Mechanical and biological properties of the GORE-TEX expanded polytetrafluoroethylene (PTFE) prosthetic ligament.

Data from these studies have resulted in a modified implant technique which has taken into consideration the salient points from this and previous studies. Ongoing animal studies will provide a better understanding of the long-term performance of the material in the anterior cruciate ligament and medial collateral ligament positions. Additional studies will be implemented as new techniques and applications evolve. The key conclusions of this study are as follows: 1. This prosthetic ligament system is not intended to match the mechanical properties of the normal anterior cruciate ligament in dogs. However, in the dog at one to four months the GORE-TEX Prosthetic Ligament system is at least comparable in tensile strength to the repaired anterior cruciate ligament utilizing autogenous tissue at eight months. 2. One square knot with wire augmentation, appears to be an adequate method of fixation; however, since proximal placement of the knot will result in a mild bursitis formation, the implant technique has been modified so that the knot is placed more distally under the cranial tibial muscle. 3. The porosity of the material is adequate to allow for the tissue ingrowth, which is essential for fixation augmentation. 4. The recommended method of implantation appears to be crucial to satisfactory long-term performance of the device. Of particular importance, all edges of drill holes must be thoroughly radiused in order to minimize stress concentrations. 5. The GORE-TEX Prosthetic Ligament implanted in the anterior cruciate ligament position was effective in maintaining joint stability in the dog for up to four months. Ongoing studies have demonstrated maintenance of joint stability for up to ten months. 6. The limb need not be immobilized in order to assure healing and adequate fixation of the device. The immediate relative stability produced by the GORE-TEX Prosthetic Ligament system is adequate to encourage early mobilization. The only protection required is to allow soft tissue healing and initial tissue attachment to the graft material.