Large wear rate reductions have been shown for crosslinked PE in simulators and short- to mid-term clinical wear studies. However, concerns persist about long-term in-vivo oxidation (especially with annealed PE), late accelerating wear and the possibly higher osteolytic potential of crosslinked PE particle debris. This is the first long-term study comparing conventional to crosslinked PE investigating whether the wear reduction is maintained in the long-term and if reduced osteolysis becomes evident. In a prospective study 48 primary THA patients (Stryker ABG-II, 28mm CoCr heads) were randomized to either receive a first generation crosslinked PE (Stryker Duration: 3MRad gamma irradiation in N2, annealed) or then conventional, now “historic” PE (3MRad gamma irradiation in air). Both groups were statistically non-different (p>0.1) regarding age (63.9 years), gender, BMI, stem and cup size, cup inclination, liner thickness or pre- and post-op HHS leaving the insert material as the only variable. Patients were followed-up annually using the Harris Hip score, AP and lateral radiographs and digital wear measurements using Roman V1.70 [1, 2]. Wear and radiographic signs of osteolysis were analysed at a mean follow-up of 12.9 years (12.0–13.3). Groups were compared using the t-test (means) or the Fisher Exact test (proportions).Introduction
Materials & Methods
While squeaking ceramic bearings in total hip arthroplasty are increasingly reported in the literature, the etiology remains unclear. Cup inclination and anteversion have been correlated with the phenomenon but even amongst well positioned cups bearing noise is observed. Most studies do not distinguish between different types of noise or incidence rate and do only investigate actively complaining patients. This study analysed the incidence of ceramic bearing noise in a single type of hip implant and investigates correlations with patient, implant and surgery parameters. In a consecutive series of 145 ceramic-on-ceramic primary hips (Stryker ABG-II, 28mm head) in 132 patients (m/f=72/60, avg. age=54yrs) and an average follow-up of 3.0 (1–7) years, noisy bearings were identified by a patient questionnaires stating the type of noise (squeaking, clicking, scratching, combinations), time of initial incidence, incidence rate (permanent, often, sometimes, rare) and type of movement. Patient demographics (age, gender, height, weight, BMI, side of surgery, leg length difference), implant parameters (cup and stem size, neck length) and surgery parameters (cup and stem position, leg length correction) were recorded and compared between the noisy and silent groups (t-test, Fisher Exact test). Twenty-eight noisy hips (19.3%) were identified with 14 patients reporting squeaking, 16 clicking and 5 scratching including 7 with a combination of noises. Quasi permanent noises were reported for 7 hips (2 often) but in 17 cases the noise appeared only sometimes (2 rare). The average time of first incidence was 1.74 years port-op with 7 hips reporting noise directly after operation and 15 after 2 years or more. Silent and noisy hips were statistically not different regarding age, gender, follow-up time, side of operation, height, weight, BMI, cup and stem size, leg length difference or stem position. Significant differences were identified with the noise group having a steeper cup inclination (49.9° vs 46.9°, p<
0.05) and less frequent shorter (−2.7mm) necks (0 vs 22%, p<
0.01) but more frequent longer (+4mm) necks (50% vs 37%, p<
0.05). Leg length correction was performed less frequent (31 vs 55%, p<
0.01). In the noise group 5 (17%) and in the silent group only 1 (0.9%) cup revisions was performed (p<
0.01). The incidence of noisy ceramic bearings was higher than usually reported (<
5%) as not only actively complaining subjects but all patients were interviewed. Cup position was confirmed to be a contributing factor but patient weight, height or BMI did not play a role. However, the use of long necks, the absence of short necks and less frequently performed leg length corrections significantly contributed to producing bearing noise. Biomechanical restoration, preoperative planning and soft tissue tension seem to be important factors in bearing noise etiology.
At 8-years the wear rate was significantly (p<
0.01) lower for Duration [0.088 ± 0.03 mm/yr (0.02–0.14)] than conventional PE [0.142 ± 0.07 mm/yr (0.05–0.31)]. This reduction (−38%) compared well to the simulator (−45%) and did not change over time (−33% at 5-years). Radiolucencies and signs of osteolysis were also less in the Duration group (n.s.).
The annual wear rates were compared and intra-observer variability was calculated as the difference between both measurements (precision). The average time it takes to measure one image (without format conversions) was documented and practicality of daily clinical use was evaluated.
The precision was (mean +/− SD): Martell = 1.74+/−1.53, Hyperview = 0.36 +/−0.92, Pro-X = 0.10+/−0.11 Roman = 0.08 +/−0.08. The average measuring time per image was: Martell = 94s, Hyperview = 94s, Pro-X = 92s Roman = 158s.
Proximal bone resorption occurred in 27% (R1) or 34% (R7) which is lower than the values reported for the ABG-I stem (R1: 48%, R7: 45%). Bone resorption was significantly higher with tight than non-tight mid-stem fit (69% vs 27%, p=0.04). The same trend was true for tight distal fit (56% vs 37%). Cancellous densifications were frequent at mid-stem level (R2: 83%, R6:88%) but much less distally (R3: 44%, R5:25%). No influence of fit &
fill was measured. Cortical densifications were noted in 16% (ABG-I 15%) overall with a higher proportion measured for tight distal fit (25%) than loose distal fit (6%, p=0.07). A similar observation was made for cortical thickening (11% overall, tight:non-tight=16%:6%). Pedestal formation (17% overall) was more likely with a non-tight proximal fit (23% vs 12%) and mid-stem fit (20% vs 8%) A proximal tight fit was achieved more frequently with normal (55%) and stovepipe femora (50%) than champagne flute femora which had the highest proportion of tight distal fit (85%).
As LTP occurred with non-tight fit it seems that elastic mismatch is not the main cause. Less proximal bone resorption and less distal densifications confirm the design changes from ABG-I to ABG-II.
Three cross sections were cut from the metaphyseal femur and surrounding bone proximal to Gruen zones 2 and 6 (regions with HA coating). The three sections were A (proximal), B (mid-part) and C (distal). Sections were prepared using the Donath technique and then paragon stained for quantitative histomorphometry using an Axioskop microscope (Carl Zeiss, Germany) with image analysing (SAMBA, France). For each segment the total implant perimeter, percentage of implant perimeter covered by bone and the total percentage of residual HA coating were measured. Bone implant contact was defined as direct ongrowth of bone to the coating or the titanium surface.
Bone ongrowth ranged between 18%–56% and was independent of the time in-vivo. Bone ongrowth was most strongly correlated to patient age with younger patients having significantly higher bone ongrowth (p=0.001). Bone ongrowth was correlated with HA-resorption only in the most proximal zone A (p=0.001) with lower ongrowth associated with lower levels of residual HA. However, HA resorption was not significantly correlated with patient age. HA resorption was significantly higher most proximally with less residual HA (13.0%) than mid-stem (22.6%, p=0.05) and distal (28.1%, p=0.05). Metaphyseal stem level and bone ongrowth were not significantly correlated in this manner.
Bone ongrowth but not HA resorption was strongly correlated to patient age indicating that the bone remodelling process is more affected by individual bone health than it can be stimulated by HA coating. HA resorption increased significantly from the distal to mid-stem and the most proximal coating level in the same way as stress shielding and thus osteoclastic stimulation goes up.
This study confirms that the Vancouver classification and the modified algorithm for the management of PPF are a simple,reproducible classification system also for the uncemented treatment modality. Conservative treatment is a valid option in case of a stable implant, while in case of a loose implant surgical intervention is mandatory.
For the ABG-I cup the literature review gave survival rates between 59%–97% after 8–10 years. In our own study cup survival was 97.4% at 10 years. Looking at PE-wear, the literature gave average wear rates ranging from 0.24 to 0.32mm/year, values clearly above the wear rate boundary of 0.10–0.15mm/year usually considered as critical. In our own study augmented PE-wear (>
0.15mm/year) was noted in 23.6% of all implants. The majority (77%) of these implants were from patients younger than 70 years although this group only represented 57% of the total. The revision rates at 10 years reflect a similar trend with values much higher for patients below 70 years (2.8%) than above(4.9%).
In a preliminary experiment the paired radii and femora of dogs were tested for bone mineral mass and mechanical properties including the load at break, the ultimate bending strength and the modulus of elasticity; symmetry was observed for most of the parameters determined. The influence of the elasticity of materials used for the internal splintage of bone and its relationship to bone remodeling were then investigated for stainless steel and plastic plates applied to the femora of dogs. A significant decrease in bone mineral mass per centimetre length of bone and in mechanical properties was demonstrated for the femora plated with steel, and microradiography showed that this was due to massive endosteal resorption. A model for determining the influence of protection from stress in bone is presented.