Summary

The novel meniscal scaffold might have new therapeutic potential for irreparable meniscal tear from human clinical trial.

Abstract

Background

Meniscal tear treated with partial meniscectomy induces knee osteoarthritis. Therefore, attempts to restoring normal knee kinematics and biomechanical forces are essential. Because prosthetic replacement of the meniscus has proven ineffective, we had established meniscal scaffold made by Polyglycolic acid (PGA) coated with polylactic acid/caprolactone, (PGA scaffold) that supports ingrowth of new tissue and eventual regeneration of the lost meniscus.

Purpose

To evaluate the effect of a novel meniscal scaffold for the treatment of irreparable meniscal injury.
Study Design: Human clinical trial

Methods

Six patients underwent arthroscopic implantation of the PGA scaffold to reconstruct and restore the irreparably damaged meniscus of the knee. Five patients had detected irreparable degeneration at medial meniscus, and one patient had received prior meniscectomies at lateral meniscus. Patients were observed with frequent clinical, and radiographic examinations at preoperative, 3, 6 and 12 months postoperatively, and all patients underwent second-look arthroscopy at 12 months after implantation. Magnetic resonance imaging (MRI) was evaluated until postoperative 2 years.

Results

Second-look arthroscopy revealed that meniscal like tissue was regenerated in five of the six patients, while one patient of implanted scaffold had been absorbed. In terms of the clinical trial, five patients who detected meniscal like tissue, had improved from preoperatively to postoperative 2 years (67.8 to 95.6 of Lysholm, and 48.7 to 86.1 of IKDC scores). On the other hand, one patient who absorbed meniscal scaffold, had shown lower IKDC of 69 points in comparison with the average of 86 points of other five patients. Radiographs in all patients had confirmed no progression of degenerative joint disease. Moreover, some patients had improved horizontal degenerative tear and the patients after meniscectomy had increased the size of meniscus like tissue with MRI findings at 2-year follow-up.

Conclusion

The novel meniscal PGA scaffold implantation might have new therapeutic potential for irreparable meniscal tear from human clinical trial.