We report the five-year outcome of a randomised controlled trial which used radiostereometric analysis (RSA) to assess the influence of surface oxidised zirconium (OxZr, Oxinium) on polyethylene wear in vivo.

A total of 120 patients, 85 women and 35 men with a mean age of 70 years (59 to 80) who were scheduled for primary cemented total hip arthroplasty were randomly allocated to four study groups. Patients were blinded to their group assignment and received either a conventional polyethylene (CPE) or a highly cross-linked (HXL) acetabular component of identical design. On the femoral side patients received a 28 mm head made of either cobalt-chromium (CoCr) or OxZr.

The proximal head penetration (wear) was measured with repeated RSA examinations over five years. Clinical outcome was measured using the Harris hip score.

There was no difference in polyethylene wear between the two head materials when used with either of the two types of acetabular component (p = 0.3 to 0.6). When comparing the two types of polyethylene there was a significant difference in favour of HXLPE, regardless of the head material used (p < 0.001).

In conclusion, we found no advantage of OxZr over CoCr in terms of polyethylene wear after five years of follow-up. Our findings do not support laboratory results which have shown a reduced rate of wear with OxZr. They do however add to the evidence on the better resistance to wear of HXLPE over CPE.

Cite this article: Bone Joint J 2015;97-B:1463–9.

In this prospective study we studied the effect of the inclination angle of the acetabular component on polyethylene wear and component migration in cemented acetabular sockets using radiostereometric analysis.

A total of 120 patients received either a cemented Reflection All-Poly ultra-high-molecular-weight polyethylene or a cemented Reflection All-Poly highly cross-linked polyethylene acetabular component, combined with either cobalt–chrome or Oxinium femoral heads. Femoral head penetration and migration of the acetabular component were assessed with repeated radiostereometric analysis for two years. The inclination angle was measured on a standard post-operative anteroposterior pelvic radiograph. Linear regression analysis was used to determine the relationship between the inclination angle and femoral head penetration and migration of the acetabular component.

We found no relationship between the inclination angle and penetration of the femoral head at two years’ follow-up (p = 0.9). Similarly, our data failed to reveal any statistically significant correlation between inclination angle and migration of these cemented acetabular components (p = 0.07 to p = 0.9).

Introduction: Highly cross-linked polyethylene acetabular cups and Oxinium femoral heads were developed to reduce wear debris induced osteolysis. Laboratory tests have shown less wear with these new materials. This RSA-study was performed to compare these new materials in vivo with conventional bearing materials used in total hip arthroplasty.

Methods:150 patients were randomized to 5 groups. The patients received either a cemented Charnley mono-block stainless steel femoral stem with a 22.2 mm head or a cemented Spectron EF femoral stem with a 28 mm head. The Charnley stem articulated with a cemented Charnley Ogee acetabular cup. The Spectron EF stem was used with either cemented Reflection All-Poly EtO-sterilized ultra-high molecular weight polyethylene (UHMWPE) acetabular cups or cemented Reflection highly cross-linked polyethylene (XLPE) acetabular cups, combined with either Cobalt Chrome or Oxinium 28 mm femoral heads. Patients were followed up with repeated radiostereometric analysis (RSA) for two years to assess the rate of penetration of the femoral head into the cup (MTPM).

Results: At 2 years follow-up the mean MTPM (95 % CI) for Charnley Ogee (n=25) was 0.20 mm (0.11–0.29). For the Spectron EF femoral stem used with Reflection All-Poly UHMWPE acetabular cups the mean MTPM (CI) at 2 years was 0.40 mm (0.23–0.57) when combined with Cobalt Chrome femoral head (n=23) and 0.50 mm (0.29–0.71) when combined with Oxinium femoral head (n=16). When using the Spectron EF femoral stem with Reflection XLPE combined with Cobalt Chrome (n=27) or Oxinium (n=24) femoral head the mean MTPM (CI) at 2 years was 0.19 mm (0.10–0.28) and 0.18 mm (0.07–0.29), respectively. There were no differences in penetration between the Charnley/Ogee, XLPE/CoCr and XLPE/Oxinium groups (student t-test, p=0.5–0.8). There was no statistically significant difference between the two Reflection All-Poly UHMWPE groups (p=0.09). The groups with Reflection All-Poly cups had a statistically significant higher penetration than the three groups mentioned above (p< 0.001).

Discussion: The use of Reflection XLPE cups instead of Reflection All-Poly cups reduced femoral head penetration at 2 years. We used the Charnley Ogee cup as a reference due to a long clinical record. This cup was superior to Reflection All-Poly, but not Reflection XLPE, regarding femoral head penetration. Because the femoral head of Charnley Ogee is smaller than the Oxinium/Cobalt Chrome head it might be more clinical relevant to measure volumetric wear. The groups with Oxinium heads did not have less wear than the groups with Cobalt Chrome heads after 2 years follow-up. Further follow-up is needed to evaluate the benefits, if any, of Oxinium femoral heads in the clinical setting.

Computer-assisted techniques are developed to optimise the positioning of acetabular cups in total hip replacement. However, ordinary guiding devices are still most commonly used. The aim of this study was to evaluate the accuracy when using a simple mechanical guiding device.

30 patients were operated by an experienced hip surgeon. A lateral position and a lateral approach were used. An un cemented press fit cup (Trilogy AB) was inserted using the guiding device for this type of pros-thesis, aiming 45 degrees abduction and 20 degrees ante-version. Radiological investigations were performed one week and three months postoperatively. Frontal views of the pelvis and of the operated hip were obtained. After scanning the contour of the opening of the acetabular prosthesis was identified and digitised using an edge detecting technique. The axes of the ellipsis of the acetabular opening served for calculation of the version of the cup. A lateral view clarified whether the cup was ante- or retroverted. The abduction related to the teardrop-line was measured on the scanned pelvic radiograph.

One week postoperatively mean abduction was 50 degrees (37–62), SD 5 degrees. Mean anteversion measured on the pelvic view was 9 degrees (2–23), SD 5 degrees, compared to 11 degrees (4–24), SD 5 degrees, on the frontal view of the hip joint 50 per cent of the cups showed a deviation of more than 10 degrees from the aimed anteversion.. At average the anteversion was 2 degrees lower when measured on the pelvic view compared to that measured on the AP-view of the hip. There were no significant differences between the measurements at one week and three months.

The anteversion of uncemented press fit acetabular components tends to be lower than intended when using a simple guiding device. The risk of an unacceptable abduction seems negligible. The inaccuracy in acetabular positioning may be due to inadequate positioning of the pelvis or inaccurate insertion technique.

We performed a randomised, radiostereometric study comparing two different bone cements, one of which has been sparsely clinically documented. Randomisation of 60 total hip replacements (57 patients) into two groups of 30 was undertaken. All the patients were operated on using a cemented Charnley total hip replacement, the only difference between groups being the bone cement used to secure the femoral component. The two cements used were Palamed G and Palacos R with gentamicin. The patients were followed up with repeated clinical and radiostereometric examinations for two years to assess the micromovement of the femoral component and the clinical outcome.

The mean subsidence was 0.18 mm and 0.21 mm, and the mean internal rotation was 1.7° and 2.0° at two years for the Palamed G and Palacos R with gentamicin bone cements, respectively. We found no statistically significant differences between the groups. Micromovement occurred between the femoral component and the cement, while the cement mantle was stable inside the bone. The Harris hip score improved from a mean of 38 points (14 to 54) and 36 (10 to 57) pre-operatively to a mean of 92 (77 to 100) and 91 (63 to 100) at two years in the Palamed G and Palacos R groups, respectively. No differences were found between the groups.

Both bone cements provided good initial fixation of the femoral component and good clinical results at two years.

A customised, uncemented femoral stem was introduced clinically in 1995 after several years of development and pre-clinical testing. All the patients operated in our hospital have entered a prospective clinical study. The aim of this study is to present the short-term clinical data. Furthermore, the measurement of implant migration and the periprosthetic bone remodelling at two years is also reported.

Materials and methods: The femoral stem is designed from preoperative CT-scans, machined in Ti-alloy and circumferentially coated with a 50μm hydroxyapatite (HA) layer in the proximal 50-70%. Fifty-one patients (median age 52 years) have been followed clinically for a minimum of 3 years using the Merle-d’Aubignè score. Migration of the femoral stem has been measured with radiostereometry (RSA), the precision of the measurements is better than 0.080 mm for translations and 0.30° for rotations. Periprosthetic bone remodelling is expressed as the change in bone mineral density (BMD) in seven zones (Gruen) relative to the postoperative values. RSA- and DEXA measurements have been performed postoperatively and then after 3, 6, 12 and 24 months.

Results: One stem had to be revised after 3 months due to a periprosthetic fracture. The clinical scores were as follows (preop/3 years): Pain 2.6/5.5, ROM 3.7/5.7, function 2.7/5.9, total score 9.1/17.1. Six patients complained of thigh pain during the first two years, however, this complication resolved spontaneously in five patients within the three years follow-up. The mean subsidence after two years was 0.055 mm (SE ±0.045 mm) and the mean axial rotation was 0.29° (SE ± 0.12°). The mean bone loss in zone 7 was 34%; in the other zones the bone loss was less than 14%. The mean overall bone loss was 8%.

Discussion: The short-term clinical experiences with this patient-specific, cementless femoral stem are encouraging. The stem seems to be very stable during the first two postoperative years indicating that biological fixation of the femoral stems has been achieved. The change in the BMD was less than 14% in all Gruen zones, except for the proximal medial area where the bone loss was 34%.

The aim of this paper is to present our 7 years experience with the use of a custom femoral stem with proximal HA-coating (Unique SCP). This prosthesis was developed to optimise the þxation and the strain distribution to the proximal femur and also the biomechanics of the hip in uncemented femoral stems. Methods: 226 hips have been operated. Mean age was 51.5 years (24–66). 44.7% of the hips were dysplastic. The prostheses were designed to optimise anteversion and leg length correction. All patients were followed with radiological and clinical examination. The maximum observation time is 7 years. Merle DñAubigne score was used. Results: Three patients sustained a peroperative þssure in the proximal femur (1.3%), the þssures were treated successfully with cerclage wires. One patient sustained a femoral fracture 3 months postoperatively. A dislocation of the joint occurred by severe injuries in three patients later than three months after the operation (1.3%). These joints have been stable after non-operative reduction. Thigh pain after two years was seen in only one patient. Average total score at 3 years (82 patients) was 5.68 (preop 3.12), at 5 years (28 patients) 5.65 (preop 3.12). The pain scores at the corresponding observations were 5.65 (preop 2.71) and 5.75 (preop 2.71). There have been no radiological signs of loosening or severe bone loss in observations up to 7 years postoperatively. Conclusions: The rate of peroperative þssures, postoperative dislocations and thigh pain is low in this type of prostheses compared to most type of uncemented standard stems. This is probably due to an optimised design. The mid-terms clinical results up to seven years postop are excellent.

Aims: The aim of this study was to measure implant migration and bone remodelling of the proximal femur two years after insertion of a customized or a standard femoral stem. Materials and methods: In a prospective, randomized study 26 hips (26 patients) have been examined postoperatively and after 3, 6, 12 and 24 months using radiostereometry (RSA) and DEXA. Thirteen hips received a customized femoral stem (Unique, SCP as) and 13 hips received a standard uncemented femoral stem (ABG¨, Stryker-Howmedica). An uncemented acetabular cup (Duraloc¨, DePuy) was used in all hips. The mean age of the patients was 55 (24–67) years. Results: The median displacement of the custom/ standard femoral stems was 0.04/0.01 mm along the - medial-lateral axis, 0.08/0.02 mm along the proximal-distal axis and 0.03/0.08 mm along the anterior-posterior axis, respectively. Statistically, there was no difference between the two groups. One custom stem subsided 5.2 mm at one year, but showed no further migration at two years. The mean decrease in bone mineral density (BMD) in all Gruen zones was 6% in the Custom-group and 7% in the ABG-group. The most pronounced bone loss was seen in Zone 7 and was 21% and 25% for the two groups, respectively. Discussion: We found no statistically signiþcant difference in short-term stem migration comparing a customized and a standard, uncemented femoral stem. Furthermore, the changes in bone mineral density were almost equal in femurs with either type of prosthesis.

CT-based, customised femoral stem enables optimal reconstruction of hip mechanics and leg length. However, traditional planning and execution of cup insertion may jeopardise these biomechanical parameters. The aim of this study was to examine the agreement of the preoperative planning of cup position and the final position of the cup.

Thirty total hip replacements with an uncemented acetabular cup (Duraloc, DePuy) or a cemented cup (Elite-Plus, DePuy) were included. A customised femoral stem was used in all hips. On the preoperative X-rays the planned position and orientation of the cup had been marked prior to the surgery. The pre- and postoperative X-ray images were then digitised and scaled. The planned and final positions of the cup centre in the frontal plane was then measured relative to a horizontal line defined by the tear-drops and to a vertical line through the centre of the tear-drop on the operated side. In addition the concurrence between the planned and final cup size was examined.

In the horizontal direction the cups were positioned 1.4 (7.6) mm (median, ±2SD) more medial than planned on the preoperative X-rays. In the vertical direction the corresponding figures were 1.2 (6.6) mm (median, ±2SD) and the cups were usually placed more cranially than was planned. The maximum discrepancy between the planned and final position was 10,6 mm in the horizontal direction (medial) and 7.1 mm in the vertical direction (cranial). In 63% of the hips there was agreement between the size of the cup planned preoperatively and the cup that was finally inserted. In 25% of the hips the final cup was larger and in 12% the final cup was smaller.

In most cases the acetabular cups were inserted within a few millimetres of the planned position. The combination of a standard uncemented or cemented cup with a custom femoral stem enables the surgeon to restore hip mechanics and leg length.