Abstract
Background:
Different surgical approaches have been proposed for the treatment of chondral lesions. However surgical management of osteochondral defects of the knee joint involving subchondral bone are still under debate.
Purpose:
The aim of this prospective non-randomized uncontrolled clinical investigation is to confirm the effectiveness of a commercially available biomimetic osteochondral scaffold in regenerating cartilage and subchondral bone of severe osteochondral lesions of the knee joint with one step surgery.
Methods:
The biomimetic scaffold has a multilayer structure consisting of a combination of type I collagen and type I collagen/hydroxyapatite, mimicking the osteochondral connective tissue of the knee joint. From 2009 to 2011, sixty-one patients affected by grade III or IV osteochondral lesions of the knee, according to Outerbridge Classification, were admitted to three centers and received the biomimetic scaffold. Four-nine patients were evaluated using the International Knee Documentation Committee (IKDC), Tegner and VAS scores, and MRI at 1-, 2- and 3-year follow-ups. Biopsies were carried out in 5 patients at an average time of 19.2 months to histologically evaluate the quality of the newly-formed tissue.
Results:
All patients tolerated the surgery well; no major adverse events were observed in the early postoperative period. Clinical evaluation of the 49 patients showed a statistically significant improvement in all scores at 1- 2- and 3-year follow-ups as compared to preoperative baseline scores. Improvement in the scores and functional recovery seemed to reach a plateau after 2 years; no significant improvement was seen between the 2- and the 3-year follow-up.
Conclusions:
A synthetic biomimetic scaffold used in one-step surgery for the treatment of severe osteochondral knee lesions significantly improved symptoms and joint function, as demonstrated by subjective and objective scoring system evaluation. Furthermore, the athletic subpopulation exhibited a significantly better outcome than the non-athletic subpopulation.
