Safety and Efficacy of a Novel Polyglycolic Acid Meniscal Scaffold for Irreparable Meniscal Tear
Shuhei Otsuki, Shunsuke Sezaki, Yoshinori Okamoto, Takashi Ishitani, Hitoshi Wakama, Masashi Neo- Physical Therapy, Sports Therapy and Rehabilitation
- Biomedical Engineering
- Immunology and Allergy
Objective
Meniscal tears treated with a partial meniscectomy could induce knee osteoarthritis, thereby altering or damaging knee kinetics and biomechanics. We have developed a meniscal scaffold made of polyglycolic acid (PGA) coated with polylactic acid/caprolactone (PGA scaffold), which could induce new tissue growth of meniscus-like tissue. This study aimed to evaluate the safety and efficacy of a novel meniscal scaffold for the treatment of irreparable meniscal injuries.
Design
This study describes the findings of a cyclic torque test and first clinical trial of a PGA scaffold for inducing meniscus-like tissue in humans. As the first step, biomechanical testing of the PGA scaffold was performed using a cyclic torque test. Six patients underwent arthroscopic implantation of the PGA scaffold. Furthermore, the patients underwent preoperative clinical, serological, radiographic, and magnetic resonance imaging examinations at 3, 6, and 12 months postoperatively. The patients also underwent a second-look arthroscopy 12 months after implantation.
Results
Torque increased with increasing cyclic loading. However, no structural damage to the sample was noted after 70,000 loading cycles. All patients showed improvement in pain, Lysholm scores, Tegner activity scores, International Knee Documentation Committee, and knee injury and osteoarthritis outcome. The second-look arthroscopy revealed that meniscal tissue had regenerated in 5 patients (83%). Radiography and magnetic resonance imaging confirmed no progression of degenerative joint disease.
Conclusions
The PGA scaffold could tolerate shear forces, did not produce safety concerns, and may have therapeutic potentials for irreparable meniscal tears in humans.