Polyurethane synthetic scaffold for meniscal regeneration: prospective clinical study at 3 years’ follow-up

Objectives: A new polyurethane meniscal scaffold has been introduced
in the clinical practice. The better properties compared to
previous devices should resist to the high knee forces and therefore
give more chondroprotection. Aim of this study is to evaluate its
safety and clinical efficacy to treat partial meniscal loss at 3 years’
follow-up.
Methods: 18 patients (11 males, 7 females, mean age 45 years)
affected by a partial loss of meniscal substance, either medial or
lateral (13 and 5, respectively), associated with pain and/or swelling
were treated with this implant and evaluated yearly up to 36 months.
Eleven patients also underwent concurrent procedures involving
cartilage treatment or osteotomies. One patient had a reinjury playing
competitive soccer after the 12 months evaluation and was excluded
from the subsequent analysis. Patients were prospectively evaluated
through IKDC objective and subjective, and Tegner scores. Furthermore,
MRI evaluation of the treated knees was performed.
Results: A statistically significant increase in all the clinical parameters
considered was registered. IKDC subjective score improved
from 47.3 ± 17.5 to 72.9 ± 13.9 (p\0.0005) at 1 year, result confirmed
at 2 and 3 years’ follow-up. The IKDC objective score
confirmed this trend, increasing from 61 % of normal/nearly normal
knees at basal evaluation to 94 % at 3 years of follow-up (p = 0.01).
Tegner score also showed a significant increase from the pre-operative
level (median value 2, range 1–5) to final evaluation (median
value 3, range 2–5; p = 0.005), albeit not reaching the pre-injury
level. MRI evaluation detected a good morphology but still present
hyper-intensity in all scaffolds.
Conclusions: The implantation of this novel polyurethane scaffold
proved to be safe and potentially effective for partial meniscal loss, with promising clinical and MRI results at short-term follow-up.
Further high-quality studies at longer follow-up could better evaluate
the clinical outcome and joint protection effect.