[Background]

Factors determining improvement of the long-term outcome of total knee arthroplasty include accurate reproduction of lower limb alignment. To acquire appropriate lower limb alignment, tibial component rotation is an important element for outcomes. We usually determine the tibial component rotation using the anatomical rotaional landmark of the proximal tibia and range of motion technique. In addition we followed by confirmation of overall lower limb alignment referring to the distal tibial index. When the tibia have a rotational mismatch between its proximal and distal AP axis, a larger error of the distal tibial index than those of other rotational landmark is of concern. The purpose of this study is to evaluate the reliability of the distal tibial AP axis as a reference axis of tibial compornent rotation in the intraoperative setting.

Introduction

In most cases of revision acetabular total hip arthoplasty (THA), some degree of bone loss will be accompanied. If the bone loss is massive, the management of bone defect is more challenging problem. We consider that using cementless accetabular cup for revision acetabular reconstruction is good indication when stable interface fit between the acetabular cup and bone is achieved. The purpose of this study is to review the result of revision hip arthroplasty using cementless acetabular cup with and without bone graft.

[Background]

Bipolar hemiarthroplasty (following BHA) have historically had poor results in patients with idiopathic osteonecrosis of femoral head (OFNH). However, most recent report have shown excellent results with new generation BHA designs that incorporate advances in bearing technology. These optimal outcomes with bipolar hemiarthroplasty will be more attractive procedure for young patients who need bone stock for future total arthroplasty. The purpose of the current study was to evaluate the clinical and radiographic finding of this procedure for the treatment of OFNH at our institution after 7-to 21years follow-up.

Introduction

Bi-Metric® cementless primary stem is tapered, rounded conical shaped and coated with plasma spray porous to one-third from the proximal. Fixation is achieved by a press-fit insertion in the Metaphyseal-diaphyseal junction. From 1986 until now, nearly 700 Bi-Metric® stems have been implanted at our hospital. The purpose of this study was to present the clinical and radiological findings including a survival analysis of a consecutive Bi-Metric® stems series followed for over 10 years.

Ceramic-on-ceramic alumina bearings (ALX) have demonstrated low wear with minimal biological consequences for almost four decades. An alumina-zirconia composite (BIOLOX-DELTATM) was introduced in 2000 as an alternative ceramic. This contains well-distributed zirconia grains that can undergo some surface phase transformations from tetragonal to monoclinic. We analyzed 5 cases revised at 1–7 years to compare to our simulator wear studies. For the retrieved DELTA bearings, two important questions were

how much tetragonal to monoclinic transformation was there in the zirconia phase and

The retrieval cases were photographed and logged with respect to clinical and revision details. The DELTA balls varied from 22mm to 36mm diameters. These had been mated with liner inserts varying by UHMWPE, BIOLOX-FORTE and BIOLOX-DELTA materials. Bearing features were analyzed for roughness by white-light interferometry, for wear by SEM, for dimensions by CMM and for transfer layers by EDS technique. Surface transformations on DELTA retrievals were mapped by XRD. The four combinations of 36mm diameter BIOLOX-FORTE and BIOLOX-DELTA were studied in a hip simulator, which was run in ‘severe’ micro-separation test mode to 5 million cycles. Wear rates, wear stripes, bearing roughness and wear debris were compared to the retrieval data.

In two DELTA ball cases, there were conspicuous impingement signs, stripe wear and black metallic smears. It is to be noted that the metal transfer sites (EDS) appeared to be from the revision procedures. The retrieved balls run with alumina liners showed monoclinic phase peaking at 32% on the particular surface and internal bore. On the fracture surface of case 1, the monoclinic content had increased to 40%. Various surface roughness indices were assessed on the bearings. The polished articular surfaces averaged roughness (Sa) of the order 3 nm, representing extremely smooth surfaces. The main wear zone was only marginally rougher (5 nm). In contrast the stripe wear zones had roughness of the order 55–140 nm.

In the laboratory, the DELTA bearings provided a 3–6 fold wear reduction compared to FORTE controls. Roughness of stripes increased to maximum 113nm on controls. Roughness of wear stripes showed FORTE with the highest and DELTA with the lowest values. DELTA bearings also revealed much milder wear by SEM imaging. Phase transformations showed peaks at < 30% for both main wear zone and stripe wear sites. It is hypothesized that the concentration of monoclinic phase reached a certain level due to compression contraint imposed by the alumina matrix. With implant wear, additional tetragonal grains of zirconia are exposed and these will also transform to tetragonal. This consistency between laboratory and retrieval studies confirmed the stable nature of the bearings. The BIOLOX-DELTA combination provides optimal potential for a clinically relevant reduction in stripe wear.

While there are many variation laboratory and clinical studies using metal-on-metal (MOM) bearings after introduction of the 28mm MOM THR in 1988, the mapping of wear phenomena in such retrieval cases has been mimimal. In laboratory study, 28mm MOM bearing’s wear-rate was low with “run-in” and “steady-state” than large diameter MOM without theory of fluid-filum lubrication. In clinical results were not superior to the same way of laboratory study. We present a detailed analysis of 33 retrieved MOM hip bearings with 1–11 years follow-up,

We compiled 33 retrieval cases (MetasulTM: Zimmer/CenterPulse Inc., Austin, TX) including clinical information, ion concentrations from ball diameters, cup designs and stripe wear damage. The bearing surfaces were mapped using reflected light microscope (RLM), white light interferometer (Zygo Newview 600, Zygo.) and SEM(XL-30 FEG). Wear maps were constructed according to types of surface wear identified.

Patients ranged from 36 to 76 years of age (Means: 56.9 years); 54% were males. Main causes for revision were progressive radiographic lines around the cups, osteolysis and pain. The 28mm ball diameter was used in 86% of cases (largest = 52mm ball). The CoCr liner incorporated a polyethylene adaptor in 75% of cases. Cup diameter > 50mm was present in 75% of cases. Eight femoral stems were recovered and all showed major impingement marks around the neck and five also had a metallosis (Mode-4A). Stripe wear was evident on 71% of CoCr balls with medial stripes twice as common as lateral. Stripe wear was identified in 25% of CoCr liners and extended 25–160° circumference around the liners. Clear liner rim damage was present in 10 (30%) and 3 demostrated severe damage of polyethelene adaptors.

There are many limitations to such retrieval studies. These data are biased to cases that failed due to hip pain, radiographic signs of progressive osteolysis and some with high levels of metal ions. There was also the bias of having predominantly a CoCr sandwich design (polyethylene adaptor in 75% of cases). In early 1980s, the thin walled UHMWPE cup was introduced and used larger diameter balls for decreased risk of dislocation. However, unfortunally these big-ball cups produced significant PE wear debris, and diameter trends were returned to the Chanley’s small-ball paradigm again. In the same time (late of 1980’s), these second-generation MOM (28,32mm) was introduced for low wear characteristics alternate THR bearings, with sacrificing of joint stability and motion range. However, use of the small ball added well-known risks of impingement, subluxation and dislocation with rigid cups. In this study, using the ‘damage modes’ from McKellop, normal mode-1 wear occurred in only 14% of cases whereas modes 2–4 had an incidence approaching 30% each and signs of cup impingement were evident in 64% of cases. Thus summarizing MOM wear phenomena in “small” 28mm sandwich cup designs, there was retrieval evidence showing that damage modes 2–4 likely placed these patients at risk for adverse wear effects.

Wear in polyethylene liners appears to be exacerbated by 3rd-body abrasion effects with the CoCr ball combinations used for total hip replacements. This has implications for various wear modes encountered in patients. Yet clinical and laboratory studies have offered weak and sometimes contradictory wear relationships with respect to crosslinking, ball diameter and roughness, and 3rd-body wear effects. Our hip simulator model investigated the effect of severe wear challenges by 3rd-body cement particles, using large diameter CoCr and alumina balls, with highly-crosslinked polyethylene liners (HXPE) irradiated to 75kGy compared to contemporary controls (CXPE 35kGy).

The polyethylene liners were gamma-irradiated to 35/75kGy under N2 (CXPE/HXPE). We used 32 and 44mm CoCr balls (ENCORE, Austin, TX) and 44mm alumina-ceramic (Biolox-forte, CeramTecAG) as ‘scratch-resistant’ standard of comparison. We compared 5 bearings pairs with different roughness characteristics using both new and pre-worn polyethylene liners. A 12-station orbital hip simulator with a physiological load profile (0.2kN–3kN load, frequency 1Hz) with cups mounted in “Inverted- position”. Diluted bovine serum (Hyclone Inc., Logan, UT) was used as lubricant (20mg/ml protein, 400ml volume). In phase I, all cups were run in standard (‘clean’) lubricant for 1.5 million cycles (1.5Mc). In phase II, the liners were run in a PMMA slurry of serum (5mg/ml) for 2Mc. In phase III, implants were run ‘clean’ for 1.5Mc. Wear-rate was measured each 0.25Mc event, and surface roughness measured by SEM (XL-30FEG) and white light interferometry (Newview600, Zygo) every 0.5Mc.

In phase I, Wear withnew CXPE and HXPE liners averaged 182mm3/Mc and 30mm3/Mc. Thus the HXPE liners averaged a 6.0-fold wear reduction compared to controls. Compared to new liners, the pre-worn CXPE and HXPE liners showed 10% and 25%, greater wear respectively. Here it was noted that CoCr balls maintained similar roughness (Sa:8–12nm). And alumina balls showed small, gradual increase (Sa: 2 to 2.5nm). The HXPE maintained a superior finish to CXPE controls. Roughness revealed a gradual decrease with time, pre-worn CXPE from 0.28 to 0.15um and pre-worn HXPE from 0.18 to 0.04um (Sa). In contrast, new HXPE showed a dramatic smoothing (0.8 to 0.1um) 92.8% decreased in first 0.5Mc. These effects have not been previously quantified. In phase II with abrasive mode, the liner wear-rates increased dramatically by 6 and 80-fold for CXPE and HXPE, respectively. These data confirmed that HXPE was sensitive to ‘severe’ wear against CoCr and alumina balls. In phase III, the polyethylene roughness dropped by > 90% and wear decreased to phase-I values. The wear-ratio was now 2:1 for CXPE:HXPE as predicted by the ‘diameter’ and ‘crosslinking’ algorithms.

It was clear that surface roughness was not a confounding factorfor either the CoCr or alumina balls. It was the polyethylene surface roughness that appeared to influence wear rates. Our analysis showed that there was a transient due to patches of abrasive cement transferring onto CoCr ball surfaces. Overall the actual roughness of the CoCr balls did not change and was therefore not a factor in increased polyethylene wear.

FDA approval of metal-on-metal (MOM: 28, 32mm) bearings has provided 10 years of clinical experiences in USA. However there has been no detailed mapping of wear phenomena in retrieval cases. We present an analysis of 28 cases, MOM retrievals with 1 to 10 years follow-up, radiographic reviews and metal ion studies. Ball diameters ranged from 28mm to 42mm. Two balls were the early design with skirts. Main indicators for revision were the progressive radiographic changes indicative of osteolysis, with associated hip pain. Approximately 54% of patients were males and ages ranged from 36 to 76 years of age. Only 7 femoral stems were recovered but all had impingement marks. Only three cases lacked any evidence of stripe wear and these were in very elderly patients. Approximately 85% of these cases showed some evidence of stripe wear and multiple stripes were clearly visible on 50% of the femoral balls. The medial ball stripes were twice as common as lateral. Stripe wear was identified in 25% of CoCr liners.

In the hip simulator studies generally show ‘run-in’ wear rates of 1–7mm3 per million cycles (Mc). We noted that above the 5mm3/Mc threshold, the serum generally appeared black. In contrast, the ‘steady-state’ wear rates of 0.1–1.6 mm3/Mc showed the true potential of MOM bearings. However there were often examples of higher wear (7–20 mm3/Mc), which gave confounding trends in published studies. Our studies of metal ions in the simulator lubricant provided a very accurate representation of MOM wear.

There are many limitations in comparing in-vitro to in-vivo wear performance. Our retrieval data are biased to cases that failed due to hip pain, had radiographic signs of progressive osteolysis and some showed high levels of metal ions. There was also the bias of having predominantly a CoCr sandwich design (polyethylene adaptor). Use of the small ball added the well-known risks of impingement, subluxation and dislocation with rigid cups. Using the ‘damage modes’ from McKellop, we found only normal Mode-1 wear to be rare in these cases, whereas Modes# 2–4 had an incidence approaching 30% each. Signs of impingement were evident in 85% of our cases. Thus summarizing these MOM wear phenomena in retrieved 28mm sandwich cups, the evidence implicated impingement and 3rd-body wear modes (#2–4) as the clinical risk for adverse wear effects at 10 years follow-up. The in-vitro wear studies have not yet simulated such adverse clinical effects.

From 1985 metal-on-metal (MOM) designs of resurfacing (RSA) and total hip arthroplasties (THR) have been available over a large diameter range (28–60mm). In-vitro studies indicated satisfactory low wear performance for all designs and diameters tested (wear = 0.1 to 7 mm3). While reports from many centers have been encouraging, some have reported adverse effects. We reviewed clinical and metal ion studies in large diameter retrievals and compared these to 28mm MOM cases. Patients with the latter THR ranged 36–76 years of age and were followed 9–11 years. Main finding in our revisions was osteolysis and pain. The 28mm ball was represented 86% of cases; 71% balls had stripe wear. For liners, 25% had circumferential stripe wear and impingement was evident in 64% cases. Seven cemented stems were recovered with impingement marks; 26 stems were undamaged and therefore not revised. Using the concept of ‘damage modes’ from McKellop, normal wear mode #1 was evident in only 14% of 28mm retrievals whereas incidence of ‘abnormal’ modes #2-4 approached 30% each. Thus the 28mm MOM appeared susceptible to impingement risks with CoCr liners. Summarizing MOM retrievals, damage modes 2–4 were most likely implicated in revisions. The performance of such ‘small diameter’ THRs will be contrasted to our large diameter THR and RSA experience. The questions to be reviewed include, how much of the reported MOM adversity was predictable and how much risk was due to

wear of small diameter MOM,

Ceramic-on-ceramic bearings (ALX: pure alumina) have been used for human hip joints for almost 40 years. However an alumina matrix composite with zirconia (AMC) was introduced in year 2000 as a high-strength ceramic with almost double the fatigue resistance (AMC = 80.5%ALZ and 18vol% ZrO2). However we have not found any retrieval studies reported for this new ceramic bearing.

Wear maps were generated on three retrieved AMC femoral heads (28 and 36mm diameters) using x-ray diffraction, roughness and SEM imaging techniques. The wear study ran a physiologically appropriate, micro-separation test on 36mm ceramic balls and liners (AMC/ALZ). Wear rates were determined for the four combinations of balls and cups (ALX:AMC) with mapping of main-wear and stripe-wear zones, surface-roughness and analysis of debris morphology. In addition, the zirconia transformation to monoclinic phase was studied in AMC bearings

The retrieval study showed for the first time the wear phenomena occurring on three retrieved AMC femoral heads (at 1, 3, 6 years). Two had been paired with alumina liners and one with a polyethylene liner. Case-1 featured a 36mm ball in an UHMWPE socket, case-2 was an intact 28mm AMC ball and case-3 had a fractured ball from an IDE study. Laser interferometry and SEM were used to image ceramic wear and x-ray diffraction for analysis of transformation in the zirconia phase. Main-wear zones, stripe-wear zones, metal contamination and sites of implant impingement were also characterized. Surface roughness and in-vivo aging were quantified for both non-worn and worn areas. The SEM studies showed well-preserved articular surfaces, some with faint parallel scratches still evident. The latter likely represented the manufacturer’s original polishing marks. Multiple stripe-wear sites were identified with roughness 25–65nm (Sa) whereas polished main-wear zones averaged very low at 2–3nm. Metal impingements sites stained black with transfer of titanium increased roughness up to 140nm. Mildly worn areas of case-2 AMC ball averaged 10% transformation in the zirconia phase (tetragonal to monoclinic). In the stripe-wear zones, the monoclinic phase increased to 30%. The taper-bore and fracture surfaces in case-3 averaged 30% to 40% monoclinic, respectively. The stripe-wear zones and black metal contamination on these retrieved 28mm balls were correlated to multiple impingement sites on the rim of the alumina liners and titanium shells.

The laboratory model produced stripe wear on the ceramic balls and liners. The AlX/AlX controls produced the highest run-in and steady-state wear rates at 6.3 and 2mm3/Mc respectively). In contrast, the AMC/AMC combination produced the lowest wear rates at 0.5 and 0.1 mm3/Mc, respectively). With hybrid ball:cup combinations (AlX:AMC; AMC:AlX) the wear rates were similar and showed a 3-fold reduction compared to controls. In hybrid pairings, the AMC ceramic wore preferentially more than its AlX counterpart, regardless if present as a ball or cup implant. Thus the AMC ball contributed 66% to AMC/AlX total wear whereas the ALZ ball contributed only 33% of the total AlZ/AMC wear.

This study appears to be the first documentation of wear in retrieved AMC bearing surfaces. In general, the AMC surfaces worn in-vivo corresponded well to our in-vitro wear model. The stripe-wear zones in AMC femoral heads had rougher surfaces and higher monoclinic transformation than the main-wear zone. Overall the AMC ceramic appeared more resistant to stripe-wear effects created by the micro-separation and impingement phenomena.