Treatment of subcapital femoral neck fractures with bioabsorbable or metallic screw fixation. A preliminary report.

BACKGROUND AND AIMS: Cancellous bone fractures and arthrodeses have been treated successfully with bioabsorbable polyglycolide and poly-L-lactide implants. In this study bioabsorbable poly-L-lactide lag screws and metallic screws were compared in the fixation of subcapital femoral neck fractures. PATIENTS AND METHODS: Forty patients with femoral neck fractures were treated by internal fixation using three bioabsorbable self-reinforced poly-L-lactide (SR-PLLA) lag screws of 6.3 mm in diameter and 38 patients using three metallic screws of 7 mm in diameter. In addition, one patient was operated on using two and one using four metallic screws. The patients did not differ in age, body weight or primary dislocation of the fracture. There were six males in the lactide group versus 14 in the metallic fixation group. There were two Garden Stage I, 27 Garden Stage II, nine Garden Stage III, and two Garden Stage IV fractures in both groups. RESULTS: In the Garden I and II fractures there were 5/29 redislocations after SR-PLLA fixation and 8/29 after metallic fixation. In the Garden III fractures there were 4/9 and in the Garden IV fractures 2/2 redislocations in both groups. The ability to walk and the range of movement were better after bioabsorbable fixation. CONCLUSION: Self-reinforced poly-L-lactide lag screws can be used safely to fix subcapital femoral neck fractures in Garden Stage I and II fractures and in younger patients in Garden III fractures.

Development of a bioabsorbable suture anchor.

In this article, the design and properties of a new bioabsorbable suture anchor (SmartAnchor(trade mark)) are described and its properties are compared with those of some commercial anchors. Two comparative experiments were carried out in order to measure (1) the breaking force of suture/anchor attachment for SmartAnchor, MitekGII, and for Ogden anchors; and (2) the fixation force of the following anchors and tacks: SmartAnchor, MitekGII, BankartTack, and Suretac. The average suture/anchor attachment breaking force of SmartAnchor (204, 9 N) was 32% higher in comparison to MitekGII (155, 6 N) and 84% higher in comparison to the Ogden anchor (111, 4). The mean fixation force of the SmartAnchor (195, 5 N) was 40% higher than that of MitekGII (139, 2 N), but the T-test showed no statistical differences between MitekGII and SmartAnchor (p = 0.05). Both tested tacks behaved very similarly in this test. The average fixation force (pull-out force) for both tacks was about 210 N. Therefore, it is evident that the bioabsorbable SmartAnchor has a high enough initial mechanical performance for clinical investigation.

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.

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.

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 Student's 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.

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.

[Absorbable rods and screws: a new method of fixation for fractures of the olecranon]. / Broches et vis biorésorbables: une nouvelle méthode de fixation des fractures de l'olécrâne. Etude clinique prospective sur 41 malades.

Between April 1986 and July 1990 fractures of the olecranon in 41 adult patients were treated by fixation with absorbable rods (20 patients) and screws (21 patients) of self-reinforced polyglycolide (SR-PGA), 3.2 mm in diameter and 20-70 mm in length. Patients were followed up for a mean time of 2 years 7 months (range 1 year to 4 years 6 months). After reduction of the fracture, channels were drilled from the proximal fragment through the cortex of the distal fragment and the fractures were fixed with absorbable rods or screws. By one year from follow-up maintenance of an anatomical reduction of the fracture was seen in 34 patients. Failure of fixation requiring a second operation occurred in 2 cases. In all cases functional recovery was at least satisfactory. Sinus formation as a sign of transient tissue reaction was observed in 3 cases, but did not influence the healing of the fractures or the functional recovery. The results in patients treated with rods or screws was similar. Absorbable screws combined with small rods and absorbable sutures allow treatment of +ore severe fractures of the olecranon than do rods alone.

The effect of a penetrating biodegradable implant on the growth plate. An experimental study on growing rabbits with special reference to polydioxanone.

This study examined the fate of a biodegradable polydioxanone (PDS) implant in growing bone in rabbits. In 20 immature rabbits, a PDS rod 2.0 mm in diameter and 25 mm in length was driven into a drill hole of equal bore in the intercondylar portion of the right femur across the central portion of the growth plate. In another 25 immature rabbits, a PDS rod 3.2 mm in diameter and 25 mm in length was driven into a corresponding drill hole using the same technique. The follow-up intervals were three, six, 12, 24, and 36 weeks. The distal femoral growth plates of both femora were analyzed by roentgenographic, microroentgenographic, oxytetracycline-fluorescence, histologic, and histomorphometric studies. Histomorphometric studies showed clear changes at the site of injury and appeared to be an excellent means of providing an exact numerical description of the different cellular areas of the growth plate in experimental studies. A transphyseal PDS implant 2.0 mm in diameter did not cause any permanent growth disturbance of the femur in a growing rabbit. An implant 3.2 mm in diameter caused a growth disturbance similar to a drill hole of equal bore.

Strength and strength retention in 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.