Biocompatibility of polyethylene terephthalate (Trevira hochfest) augmentation device in repair of the anterior cruciate ligament.

The biocompatibility of a 3 mm band made of polyethylene terephthalate (Trevira hochfest) has been tested in an experimental study within right knee joints of 60 sheep. After transsecting the anterior cruciate ligament (ACL), two randomized groups were formed. In group I, the ACL was repaired according to the Marshall technique whilst in group II an additional 3 mm polyethylene terephthalate (PET) augmentation band was implanted using the through-the-condyle (TTC) procedure. To assess the biocompatibility of the augmentation device the knee joints of both groups were punctured and the synovial fluids were analyzed before, as well as 2, 6, 16, 26, and 52 weeks after the operation. In addition, the histologic appearance of excised suprapatellar pouches and ipsilateral inguinal and popliteal lymphatic noduli were examined. Comparing both groups no significant differences were found neither before nor after the augmented and non-augmented ACL repair. No pathological increase in the total protein concentration occurred after operation and no significant differences versus the preoperative analysis were found. No synovitis signalling a decrease in the glucose concentration was observed. The cytological examination revealed no increase of the leukocyte cell count results. Within the synovial specimen neither free nor phagocytosed PET wearparticles could be detected. In groups I and II the histological appearance of excised popliteal and inguinal lymphatic noduli showed a normal result. In 25% of the PET augmented ACL repairs, a slight concentration of PET wearparticles and solitary, multinuclear giant foreign body cells could be seen in the histological preparations of suprapatellar pouches.

RCT Entities:   Population Interventions Outcomes