Control of material stiffness during degradation for constructs made of absorbable polymer fibers

Augmentation devices for cruciate ligament surgery should provide gradually decreasing mechanical properties with a half-time strength of at least 6 months to temporarily protect healing tendon grafts or sutured ligaments against high tensile loads during the postoperative healing period. The absorbable material of choice that shows such slow degradation kinetics is poly(L-lactide). However, previous studies have shown that poly(L-lactide) fulfills the requirement of a long half-time strength, while the corresponding stiffness decreases at a much slower rate. An augmentation stiffness that does not change much versus time cannot provide a gradual increase in graft load, which is important to stimulate the orientation of the collagenous tissue. Therefore a new augmentation device was designed, which should decrease both in strength and stiffness during degradation. The cord was braided out of two fibers made of poly(L-lactide) and poly(L-lactide-co-glycolide), which degrade at different rates. The cord prototype was degraded in vitro and the rupture force and stiffness was tested at eight different time points up to 60 weeks. The initial rupture force and stiffness was 522.7 +/- 2.8 N and 104.1 +/- 3.8 N/%, respectively. Both strength and stiffness decreased continuously with a half-time strength of 18 weeks and a half-time stiffness of 39 weeks. The gradually decreasing stiffness was achieved by the breakdown of the faster-degrading fiber component made of poly(L-lactide-co-glycolide). Thus the new augmentation device can provide a continuous increase of forces in a tendon graft or in a healing ligament.