Background

Safety and efficacy of novel prostheses relies on the determination of early implant migration and subsequent risk of loosening. Radiostereometric Analysis (RSA) has been used to evaluate the clinical failure risks of femoral stems by reporting distal migration, a measure of stem subsidence, when examining early migration characteristics. The migratory patterns of femoral stems, 24 months postoperatively, have provided a surrogate outcome measure to determine implant stabilisation and predict long-term performance and survivorship. RSA assessed femoral stem migration and provided comparison of the early migration characteristics with published data of a clinically established counterpart.

Introduction and Aims: Mobile bearings have been introduced in total knee arthroplasty (TKA) as a means to improve kinematics and reduce wear. Another theoretical advantage may be a reduction of the torsional and shear stresses at the baseplate – bone interface, and thereby improving the fixation of the tibial component. The aim of this study was to analyse and compare the fixation of tibial components with fixed or mobile bearings in a prospective randomised study using RSA.

Method: Fifty-two consecutive patients (31 women, 21 men, mean age 72) with knee osteoarthrosis underwent primary cemented total knee arthroplasty. Included were patients with arthrosis stage III–V and age over 62. Patients were randomised at operation by opening of sealed envelopes to either Mobile Bearing (MB) or Fixed Bearing (FB). The FB knees received a NexGen TKA with titanium tibial baseplate, and the MB knees a NexGen mobile bearing TKA with CrCo tibial baseplate. All components were cemented using vacuum-mixed Palacos-Gentamicin bone cement. The stem of the component was not cemented. Patellar components were not used. Each tibial baseplate was equipped with five tantalum markers on the undersurface by the manufacturer. The peri- and post-operative management was in all cases identical. Radiostereometric analysis (RSA) was performed three, 12, and 24 months post-op. Clinical results were assessed with Knee Society Knee and Function Scores.

Results: There were no complications. One patient (MB) died two months after operation in myocardial infarction. The Knee Society Knee and Function scores and range of knee motion improved after surgery in both groups with no differences between the groups, reaching 89 at both 12 and 24 months. The rotations of the tibial baseplates did not differ significantly between the two groups. In both groups, anterior-posterior tilting was somewhat larger than varus-valgus tilting. Maximum subsidence was 0.3 ± 0.1 mm (MB) and 0.2 ± 0.1 mm (FB), and maximum migration was 0.6 ± 0.2 mm (MB) and 0.5 ± 0.1 mm (FB) (P = 0.3 – 0.4).

Conclusion: This study could not detect any positive effects on the fixation of the cemented tibial baseplate when a mobile polyethylene insert was used. It may be that in cemented fixation the theoretical advantages of lower shearing and torsional forces at the interface are not important, at least during the initial 24 months post-op.

Introduction: Uncemented press fit cups function well in the medium term, but often seem to develop backside osteolysis in the long term. This study was done to compare migration and osteolysis for cups with different fixation to find out if augmentation is needed or more a risk factor.

Method: Eighty seven hips in 81 patients planned for a THA due to OA were randomised and operated with a Reflection cup inserted with under reaming and press fit. Group 1 had a porous coated cup without holes; group 2 had the same cup with additional HA coating. Group 3 had a porous coated cup with six holes and fixed with three screws; and group 4 an identical cup fixed with three pegs. Early cup stability, migration, osteolysis and function were followed over five years with RSA, x- rays and Harris hip score and the groups compared statistically.

Results: At five years the mean (SD) translation for all cups was 0.13 (0.28) mm proximally, 0.002 (0.41) mm medially, and 0.13 (0.42) mm anteriorly. The inclination increased 0.13 degrees (0.84 degrees), anteversion 0.13 degrees (0.84 degrees), and anterior tilt 0.15 degrees (0.92 degrees). There were no differences in migration between the four modes of fixation (p=0.053–0.9). An inducible displacement test of stability one week after operation showed only minor movements, below the detection limit for RSA and without group differences. Thirty-five cups had a central gap post-operatively, all disappeared within two years and did not imply either inferior fixation or radiolucencies. The HA-coated cups displayed less radiolucent lines (p=0.003) than the other groups when measured as percentage of the total interface. Most lucent lines were seen in zones 2 and 3 and developed during the initial two years. At five years, minor focal osteolytic lesions were found in 13 hips, most in cups with screws and all progressing slowly. The proximal wear was 1.02mm and the 3D wear 1.05 mm after five years, equal for the four modes of fixation and higher for young and male patients. Harris hip score was 96 at 5 and 93 at five years and equal for the groups.

Conclusion: In this study, screws and pegs did not add any stability to the already excellent fixation of cups but lead to less satisfactory interfaces. Since osteolysis is the main clinical problem and not stability, both facts suggest more cups should be used without holes, to minimise particle penetration and osteolysis.

Introduction and Aims: Movements between the poly-ethylene insert and the metal tibial tray in modular fixed bearing total knee arthroplasty (TKA) due to poor locking mechanism is said to occur. The resulting ‘backside wear’ is proposed to be one cause to osteolysis and subsequent loosening. The purpose of this study was to determine in vivo the magnitude of movements between the poly and the tibial tray in modular metal-backed fixed bearing TKA using RSA.

Method: Four patients (six knees), mean age 70 years, operated with cemented NexGen modular fixed bearing TKA were studied 12 to 18 months after surgery. The tibial baseplates and the polyethylene liners were prepared for RSA with tantalum markers. The patients stood with the foot of the investigated leg fully weight bearing on a rotating platform. The platform (and thereby the knee) was subjected to an internal or external directed torque of 10 Nm. At the first RSA examination the patient resisted an internal directed torque, and at the second examination an external directed torque. Rotation of the polyethylene liner in relation to the base plate between these two examinations was recorded. Also the insert motion index (IMI) was determined.

Results: In three knees there was no inducible rotation of the polyethylene (rotation less than 0.03 degrees, IMI less than 93um). In the other three knees, however, rotation varied between 0.16 and 0.64 degrees, and the IMI varied between 210um and 420um.

Conclusion: This study shows that the fixed polyethylene liner in some knees can display rotatory motions in relation to the base plate. The magnitude of the motions is comparable to that found for implants extracted at revision or autopsy. Whether this is due to inferior locking mechanism, or gradual deformation of the part of the polyethylene in contact with the locking mechanism cannot be determined in this study.

Introduction Cemented fixation of the tibial component is the standard treatment for patients older than 65 with long-standing excellent results. Whether cemented fixation is best even for younger patients is still debated, and if uncemented fixation is chosen, the question remains as to whether screws are necessary as an adjunct. We present the results of a prospective randomized study comparing cemented and two modes of uncemented fixation.

Methods Thirty-five patients (mean age 56 years, range 29 to 64) were operated with the Profix (Smith& Nephew) TKA for gonarthrosis grade III to V. At the operation, the patients were randomly allocated to fixation of the tibial component with cement (Group C, n=6), uncemented fixation with hydroxyapatite (HA) coating without screws (Group HA, n=14), or uncemented fixation with HA coating and with screws (Group HA+, n=15). The implants and tibiae were prepared for RSA with tantalum markers. RSA was performed post-operatively, three, 12 and 24 months post-op.

Results There were no complications or revisions during the follow-up. For all three types of fixation the migration was larger during the initial three months, after which the migration leveled off. At three months, subsidence and tilting of the implant was significantly larger for group HA- compared to group C (P = 0.009 − 0.036), with the migration for group HA+ in between. This difference between the groups persisted up to 24 months. When examining the migration from three to 24 months, the implants in all three groups displayed very small migration, magnitudes well below the detection limit of RSA. There were no differences in magnitude of migration between the three groups between three and 24 months.

Conclusions The uncemented tibial component displays relatively large migration within the first three months compared to the cemented implant, and uncemented fixation without screws has larger migration than when screws are used. This larger initial migration for the uncemented fixation probably is due to “setting-in” of the prostheses. However, if the uncemented implant “survives” this early period, the results of the present study indicate a good long term prognosis, even when no screws are used for additional stability. This is important, since osteolysis frequently has been observed in relation to screws in the proximal tibia. One reason for the stable fixation of the uncemented implants may be the use of HA-coating.

In relation to the conduct of this study, one or more of the authors is in receipt of a research grant from a non-commercial source.

Introduction Movement between the polyethylene insert and the metal tibial tray in modular fixed bearing total knee arthroplasty (TKA) due to a poor locking mechanism is said to occur. The resulting “backside wear” is proposed as one cause of osteolysis and subsequent loosening. In vitro analysis has revealed movements between the poly and the tibial tray both in non-implanted designs as well as in implants extracted during revisions and at autopsy. Scratch marks on the surfaces at the tray-poly interface have been found indicating rotatory movements between the components. The purpose of this study was to determine in vivo the existence and magnitude of movements between the poly and the tibial tray in modular metal-backed TKA.

Methods Ten patients (median age 71) operated with the NextGen modular fixed bearing TKA due to gonarthrosis were analyzed. This TKA has lipped edges around the entire periphery of the implant to capture and secure the poly insert. The metal tray of the tibial component was equipped with five tantalum markers, and the polyethylene insert with six markers. Radiostereometric (RSA) investigation was performed within one week post-op, and at 12 months. Change in position of the poly insert in relation to the metal tray between the post-op and the 12 months investigations was analyzed as rotations about, and translations along the cardinal axis of the knee. The Insert motion index according to Engh et al (2001) was calculated.

Results Between the surgery and 12 months post-operatively there was a median external rotation of the poly in relation to the metal tray of 0.4 (range: 0.09 to 0.73). Median insert motion index was 0.36 mm (range 0.2 mm to 0.6 mm). Subsidence and lift-off of the polyethylene were very small and below the detection limit of RSA (< 0.08 mm).

Conclusions This study shows for the first time that movements do occur in vivo between the polyethylene insert and the metal tray in modular fixed bearing TKA, even in designs with a full peripheral capture mechanism. The movements occur in the plane of the metal tray (i.e. external rotation, medial-lateral and anteroposterior translation), but no movements are detected in directions out of this plane (proximal-distal translation). The magnitudes of these translations are equivalent to those found in in vitro studies of explanted components. This study thus questions the efficacy of the locking mechanism in modular fixed bearing TKA.

In relation to the conduct of this study, one or more of the authors is in receipt of a research grant from a non-commercial source.

Aims: To investigate the cup interface with different means of þxation. Methods: 83 patients (89 hips) (median age of 56 years) were operated with a uncemented hemispherical porous-coated cup made of titanium alloy (Reßection, Smith & Nephew¨) with pressþt technique. The patients were randomised to pressþt-only (PF), PF + Hydroxyapatite (PF+HA), PF + 3 screws (PF+S) and PF + 3 pegs (PF+P). The development of radiolucent lines in percentage of circumference was evaluated on x-ray þlms postoperative and at two years. Radiostereometry was used for migration and wear measurement. Results: All cups were stable after 2 years. The groups showed no signiþcant difference in migration. Radiolucencies were found in a mean of 20% of interface in PF+S, 14% in PF+P, 11% in PF and 0% in PF+HA (P = 0.005, Kruskall Wallis test). 5 focal osteolysis were found in PF+S, 1 in PF+HA and PF and none in PF+P (ns). 35 cups had a gap between the central part of the cup and acetabulum postoperatively (no differences between groups). After 2 years the gaps in the HA group had disappeared. Cup wear was highest for HA coated cups. Conclusions: Further studies are necessary to reveal whether the better implant bone interface will outweigh the risk for increased wear.