Magnetic resonance imaging analysis of the bioabsorbable Milagro (TM) interference screw for graft fixation in anterior cruciate ligament reconstruction

Ligament graft fixation with bioabsorbable interference screws is a standard procedure in cruciate ligament replacement. Previous screw designs may resorb incompletely, and can cause osteolysis and sterile cysts despite being implanted for several years. The aim of this study was to examine the in vivo degradation and biocompatibility of the new Milagro (TM) interference screw (Mitek, Norderstedt, Germany). The Milagro (TM) interference screw is made of 30% beta-TCP (TriCalcium phosphate) and 70% PLGA (Poly-lactic-co-glycolic acid). In the period between June 2005 and February 2006, 38 patients underwent graft fixation with Milagro (TM) screws in our hospital. Arthroscopic ACL reconstruction was performed using hamstring tendon grafts in all the patients. MR imaging was performed on 12 randomly selected patients out of the total of 38 at 3, 6 and 12 months after surgery. During the examination, the volume loss of the screw, tunnel enlargement, presence of osteolysis, fluid lines, edema and postoperative screw replacement by bone tissue were evaluated. There was no edema or signs of inflammation around the bone tunnels. At 3, 6 and 12 months, the tibial screws showed an average volume loss of 0, 8.1% (+/- 7.9%) and 82.6% (+/- 17.2%, P < 0.05), respectively. The femoral screws showed volume losses of 2.5% (+/- 2.1%), 31.3% (+/- 21.6%) and 92.02% (+/- 6.3%, P < 0.05), respectively. The femoral tunnel enlargement was 47.4% (+/- 43.8%) of the original bone tunnel volume after 12 months, and the mean tunnel volume of the tibial tunnel was -9.5% (+/- 58.1%) compared to the original tunnel. Bone ingrowth was observed in all the patients. In conclusion, the resorption behaviour of the Milagro (TM) screw is closely linked to the graft healing process. The screws were rapidly resorbed after 6 months and, at 12 months, only the screw remnants were detectable. Moreover, the Milagro (TM) screw is biocompatible and osteoconductive, promoting bone ingrowth during resorption. Tunnel enlargement is not prevented in the first months but is reduced by bone ingrowth after 12 months.