Abstract
PurposeThe increasing awareness on the role of subchondral bone in the etiopathology of articular surface lesions led to the development of osteochondral scaffolds. While safety and promising results have been suggested, there are no trials proving the real potential of the osteochondral regenerative approach. Aim was to assess the benefit provided by a nanostructured collagen–hydroxyapatite (coll-HA) multilayer scaffold for the treatment of chondral and osteochondral knee lesions.MethodsIn this multicentre randomized controlled clinical trial, 100 patients affected by symptomatic chondral and osteochondral lesions were treated and evaluated for up to 2 years (51 study group and 49 control group). A biomimetic coll-HA scaffold was studied, and bone marrow stimulation (BMS) was used as reference intervention. Primary efficacy measurement was IKDC subjective score at 2 years. Secondary efficacy measurements were: KOOS, IKDC Knee Examination Form, Tegner and VAS Pain scores evaluated at 6, 12 and 24 months. Tissue regeneration was evaluated with MRI MOCART scoring system at 6, 12 and 24 months. An external independent agency was involved to ensure data correctness and objectiveness.ResultsA statistically significant improvement of all clinical scores was obtained from basal evaluation to 2-year follow-up in both groups, although no overall statistically significant differences were detected between the two treatments. Conversely, the subgroup of patients affected by deep osteochondral lesions (i.e. Outerbridge grade IV and OCD) showed a statistically significant better IKDC subjective outcome (+12.4 points, p = 0.036) in the coll-HA group. Statistically significant better results were also found for another challenging group: sport active patients (+16.0, p = 0.027). Severe adverse events related to treatment were documented only in three patients in the coll-HA group and in one in the BMS group. The MOCART score showed no statistical difference between the two groups.ConclusionsThis study highlighted the safety and potential of a biomimetic implant. While no statistically significant differences were found compared to BMS for chondral lesions, this procedure can be considered a suitable option for the treatment of osteochondral lesions.Level of evidenceI.
Highlights
Chondral and osteochondral lesions are debilitating conditions that, if not properly treated, may lead to the development of osteoarthritis, with a high impact on patients and society, both in terms of healthcare and workforce loss [14, 15]
MF is a bone marrow stimulation (BMS) technique aimed at recruiting bone marrow cells by creating a communication between cartilage lesions and subchondral bone, allowing stem cells to migrate to the fibrin clot of the defect and form a fibrocartilaginous repair tissue [36]
Patients affected by deep osteochondral lesions with no associated ACL surgery were identified as group of interest. This subgroup included 27 patients treated with coll-HA and 30 with BMS; the analysis showed statistically higher values in terms of adjusted means of changes from baseline to 2 years: 33.6 for coll-HA vs 21.2 for the BMS group at 2 years of follow-up
Summary
Chondral and osteochondral lesions are debilitating conditions that, if not properly treated, may lead to the development of osteoarthritis, with a high impact on patients and society, both in terms of healthcare and workforce loss [14, 15]. In the attempt to fulfil patients’ expectations and successfully treat this pathology, several techniques have been developed over the years [26]. MF is a bone marrow stimulation (BMS) technique aimed at recruiting bone marrow cells by creating a communication between cartilage lesions and subchondral bone, allowing stem cells to migrate to the fibrin clot of the defect and form a fibrocartilaginous repair tissue [36]. Regenerative procedures aim at recreating a hyaline-like tissue as similar as possible to the physiological one, and they are emerging as a potential therapeutic option in cases of large lesions, where other procedures are less indicated [1, 32]. Despite the increasing number of publications every year confirming good outcomes at midterm evaluations [1], the superiority of this technique versus BMS has not been clearly proven, and MF is still considered the gold standard that sets the reference point to measure the potential of new procedures [8]
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