We performed a prospective, randomised, blinded clinical trial comparing metal versus polyethylene bearing surfaces in patients receiving a THA.

Forty-one patients were randomised to receive a metal (twenty-three) or a polyethylene (eighteen) insert with identical femoral and acetabular components. The metal bearing was a 28mm low carbon on high carbon couple. Patients were evaluated pre-operatively, at three, six, twelve months and annually thereafter, including an evaluation of erythrocyte and urine cobalt, chromium, and titanium, outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs.

No patients were lost to follow-up. At an average 7.2 (range 6.1 – 7.8) years follow-up there were no differences in any outcome measures or radiographic findings. Patients receiving metal liners had significantly elevated metal ion measurements. At most recent follow-up, compared to the polyethylene control group, patients receiving a metal on metal bearing had erythrocyte cobalt levels were eleven times elevated (median 1.4 μg/L (metal) vs 0.12 μg/L (poly), p< .001). Urine cobalt levels were thirty-nine times elevated (median 11.4 μg/L/day (metal) vs 0.29 μg/day (poly), p< .001) and urine chromium levels were twenty-eight times elevated (median 4.75 μg/day (metal) vs 0.17 μg/day (poly), p< .001). Additionally the metal ion levels reached an early steady state level and did not decrease over time. (Erythrocyte Co (μg/L): 1.29 (6 mos), 1.20 (1 yr), 1.0 (2 yr), 1.10 (3 yr), 1.35 (4 yr), 1.40 (5 yr)).

Both cobalt and chromium ion measurements were significantly elevated in the blood and urine of the patients randomised to receive the metal on metal THA at all time intervals. Contrary to previous reports, in 34% of patients with a metal liner, metal ion (erythrocyte cobalt) elevation was still increasing at latest follow-up, and in the overall metal on metal patient cohort, metal ion median levels were not decreasing over time. As in polyethylene wear data, metal ion results are not necessarily generalizable, but are bearing design specific.

Optimal soft tissue tension maximises function following total knee arthroplasty. Excessive tension may lead to stiffness and or pain, while inadequate tension can lead to instability. Composite component thickness is a prime determinant of this soft tissue tension. The variable component thickness provided by polyethylene inserts generally allows for 2–3mm incremental change. This study analyzed the effect of 1-mm incremental changes in polyethylene thickness on soft tissue tension. Our hypothesis was that soft tissue tension would be markedly affected by increases in insert thickness.

Computer assisted TKA was performed on eight cadaveric knee specimens (four pairs). The knees were passively moved through full flexion-extension range of motion, for each tibial construct thickness. Kinematics were recorded using the computer navigation software. Soft tissue tension was analyzed by measuring compartmental loads. A validated load cell instrumented tibial insert was used to measure medial and lateral compartmental loads independently. The effect of 1-mm increments in polyethylene thickness on compartmental loads was evaluated.

An increase in compartmental loads was measured with increasing insert thickness. Loading in contralateral compartments showed differing behaviour, reflecting varying tension in the medial and lateral sides. Many generated loads showed a reduction after reaching a maximal level with further increase in insert thickness (seven of eight specimens), indicative of tissue failure, although there were no overt indications of failure during the procedure. With a 1-mm increase in insert thickness, six of eight specimens showed an increase in peak loads greater than 100N at some point in the testing procedure, although not always with the same shim thickness.

Compartmental loads varied as a function of insert thickness. Most specimens showed signs of soft tissue “micro-failure”. The high sensitivity of compartmental loads to a 1-mm incremental increase is significant and has not been previously appreciated, especially intra-operatively. Currently available inserts with 2–3mm incremental sizes may make obtaining optimal soft tissue tension difficult. In addition to the current focus of obtaining accurate leg alignment, further computer-assisted techniques are required to address soft tissue tension.

This study reports on the clinical and wear performance of a prospective randomised controlled trial comparing highly cross-linked (XLPE) to conventional polyethylene (PE) in total hip arthroplasty at five years minimum follow-up.

One hundred patients enrolled in a prospective randomised controlled trial received identical hybrid total hip arthroplasties with the exception of the polyethylene insert. Fifty patients received a PE liner (2.5 MRads; gamma-in-nitrogen sterilization) and fifty patients received a XLPE liner (10Mrads; gas-plasma sterilization). Clinical outcomes were determined using Harris Hip, WOMAC and SF-12 scores by an independent study nurse. Femoral head penetration rates were determined using a validated radiographic technique (Hip Analysis Suite 8.0.1.1) based on radiographs at six weeks, one year and yearly post-operatively. Linear regression analysis was performed for both the entire polyethylene groups and on each patient, where the slope represents the steady state head penetration rate (after bedding in) from one to five years follow-up.

None of the patients were lost to follow-up, however, nine patients were deceased before their five year follow-up. Two patients have been revised for loose stems. At average follow-up of 6.0 years (range 5.1–6.8 years), there were no differences in Harris Hip, WOMAC or SF-12 scores. XLPE had a significantly lower (p= 0.03) steady-state head penetration rate of 0.018 mm/year compared to 0.050 mm/year for XLPE (approximately 64% reduction). Analysis of individual patient’s head penetration rates demonstrated a similar significantly lower rate with XLPE (0.004 ± 0.067 mm/year) compared to PE (0.045 ± 0.083 mm/year). Interestingly, when examined by gender, the male PE group had a significantly higher head penetration rate (0.081 ± 0.084 mm/year) than both the male and female XLPE (−0.013 ± 0.104, 0.011 ± 0.074 mm/year, respectively).

At minimum five years follow-up, there were no clinical differences between groups. After bedding-in, there was a significant lower head penetration rate with XLPE compared to PE. Thus, mid-term follow-up appears to demonstrate a significant wear reduction (based on head penetration rates) afforded by first generation XLPE. Long-term follow-up is required to demonstrate the clinical benefit of this new material.

Introduction: Optimal soft tissue tension maximises function after total knee arthroplasty (TKA). Excessive tension may lead to stiffness and or pain, while inadequate tension can lead to instability. Composite component thickness is a prime determinant of this soft tissue tension. The variable component thickness provided by polyethylene inserts generally allows for 2-3 mm incremental change. This study analyses the effect of incremental change in polyethylene thickness on soft tissue tension.

Methodology: Computer assisted (Stryker Knee Nav) TKA was performed on 8 cadaveric knee specimens (4 pairs). Kinematic data was collected through the navigation software. The soft tissue tension was analysed by measuring compartmental loads. A validated load cell instrumented tibial insert was used to measure medial and lateral compartmental loads independently. The effect of 1mm increments in polyethylene thickness on compartmental loads was evaluated.

Results: We measured an increase in compartmental loads with increasing insert thickness. However the peak loads in each compartment showed different behaviour reflecting varying tension in the medial and lateral sides. The peak loads generated also showed a reduction after reaching a maximal level with further increase in insert thickness. With a 1 mm increase in insert thickness, 50 % of specimens showed greater than 200 % increase in the peak loads in the lateral compartment.

Conclusions: The compartmental loads vary as a function of insert thickness. The high sensitivity of compartmental loads with a 1mm increment is significant and has not been previously appreciated, especially intraoperatively. The currently available TKA inserts with 2-3 mm increments may make obtaining optimal soft tissue tension difficult. In addition to the current focus of obtaining accurate leg alignment, further computer aided techniques are required to address soft tissue tension.

The pathogenesis of osteolysis in failed total hip arthroplasty is not fully understood. The purpose of this study is to identify CD4+CD25+ Regulatory T cells in periprosthetic tissues in failed total hip replacements secondary to osteolysis. Intra-operative tissue samples and peripheral blood were collected from patients undergoing revision total hip arthroplasty surgery. Regulatory T cells were present in the tissues, and significantly increased in the peripheral blood in patients with failed total hips compared to normal controls. Further characterization of these regulatory T cells are warranted as they may play a role in osteolysis in loose total hip replacements.

Osteolysis remains the most common complication following total joint arthroplasty. To date, no authors have investigated the role of CD4+CD25+ regulatory T cells (T_REG) participating in the osteolytic pathogenesis. The purpose of this study is to quantitate the presence of T_REG cells in periprosthetic tissues in failed total hip replacements secondary to osteolysis.

Fifteen consecutive patients booked for revision total hip arthroplasty secondary to osteolysis were included. Tissue samples were collected: peripheral blood (PB), synovial fluid (SF), synovial tissue (ST), and interface tissue (IT) between the failed component and the bone defect. Total lymphocytes were isolated and analyzed using fluorescent-tagged antibody cell sorting (FACS) for the presence of T_REG cells. Frozen sections of ST and IT were analyzed with immunohistochemistry for T_REG cells.

T_REG cells were significantly upregulated (p< 0.01) in the PB (68%) of revision hip patients compared to normal controls PB (44%). In the synovial tissue (ST) and interface tissue (IT), 57% of the lymphocytes isolated were TREG cells. The presence of T_REG cells in the ST and IT were confirmed with immunohistochemistry.

T_REG cells are upregulated in the peripheral blood of patients with failed total hips secondary to osteolysis. The TREG cells are also present in the synovial tissue and interface tissue.

Evidence for involvement of regulatory T cells contribute to our understanding of this complex biologic response to artificial wear particles.

Functional studies of these T_REG cells are warranted as they are upregulated in patients with loose total hip replacements.

A load cell, capable of measuring medial and lateral loads independently, was used to evaluate current methods of ligamentous balancing in total knee arthroplasty. Ten cadaveric knees were randomized with the surgeons blinded or unblinded to the load cell’s output. Before ligament resection, there were differences between medial and lateral forces (p< 0.05). Balance improved in both groups following ligamentous releases. There was a trend for superior balance (medial-lateral compressive force) with load cell feedback provided: 30°(11.1 vs. 44.4N), 60°(7.1 vs. 36.9N), and 90°(3.0 vs. 8.7N). Further in-vivo studies with this device may improve load transfer and the longevity of TKA.

The purpose of this study was to employ a tibial load cell to assess current methods of ligamentous balance during total knee arthroplasty, and to determine whether the load cell can improve load distribution between the medial and lateral compartments.

Current methods achieve imperfect load balance, however this may be improved with the assistance of an intra-operative load cell.

Intra-operative assessment and quantification of load balance with a load cell may improve the longevity of TKA.

TKA was performed on five pairs of cadaveric knees which were randomly assigned into one of two groups based upon whether the surgeons were blinded or unblinded to the load cell’s output. A validated tibial load cell, capable of measuring medial and lateral loads independently, was inserted. Compartment forces were recorded at discrete flexion angles prior to ligamentous balancing and again after soft tissue balancing with final components cemented into position.

Initially, there were significant differences between the loads in the medial and lateral compartments (p< 0.05). With soft tissue release, there was improved balance. There was a trend for superior balance (medial minus lateral compressive force) in the unblinded group at 30°: 11.1N unblinded vs. 44.4N blinded, 60°: 7.1 vs. 36.9N, and 90°: 3.0 vs. 8.7N.

Failure to achieve ligamentous balance results in instability and unequal load distribution. Current balancing techniques are not perfect, but appear to be improved with the use of the load cell. Further in-vitro and in-vivo studies are needed to improve the load distribution following TKA.

Purpose: Methylrosaniline, more commonly known as Gentian violet, is an inexpensive dye that has been used in medicine for 100 years. It has been shown, in the international literature, to have antimicrobial effects against Staphylococcus aureus, Staphylococcus epider-midis, and Pseudomonas aeruginosa. Methylrosaniline has the potential to exert an antibiotic effect while theoretically having a reduced selection pressure for resistant bacteria.

Methods: Standardized specimens consisting of Simplex P cement combined with Gentian violet, powdered tobramycin, powdered erythromycin/colistin, and no antibiotic were fashioned. These four groups were then tested against the species S. aureus, S epidermidis, and P aeruginosa using a Kirby- Bauer Agar disk diffusion test.

Results: Gentian violet showed antimicrobial activity against S aureus, S epidermidis, but not P aeruginosa. Tobramycin demonstrated activity against against all three and the preparation of erythromycin/colistin was only effective against S aureus.

Conclusions: Gentian violet demonstrates antimicrobial activity against the two most common infections in primary total joint arthroplasty.

Computer assisted navigation (CAN) has been shown to significantly improve the overall alignment obtained after total knee arthroplasty (TKA). Human error and the use of conventional jigs may be the reasons for the inaccuracy of conventional TKA. The impact of computer assisted equipment in surgeon training has not yet been established.

Three orthopaedic trainees participated in this prospective study to assess the impact of CAN upon intraoperative alignment. Each trainee’s first five (early group) and last five (late group) TKA’s were included in the study during their three month training period. A total of 30 patients were included in the study. The accuracy of conventional jig positioning was assessed simultaneously using navigation equipment. After this assessment, the actual bony resection was performed using CAN equipment.

There was a consistent trend towards improved accuracy between the early and late groups in the majority of parameters assessed. In the early group, the coronal plane tibial alignment was found to be outside the acceptable three degree range in 11 out of 15. In the late group this improved to two out of 15 (p< 0.05). An average of 2.8 degrees of tibial jig deviation during pinning was noted in the early group which improved to one degree in late group. The accuracy of jig placement in both groups was improved by CAN.

Computer assisted navigation is helpful in improving the accuracy of trainee surgeons and should prove a useful adjunct in training. Surgical accuracy using conventional jig based systems can be improved with training. Deviation of conventional tibial alignment jig during pinning is a significant factor. This aspect has not been appreciated fully in the past and can be minimised by the use of the navigation equipment. As shown in previous studies, the overall alignment using CAN is superior to what would have been obtained using conventional jigs for TKA.

Introduction and Aims: Computer-assisted bone and soft tissue balancing in total knee arthroplasty (TKA) may aid in achieving perfect knee alignment leading to better function and prosthesis survival. The ‘Measured Resection’ technique was compared to a ‘Computer Assisted Gap Equalisation’ (CAGE) technique of knee balancing in TKA.

Method: TKAs were performed on eight pairs of cadaver knees. One side of each pair was randomly selected to the control group in which measured resection was used for balancing. The experimental technique (CAGE) using a computer-assisted ligament-tensioning device to equalise gap symmetry and load was used on the contralateral side. Post-operatively, a simulator applied forces to the quadriceps and hamstring tendons and a tibial load transducer measured compartmental force at five flexion angles (0, 30, 45, 60, 90 degrees). Outcome assessment consisted of measuring gap loads and symmetry under ligament tension pre-component insertion and compartmental force post-component insertion.

Results: Although there was no significant difference between the two groups in the symmetry of the extension (p = 0.27) and flexion (p=0.07) gaps pre-component insertion, there was a trend towards improved gap symmetry in the CAGE group. As well, pre-component insertion there was a significant (p< 0.05) equalisation of flexion and extension gap loads in the CAGE group. However, post-component insertion there was no significant difference (p> 0.05 using 2-way repeated measures ANOVA) in medial to lateral compartment load balance between the two groups. As well, the measured loads with the knee in full extension (zero degrees of flexion) were significantly higher (p< 0.001) in both groups compared to other flexion angles.

Conclusion: CAGE improves knee balance pre-component insertion by improving surgical accuracy with computer-assistance. However, component design, posterior capsular tension and tibial rotation preclude sustaining the improved balance post-component insertion leaving final knee balance unchanged. Further work is needed to translate the improved surgical accuracy into improved balance following component insertion.

Introduction and Aims: Polyethylene wear continues to be the most significant issue following total hip arthroplasty (THA), leading to the current increase in use of alternative bearing surfaces. We performed a prospective, randomised, blinded clinical trial comparing metal versus polyethylene bearing surfaces in patients receiving THA.

Method: Forty-one patients were randomised to receive a metal (23) or a polyethylene (18) insert with identical femoral and acetabular components. Patients were evaluated pre-operatively at three, six, 12 months and annually thereafter, including an evaluation of erythrocyte and 24-hour urine cobalt, chromium and titanium metal ion levels, validated outcome measures (WOMAC, SF-12, Harris Hip Score) and radiographs.

Results: No patients were lost to follow-up. One patient died of unrelated causes. At an average 4.4 (range 3.3–5.1) years follow-up there were no differences in any outcome measures or radiographic findings. Patients receiving metal liners had significantly elevated metal ion measurements. At the latest follow-up erythrocyte cobalt levels were seven times elevated (median 1.2μg/l (metal) Vs 0.18μg/l (poly), p< .001). Urine cobalt levels were 41 times elevated (median 11.9μg/day (metal) Vs 0.29μg/day (poly), p< .001) and urine chromium levels were 14 times elevated (median 4.9μg/day (metal) Vs 0.36μg/day (poly), p< .001). Erthrocyte chromium, titanium and urine titanium were not significantly different between groups. As well, contrary to previous reports, there was not a significant trend towards decreasing ion levels over time.

Conclusion: In this prospective randomised blinded clinical trail comparing metal to polyethyle bearing surfaces, both cobalt and chromium ion levels were significantly elevated in the blood and urine of the patients randomised to receive the metal on metal THA.

Introduction and Aims: While highly cross-linked polyethylene has achieved widespread clinical use based on laboratory testing showing significant wear reduction, there is little clinical information demonstrating its benefits in vivo. This study reports the early clinical and wear performance of a prospective randomised controlled trial comparing highly cross-linked to standard polyethylene.

Method: One hundred patients were enrolled in a prospective randomised controlled trial in which all patients received a hybrid THR (cemented Versys stem, Triology cementless acetabulum). The two groups were virtually identical in terms of age, weight, male/female ratio and received identical hip implants, except that one half (50 patients) randomly received a highly cross-linked polyethylene liner. Clinical outcomes were determined using Harris hip, WOMAC and SF-12 scores. Two-dimensional (2D) and three-dimensional (3D) wear rates were determined using a validated radiographic technique based on AP and lateral radiographs at six weeks and one, two and three years post-operatively.

Results: At two years minimum follow-up (range two to four years), there were no differences in Harris hip, WOMAC or SF-12 scores. No patients were lost to follow-up, although five patients had died of unrelated causes. There were no infections, dislocations or revisions to date. Wear analysis at one-year post-op showed high penetration rates for both groups (mean 3D wear approximately 0.25 mm/year) consistent with the bedding-in phenomena. At most recent radiographic follow-up (two or three years), there was a statistically significant although modest difference in wear rates between the two groups with a 2D and 3D wear rate of 0.14±0.10 mm/yr and 0.15±0.02 mm/yr respectively for conventional polyethylene compared to 0.09±0.04 mm/yr and 0.11±0.02 mm/yr for cross-linked polyethylene. This represented a 32 and 29 percent reduction in 2D and 3D wear rates respectively with cross-linked polyethylene.

Conclusion: At early follow-up, there were no clinical differences. There was a modest wear reduction (approximately 30%) with highly cross-linked polyethylene, considerably less than expected based on laboratory testing. Longer follow-up, after the bedding-in process is completed, is required to demonstrate the wear reduction afforded by highly cross-linked polyethylene.

A retrospective review of 148 consecutive porous-coated hip arthroplasties (PCA) showed an incidence of thigh pain of 13% one year after surgery, and 22% at two years. Positive correlations were made with femoral stem subsidence (greater than 2 mm) and with distal periosteal and endosteal bone formation. No positive correlations were made with parameters of bone quality or component fit. Resolution of pain occurred in one-third and an anti-inflammatory agent produced partial relief in two-thirds of the patients. We conclude that thigh pain is secondary to stem instability with distal stress transfer in the absence of stable proximal fixation.