Background: Multilayered osteochondral scaffolds, either stand-alone or biologically augmented with cells, are becoming increasingly utilized for the repair of joint surface lesions in the knee (KJSL). However, the literature is rather limited about the potential factors that predict the treatment outcomes.
Purpose: 1) To analyse the impact of patients’ intrinsic and knee factors on preoperative subjective status, functioning and quality of life. 2) To evaluate clinical outcomes and safety of a combined single-step approach with a biomimetic collagen-hydroxyapatite scaffold (CHAS) (MaioRegen®, by Finceramica, Italy) and filtered Bone Marrow Aspirate (fBMA) in the treatment of KJSL. 3) To identify predicting factors for the postoperative improvements and safety, including the patients’ demographics and history, joint status, surgical details, and fBMA cellular components.
Methods: All the patients operated on due to KJSL (size ≥ 1.5 cm2, ICRS grades III-IV) by the combination above were prospectively included in the hospital registry database (100 patients). Their treatment outcomes were followed clinically (KOOS, EQ-5D, Tegner activity scale - TAS) and by pursuing serious adverse events (SAE) and graft failures (GF). Patients’ demographics, medical history, knee joint and lesion status, intraoperative details, and cellular parameters of the injected fBMA were determined. The arthroscopic evaluation of chondral and meniscal tissue quality in all knee compartments with Chondropenia Severity Score (CSS) was introduced for the first time in such type of studies. Pre- and postoperative PROMs values were compared to evaluate postoperative improvements. Multivariable regression models were utilized to identify significant predictors of preoperative status, treatment outcomes and safety.
Results: Older patients, females and those, who underwent previous surgeries, were more affected by KJSL. At the mean follow-up of 54.2 ± 19.4 months, 78 (87 %) patients returned their questionnaires with significant improvements toward the baseline (p < 0,00625): KOOS subscale Pain from 62 (17) to 79 (18), KOOS Total Score from 57 (16) to 70 (20), EQ-VAS from 61 (21) to 76 (16), EQ-5D-3L from 0,57 (0,20) to 0,80 (0,21), and TAS from 2,8 (1,5) to 3,9 (1,9). The GF rate was 4 %. Longer preoperative symptoms’ duration, previous surgeries, larger lesions, older age, and female sex were the main negative predictors for the postoperative outcomes. CSS and the number of fibroblast colony forming units (CFU-F) in fBMA had positively influenced some of the clinical results and safety.
Conclusions: CHAS augmented with fBMA proved as an adequate and safe approach for KJSL treatment up to mid-term follow-up. Based on the sub analysis of predicting factors, the surgical intervention should be performed in a timely and precise manner to prevent the lesion enlargement, the deterioration of general knee cartilage status, and to avoid recurrent surgeries, especially in older and female patients. When using autologous mesenchymal stem stromal cells (MSC) augmentation to CHAS, “the more, the better” principle should be followed.
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