After liposuction, the adipose tissue was mechanically processed with the Lipogem® device, which eventually produced 8–10 cc of MFAT. Subjects were clinically assessed by means of the KOOS, NRS, UCLA, and EQ-5D at baseline and 1, 3, 6, and 12 months after injection. Adverse events were recorded at each follow-up timepoint. The TRR was defined according to the OMERACT-OARSI criteria and baseline MRI was scored following the MOAKS classification. The TRR of the index knee was 64% at 3 months and 45% at 12 months after injection. Therapy responders at 12 months improved with 28.3 ± 11.4 on KOOS pain, while non-responders lost −2.1 ± 11.2 points. All clinical scores, except the UCLA, improved significantly at follow-up compared to baseline (p < 0.05). In the bilateral cohort, no difference in baseline scores or TRR was found between the index knee and contralateral knee (n.s.). An inflammatory reaction was reported in 79% of knees and resolved spontaneously within 16.6 ± 13.5 days after MFAT administration. Numerous bone marrow lesions (BML) were negatively correlated with the TRR at 12 months (p = 0.003). The study demonstrated an early clinical improvement but a mediocre response rate of 45% at 12 months after a single intra-articular injection with autologous MFAT. Assessment of bone marrow lesions on MRI can be helpful to increase the therapeutic responsiveness of MFAT up to 70% at 12 months. In comparison to repetitive injection therapies such as cortisone, hyaluronic acid, and PRP, administration of MFAT might become a relevant alternative in well-selected patients with symptomatic knee OA.

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PurposeThe study wanted to investigate the benefit, durability and safety of autologous protein solution (APS) injection(s) in a middle‐aged female‐only cohort suffering predominantly from patellofemoral osteoarthritis. MethodsFifty females (aged 50.4 ± 6.5) with mainly moderate–severe (86%) patellofemoral cartilage wear (PFCW) were treated with a unilateral intra‐articular APS injection. The KOOS, NRS, Kujala, UCLA and EQ‐5D were assessed at baseline and 1, 3, 6, and 12 months post‐injection. Therapeutic response rate (TRR) was based on KOOS pain improvement > 10 points. Absolute improvement for, respectively, therapy responders and non‐responders was determined. Second APS injection was administered if improvement was deemed insufficient by the patient after 3 months. ResultsThe TRR remained stable averaging to 53.7% at final follow‐up with subjects improving overall from 40.3 ± 18.7 to 57.3 ± 24.8 points on KOOS pain (p = 0.0002) and from 48.4 ± 13.0 to 56.3 ± 18.1 points on Kujala (p = 0.0203) at 12 months. Significant improvement was observed for the other KOOS subscales and NRS at each follow‐up. In absolute values, APS responders improved with 30.5 ± 11.4 points on KOOS pain at 12 months. In contrast, non‐responders deteriorated with 5.9 ± 8.9 points relative to baseline. A second APS injection was administered in 28 subjects. Patients with definite synovitis improved more on KOOS symptoms (p = 0.017) and KOOS ADL (p = 0.037) at 12 months compared to non‐synovitis subjects. Mild‐moderate arthralgia (46%) and effusion (29%) were commonly observed during the first month post‐injection. ConclusionThis study evidenced a 54% response rate at 12 months to a single or second APS injection in a middle‐aged female population with advanced patellofemoral cartilage wear. Moderate temporary flares can be expected without affecting clinical outcomes. Second APS injection has low efficacy in initially poor responding patients after 3 months. Major synovitis on baseline MRI appeared to be a beneficial prognosticator for pain relief and functional improvement after APS. Level of evidenceIV.

Objective The study aimed to evaluate the clinical outcome and repair capacity of a cell-free aragonite-based scaffold in patients with an isolated symptomatic joint surface lesion (JSL) of the knee. Design Thirteen patients (age 33.5 ± 8.9; female 23%; body mass index 25.3 ± 3.4, K/L [Kellgren-Lawrence] 1.8) with a JSL (2.6 ± 1.7 cm2 [1.0-7.5 cm2]) of the distal femur were enrolled in a single-center prospective case series. Safety and clinical outcome was assessed by the KOOS (Knee Injury and Osteoarthritis Outcome Score), IKDC (International Knee Documentation Committee), Lysholm, and Tegner activity scale at baseline and 6, 12, 18, 24, and 36 months follow-up. The MOCART 2.0 and scaffold integration were evaluated on magnetic resonance imaging at 12, 24, and 36 months postoperatively. Results Primary outcome (KOOS pain) improved with 36.5 ± 14.7 points at 12 months ( P = 0.002) and 41.2 ± 14.7 points at 36 months ( P = 0.002) follow-up. Similar increasing trends were observed for the other KOOS subscales, IKDC, and Lysholm score, which were significantly better at each follow-up time point relative to baseline ( P < 0.05). Activity level increased from 2.75 ± 1.6 to 4.6 ± 2.2 points at final follow-up ( P = 0.07). The MOCART was 61.7 ± 12.6 at 12 months and 72.9 ± 13.0 at 36 months postoperatively. Sixty-six to 100% implant integration and remodeling was observed in 73.3% cases at 36 months. No serious adverse events were reported. Conclusion The study demonstrated that the biphasic aragonite-based scaffold is a safe and clinically effective implant for treating small-medium sized JSLs of the distal femur in a young and active patient cohort. The implant showed satisfying osteointegration and restoration of the osteochondral unit up to 3 years postimplantation.