Aims

Vitamin E-diffused, highly crosslinked polyethylene (VEPE) and porous titanium-coated (PTC) shells were introduced in total hip arthroplasty (THA) to reduce the risk of aseptic loosening. The purpose of this study was: 1) to compare the wear properties of VEPE to moderately crosslinked polyethylene; 2) to assess the stability of PTC shells; and 3) to report their clinical outcomes at seven years.

The primary purpose of the current study was to evaluate and compare the wear properties of vitamin E-doped, highly-crosslinked PE (VEPE) and one formulation of moderately cross-linked and mechanically-annealed ultra-high molecular weight PE (ModXLPE) in patients five years after primary THA. We also sought to understand whether polyethylene wear is associated with radiographic evidence of bone resorption or with deterioration in patient-reported outcome measures (PROMs).

A total of 221 patients from four international centers were recruited into a prospective RSA and clinical outcomes study. Seventy percent (76%) of patients received VEPE (vs. ModXLPE) liners, and 36% received ceramic (vs. metal) femoral heads. PROMs and radiographs were collected preoperatively and at one, two, and five years postoperatively. In addition, RSA radiographs were collected to measure PE wear.

We observed similar bedding in through the one-year interval and wear through the two-year interval between the two liner types. However, there was significantly more femoral head penetration in the ModXLPE cohort compared to the VEPE cohort at the five-year follow-up (p<0.001). The only variables independently predictive of increased wear were ModXLPE (vs VEPE) liner type (β=0.22, p=0.010) and metal (vs. ceramic) femoral head type (β=0.21, p=0.013). There was no association between increased wear and radiolucency development (p=0.866) or PROMs. No patients were found to have evidence of osteolysis.

At five-years postoperatively, patients treated with VEPE (vs. ModXLPE) and ceramic (vs. metal) femoral heads demonstrated decreased wear. At the longest follow-up (five years postoperatively), the wear rates for both liner groups were very low and have not led to any osteolysis or implant failures via aseptic loosening.

Osteolysis secondary to ultra-high molecular weight polyethylene (UHMWPE) wear is a leading cause of late-term implant failure via aseptic loosening in patients treated with total hip arthroplasty (THA). Radiation crosslinking of UHMWPE has been shown to decrease wear. However, the resulting polymer (crosslinked-PE) has a high free radical content. Two different methods that have been used to reduce the remaining free radicals are mechanical annealing and chemical stabilization using Vitamin E, a free radical scavenger.

The primary purpose of the current study was to evaluate and compare the wear properties of vitamin E-doped crosslinked-PE (VEPE) and one formulation of mechanically annealed crosslinked-PE using radiostereometric analysis (RSA) in patients five years after primary THA. We also sought to understand the association between polyethylene wear and patient-reported outcome measures (PROMs).

Three-hundred and five patients from six international centers were enrolled. Seventy-six percent were treated with highly-crosslinked (95 kGy) VEPE liners, and the rest received moderately-crosslinked (50 kGy) (ModXL), mechanically annealed liners. Data was collected prospectively at one-, two-, and five-year intervals.

At the 5-year follow-up, proximal femoral head penetration into the VEPE liners (median = 0.05mm (range, −0.03–1.20)) was significantly lower than the penetration into the ModXL liners (median = 0.15mm (range, −0.22–1.04)) (p<0.001). In the VEPE cohort the median proximal penetration did not increase from one- to five-year follow-up (p=0.209). In contrast, there was a significant increase in femoral head penetration for the ModXL group (p<0.001) during that same time. Multivariable regression showed that the only variable predictive of increased wear was ModXL liner type (B=0.12, p<0.001). There were no differences in PROMs between the liner groups, and there was no correlation between polyethylene wear and PROMs for the cohort as a whole.

The current study is the largest analysis of polyethylene wear at five-year follow-up using the RSA technique. We observed similar bedding in through the two-year interval between the two liner types, however, there was significantly more wear in the ModXL cohort at five-years. Currently, the wear rates for both liner groups are below the osteolysis threshold and have not led to any implant failures via aseptic loosening. Continued follow-up will provide a better understanding of the association between wear rate and clinical outcomes.

Introduction

The Primoris® femoral stem was designed to preserve bone and maintain normal stress to the proximal femur, thereby minimizing stress-shielding. The implant is anchored in the femoral neck and metaphysis without diaphysial involvement and differs from other neck prothesis by: a) Elliptical shape to fit the inner neck dimensions. b) On top of Ti– porous-coating electrochemically deposited hydroxy apatite (Bonemaster®) c) The surgical technique aims to enhance initial implant stability by compaction of neck and metaphyseal cancellous bone.

Introduction: In the attempt to improve fusion rates in spondylodesis surgery, focus has been applied on numerous factors, including surgical strategies, instrumentation-devices and –material, technical preparation of the fusion bed, stringency of radiological outcome criteria, patient-related factors such as age, sex, tobacco consumption, and severity of underlying pathology. In recent years the development of new techniques for exploring mechanisms in cellular and molecular biology have further directed focus toward more advanced biological techniques and considerations. To the authors’ knowledge, little or no attention has been focused on one of the basic and important factors in the attempt to achieve fusion, ie the impact of bone graft quantity placed at the fusion bed.

The aim of this study was to investigate the influence of autologous bone graft quantity in posterolateral instrumented spinal fusion (PLF) in respect to fusion rates.

Methods and results: A prospective clinical study in 76 patients, in which CD-instrumented posterolateral lumbar or lumbosacral spine fusion surgery was performed. The quantity of autologous bone graft applied at the fusion bed was recorded peroperatively. Spinal fusion rates were assessed by AP/lateral radiographs at one-year follow-up by two independent observers, according to our strict classification system. The impact of bone graft quantity, tobacco consumption, age and sex of the patients were analysed in respect to fusion-rates by logistic regression.

According to our classification “fusion” was seen in 76% of the patients, “non-union” in 12.7% and “doubtful”fusion in 11.3%. In “fusion” segments, the median amount of bone used was 24.4 (13–53) g and 14.7 (12.5–23.4) g in “non-union” segments. The “non-union” rate was 7.1% for non-smokers in contrast to 21.4% for patients who smoked during the first six post-operative months. The impact on fusion rates by graft quantity and cigarette smoking were significant, p< 0.006 respectively 0.035. Age and gender did not influence fusion rates. Thirty-three percent of patients with “non-union” had a corresponding failure of the implant.

Conclusions: The quantity of graft used at the fusion bed is critical for successful fusion. Based on the results presented here, we recommend a minimum of 24 g of autogenous bone graft at each intervention segment in auto-grafted posterolateral spinal spondylodesis surgery. In addition, this study underlines the importance of tobacco arrest, in at least the first six post-operative months. The data presented here strongly support the importance of quantifying or optimally standardising the amount of graft placed at each intervention segment.

Introduction: Lumbar spine fusion is now an evidence based treatment principle of low back pain. However, much controversy still exists on the choice of surgical technique. Since the source of pain may be located in the intervertebral disc, a disc removal seems logical. Instrumented and non-instrumented fusion as well as PLIF have failed to restore lumbar lordosis.

Aim: The aim of the present study was to study fusion rates, functional outcome, lumbar lordosis and complications in a RCT design using radiolucent cages and titanium instrumentation.

Materials and methods: 148 patients were bloc randomised to either PLF (72) or ALIF + PLF (76) from April 1996 to February 2000. Inclusion criteria were disc degeneration or spondylolisthesis groups 1 and 2; Age> 20 years and < 65 years. Life quality was assessed pre-operatively, one and two years post-operatively by Dallas Pain Questionnaires and by Back and Leg Pain rating scales from 0 to 10.

Results and discussion: A preliminary follow-up at one year post-op of 56 patients in each group showed no difference in admission or blood loss (921/1008 ml) and peroperative morbidity, although the operation time was significantly longer in the ALIF+ group (mean 219/344 minutes). Sagittal lordosis was restored and maintained in the ALIF+ group (p< 0.01), in contrast to the PLF group. There was no difference in functional outcome. Average back pain lasting 14 days scored 4.5 in each group, and leg pain 3.2 in the ALIF+ group versus 4 in the PLF group (NS). The re-operation rate was significantly higher in PLF after both one and two years with 9% refusion versus no refusion in the ALIF+ group. Global patient satisfaction was equal in both groups: 78% versus 76% at one year and at two years 75% versus 80% in PLF and ALIF+ groups.

Conclusion: ALIF+ fusion demands higher operative resources compared to PLF, however ALIF+ restores lordosis and provides the highest union rate and significantly fewer reoperations. A cost/effectiveness analysis after long-term follow-up may also favour the ALIF+ treatment due to improved lordosis and perhaps less degeneration of adjacent motion segments.