Pertti Helevirta

Strength and strength retention vitro, of absorbable, self-reinforced polyglycolide (PGA) rods for fracture fixation

The initial shear strength and changes in flexural strength of self-reinforced, absorbable polyglycolide (PGA) composite rods, submerged in distilled water (at 37 degrees C) for a period of 6 wk, were investigated. The recently developed self-reinforced absorbable material consists of an absorbable polymeric matrix reinforced with fibres of the same polymer. The initial shear strength of self-reinforced cylindrical PGA rods with a diameter of 3.2 mm was 250 MPa and the initial flexural strength of the rods was 370 MPa. During the first week of immersion the level of flexural strength decreased very little i.e. to 320 MPa. The loss of flexural strength increased after 1 wk immersion. However, after 3 wk it was 90 MPa. After 5 wk the flexural strength decreased to the level of strength of cancellous bone i.e. 10-20 MPa. The gamma-irradiation of the PGA rods (total dosage 2.5 Mrad) decreased the initial bending strength to 300 MPa but the hydrolytic behaviour of the rods was not changed. The in vitro strength and the strength retention of self-reinforced PGA rods are clearly better than the corresponding values for self-reinforced glycolide/lactide copolymer rods which we developed recently. Self-reinforced PGA rods are now used routinely in Helsinki University Central Hospital in the treatment of certain types of cancellous bone fracture.

SR-PLLA and SR-PGA miniscrews: biodegradation and tissue reactions in the calvarium and dura mater

The biocompatibility and degradation of self-reinforced poly-L-lactide (SR-PLLA) and polyglycolide (SR-PGA) miniscrews, vs titanium miniscrews, was studied in frontal bone osteotomies in 20 lambs, where they were used for plate fixation. At follow-up at 4, 6, 12, 26, 52 and 104 weeks, no clinical foreign body reaction, infection or other complications had occurred. Histologically, PGA material was hydrolyzed and fragmented at 4-6 weeks and was resorbed by 12 weeks, whereas the SR-PLLA miniscrews retained their integrity and holding power for 26 weeks and were mostly resorbed at 2 years. According to histological and histomorphometric analyses and plain film radiography, the degradation of PGA miniscrews was accompanied by a typical non-specific foreign-body reaction and initial transient osteolysis with decreased osteoid formation around the screw channel, but compensatory intense osteoid formation and bone remodelling followed after resorption of the polymer. The foreign body reactions to PLLA and titanium were considerably milder. All miniscrews were commendably strong and could be satisfactorily tightened against the plate. SR-PLLA miniscrews offer fixation stability for half a year, whereas rapidly degrading SR-PGA miniscrews may be used when short-term fixation is needed.

Strength retention of self-reinforced poly-L-lactide screws. A comparison of compression moulded and machine cut screws.

The effect of the manufacturing method on the strength retention of self-reinforced poly-L-lactide (SR-PLLA) screws was studied in vitro and in vivo from 3 up to at least 15 weeks. SR-PLLA screws were manufactured from axially oriented SR-PLLA billets by the conventional compression moulding process and an in-house developed machine cutting technique. New machined SR-PLLA screws (thread diameters 4.5 mm and 3.5 mm) were significantly stronger than older compression moulded SR-PLLA screws (4.5 mm and 3.5 mm) in bending and torque strength tests but significantly weaker in shear strength tests. In pull out tests there were not significant strength differences between the screws. Mechanical analysis and molecular weight measurements confirmed earlier observations that SR-PLLA degrades faster in vivo than in vitro. These results suggest that the new screws could be suitable for clinical use.

Strength of the fixation of patellar tendon bone grafts using a totally absorbable self-reinforced poly-L-lactide expansion plug and screw. An experimental study in a bovine cadaver

In a bovine cadaver study, bone-tendon-bone graft fixation strength with different graft geometry and fixation devices was measured to evaluate the fixation strength of totally absorbable implants: a 6.0-mm expansion plug and 6.3-mm screw both made of self-reinforced polylactide (SR-PLLA). Comparison was made with 6.5-mm AO cancellous screw. Maximum tensile force to dislodge the bone plug from the bone tunnel was recorded. First, two preliminary tests were performed. In the first test, triangular bone plugs were used (9-mm diameter). The direction of the pull force was parallel to the bone tunnel. The maximum tensile forces were 786 N in femoral insertions and 625 N in tibial insertions, mean. After this, we evaluated the influence of change in the pullout direction. In the second test, a circular bone plug was used with no fixation but the direction of the pull force was parallel to the tibial or femoral axis and the bone plug (10-mm diameter) was in a 30 degrees to 40 degrees angle to the direction of the pull force and it was compressed to the tunnel (9-mm diameter). The maximum tensile forces were 783 N in femoral insertions and 695 N in tibial insertions, mean. In the final third test, we used a curved saw in harvesting the graft. This made a half-circular bone block with a diameter of 12 mm. The maximum tensile force to dislodge the bone plug from the bone tunnel was recorded and the pull force was in a 30 degrees to 40 degrees angle to the tunnel. The results were evaluated with Students t-test and Mann-Whitney U-test. With the AO screw, the maximum tensile force to dislodge the bone plug from the bone tunnel was 2,113 +/- 407 N (mean +/- standard deviation) and it was better than the fixation strength of the SR-PLLA expansion plug, 1,379 +/- 328 N (P = .009, t-test) and better than the fixation strength of SR-PLLA screw, 1,454 +/- 230 N (P = .007, t-test). However, the maximum tensile force of both SR-PLLA implants in all measurements in the third test were above 1,100 N and it seems that the initial strength of totally absorbable implants is enough for the clinical use.

Comparison of polylactide screw and expansion bolt in bioabsorbable fixation with patellar tendon bone graft for anterior cruciate ligament rupture of the knee A preliminary study

Abstract In a preliminary study, 24 patients with rupture of the anterior cruciate ligament (ACL) were operated on using implants made of self-reinforced poly-l-lactide (SR-PLLA). The operation method was outside-in bone-tendon-bone reconstruction. In 10 patients the fixation was made with an SR-PLLA screw with a diameter of 6.3 mm, in 12 with an SR-PLLA expansion plug with a diameter of 6.0 mm, and in two cases both implants were used, but these cases were excluded from comparison. The purpose of the study was to evaluate and compare the use and fixation results of these two implants. The follow-up time averaged 3.2 years. Twenty patients attended follow-up. On subjective evaluations, seven of the eight patients following SR-PLLA screw fixation and six of the ten after expansion plug fixation regarded their knee as normal or nearly normal. Arthrometric testing showed the side-to-side difference to average 2.9 mm following SR-PLLA screw fixation and 2.6 mm after expansion plug fixation (NS). Six of the patients had giving-way symptoms (two after screw fixation and four after plug fixation). The pivot shift test was slightly positive in two patients and positive in one patient after SR-PLLA screw fixation, and in three knees slightly positive and in another three knees positive following expansion plug fixation. Radiography showed variation in the location and orientation of the bone channels. Magnetic resonance imaging was performed in seven cases, and in two cases an edema was found in the tendon of the anterior cruciate ligament graft and in six cases the implants were visible. No statistical difference in results between the SR-PLLA screw and SR-PLLA expansion bolt was noted. Fixation with expansion plug seems technically more challenging, with a tendency to inferior results compared to screw fixation. In the absorbable fixation of a bone-tendon-bone graft there are no metallic artifacts on magnetic resonance imaging and no need to remove the fixation material regarding the revision surgery.

Absorbable self-reinforced polyglycolide (SR-PGA) screws for the fixation of fractures and osteotomies: strength and strength retention in vitro and in vivo.

The initial mechanical strength and strength retention in vitro and in vivo of novel absorbable and self-reinforced polyglycolide (SR-PGA) screws for the fixation of fractures and osteotomies were determined. The SR-PGA screws showed initial bending strength values comparable with those of yield strength of standard stainless steel. The SR-PGA screws lost all their bending and shear strengths in 6 weeks in vivo. The strength retention properties of SR-PGA screws are sufficient for safe fixation of relatively rapidly consolidating fractures and osteotomies of cancellous bone that are not exposed to hard mechanical stresses.

Guided perichondrial proliferation with biodegradable, self-reinforced polyglycolic acid implants

The growth of neocartilage derived from perichondrium associated with self-reinforced polyglycolic acid (SR-PGA) implants was studied in ten rabbits. Free perichondrial grafts were taken from the dorsal side of the ear, wrapped and sutured around triangular SR-PGA plates, and implanted into the pectoralis muscles. As a control, a triangular perichondrial sac of the same size was shaped and implanted into the contralateral pectoralis muscles. Six weeks after operation neocartilage was found in each animal on both control and implant sides. The SR-PGA implants had guided the perichondrial potential to form triangular-shaped pieces of neocartilage, whereas the neocartilaginous plates on the control sides had lost their original shape.