Gender-Specific Response in Pain and Function to Biologic Treatment of Knee Osteoarthritis: A Gender-Bias-Mitigated, Observational, Intention-to-Treat Study at Two Years

Abstract

Knee osteoarthritis is a major cause of disability worldwide. Newer modalities of treatment with less morbidity, such as intra-articular injection of microfragmented fat (MFAT), are showing promise. We report on our novel observation that women show a greater improvement in pain and function to MFAT than men. Traditionally, women have been underrepresented in studies and studies with both sexes regularly fail to analyze the results by sex. To mitigate for this bias and quantify it, we describe a technique using reproducible statistical analysis and replicable results with Open Access statistical software R to calculate the magnitude of this difference. Genetic, hormonal, environmental, and age factors play a role in our observed difference between the sexes. There is a need for further studies to identify the molecular basis for this difference and be able to utilize it to improve outcome for both women and men.

A gender-bias-mitigated, data-driven precision medicine system to assist in the selection of biological treatments of grade 3 and 4 knee osteoarthritis: development and preliminary validation of precisionKNEE

“…Our previous work has demonstrated the efficacy of MFAT in reducing the pain of knee OA at 1 year. We also quantified and mitigated the effect of gender bias observed in the outcomes [9] and went onto quantify the benefits achieved in a knee replacement population at 2 years [6]. The aim of this paper is to detail the process of generating an algorithm to predict the response of patients to the biological treatment of knee OA using MFAT.…”

“…The dataset used was generated from the biologic treatment of knee OA with MFAT [6], [7], [9] in 142 women and 187 men, correlating to 113980 datapoints. Variables considered were gender, age, body mass index, biological treatment type, aetiology of arthritic disease, radiological arthritic severity grade, pre-operative Oxford Knee Score and 1 year follow-up Oxford Knee Score (OKS).…”

“…The choice of the above subset of patients is driven by the overall aim of this research. This group of patients are deemed to be suitable for TKR [9]. Thus, we aim to assess if we can mitigate or delay the need for the current suboptimal standard-of-care.…”

Microfragmented Adipose Tissue Injection (MFAT) May Be a Solution to the Rationing of Total Knee Replacement: A Prospective, Gender-Bias Mitigated, Reproducible Analysis at Two Years

“…In women, age is the major influencing variable that affects the improvement in OKS following MFAT ( Figure 6 ), with little variation demonstrated in women in relation to BMI ( Figure 8 ). These gender differences may be due to a combination of genetic, metabolic, and endocrine factors [ 20 ].…”

“…Harvesting Adipose Tissue and Injecting MFAT. Full method for this technique has previously been described [20]. This injection is carried out as a day case procedure under sedation.…”