2015 ISAKOS Biennial Congress ePoster #1517

Synthetic Polymer Scaffolds Vs Microfracture: Three Year Follow-Up Prospective Randomised Trial

Gianluca Camillieri, MD, Mazzano Romano ITALY
Vittorio Calvisi, MD, L'Aquila ITALY

University of L'Aquila, L'Aquila, ITALY

FDA Status Not Applicable

Summary: Synthetic polymer scaffolds are widely used for cartilage or osteochondral repair. Too many products are launched on the market without aduquate trials. The present study confirms this sentence.

ePoster Not Provided
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Abstract:

Objective

To evaluate the clinical outcome and MRI findings of synthetic resorbable biphasic implant (TruFit Plug; Smith & Nephew, San Antonio, TX) that immediately fill a chondral or osteochondral defect vs microfracture at 6 months, one, two and three years follow-up. METHODS: 36 consecutive patients were included in the study, randomized in two groups and evaluated clinically using the Cartilage Standard Evaluation Form as proposed by ICRS and the Tegner score. For the description and evaluation of MRI findings, we employed the MOCART-scoring system. SPSS software was used for statistical analysis. Limit of confidence was set at p<0.05. RESULTS: A statistically significant improvement in all clinical scores was observed at 1 year in both groups. At two years follow-up the TruFit group didn’t show better clinical results than microfracture group. Actually, at two and three years follow-up, both groups showed decreased clinical and MRI scores than one year follow-up. The total MOCART score and the signal intensity of the repair tissue were statistically correlated to the IKDC subjective evaluation. Any correlation between size and position of the treated cartilage lesions, with clinical outcomes and MRI findings were found regarding to TruFit Plug. Nine implants showed a delayed incorporation into the bone (MRI evaluation). Four of them had worse clinical outcomes. Second look arthroscopy was performed in eight patients (5 TruFit, 3 Microfracture). CONCLUSION: Microfractures and TruFit gave a temporary improvement during the first year after surgery, with a progressive worsening at two and three years FU. MRI (MOCART score) is a reliable method to evaluate the integration and evolution of cartilage procedures showing the same worsening behaviour of the clinical outcome at two and three years FU. Longer FU and further studies are necessary to confirm the impact of synthetic scaffolds on cartilage and osteochondral repair.