Purpose: The 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.
Methods: Fifty 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.
Results: The 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.
Conclusion: This 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 evidence: IV.
Keywords: Biological; Conservative; Female; Injection; Joint preservation; Knee; Osteoarthritis; Patellofemoral; Therapy.