Background

Identification of novel therapeutics to accelerate acute fracture healing remains critical. A prostaglandin EP-2 receptor agonist (CP-533,536) has demonstrated acceleration of fracture healing in preclinical models. The objective of this study is to assess the efficacy of a single dose of CP-533,536 in subjects with a closed fracture of the tibial shaft using radiographic measurements compared to placebo treatment.

The distal femur fracture is a difficult injury that affects young men andelderly women. The tissue stripping that occurs with the traditional approach has been a factor in the development of complications like infection and nonunion. This study addresses the issue of minimally invasive approach. Does the LISS system really improve the results of such fracture?

Fifty-two patients were included in the trial from six academic trauma centres. Twenty-eight fractures had been randomised to be fixed with the LISS device, while twenty-four had the DCS implant. Type C3 fractures were excluded as they were not amenable for fixation with DCS system. All procedures were performed via minimally invasive technique. The LISS system had the targeter that helped with plate insertion and distal diaphyseal screws placement. Radiography was utilised in the case of the DCS distal screws insertion.

All fractures went onto union, except two participants in LISS group who had to be revised due to loss of reduction, in the early post-operative peroid. There were three nonunions in the same group. These required a re-operation. Further more, a LISS participant who had re-injured his distal femur (unrelated to LISS plate), was fixed with different implant. There was a single nonunion with the DCS group that needed revision surgery. There was one participant from each group who had drifted into varus. Neither required a re-operation. This translated into a 21% re-operation rate in the LISS system compared to 4% with the DCS device.

Our data supports the use of the DCS system in the fixation of distal femur fractures (except Type C3} via a minimally invasive approach. The LISS implant seems to be technique dependent. In our centre, the LISS plate had been discontinued in favour of the DCP and LCP systems.

Aim

To evaluate the outcome and complications of pubic symphysis plating in the stabilisation of traumatic anterior pelvic ring injuries.

The direction of penetration of the femoral head following total hip replacement has been shown at revision to be superomedial, superior or superolateral. However, it is important to study well functioning components to describe normal patterns of wear. The aim of this study was to characterise the 3D direction of penetration in standard and HXLPE.

A prospective double blind randomised control trial was conducted using Radiostereometric Analysis (RSA). Fifty-four subjects were randomised to receive hip replacements with either UHMWPE liners or HXLPE liners. All subjects received a cemented CPT stem and uncemented Trilogy acetabular component (Zimmer, Warsaw, IN, USA). The 3D penetration of the head into the socket was determined to a minimum of 7 years.

The direction of penetration between one and seven years was in a superior and lateral direction for both groups. In the HXLPE group there was no significant penetration in the coronal or sagittal planes (superiorly 0.009 mm/yr, 95% confidence interval, ±0.045, p1 = 0.68, laterally 0.003mm/yr, CI 0.031, p1 = 0.85). In the UHMWPE group there was significant penetration 0.059 mm/yr superiorly (CI 0.042, p1 = 0.01) and 0.049 mm/yr laterally (CI 0.044, p1 = 0.03). The anterior-posterior steady state penetration was not significant in either group (HXLPE p1 = 0.39, UHMWPE p1 = 0.37).

We have previously demonstrated that the penetration in the first year is creep-dominated and is in the proximal direction. From one year onwards the superolateral direction of penetration is probably due to wear. The steady-state wear direction is the same in both bearings types. It is likely that creep occurs in the direction of the Joint Reaction Force i.e. superomedial, whereas wear is perpendicular to the axis of rotation and therefore superolateral. This work may enable us to develop more accurate models for predicting wear in total hip arthroplasty.

Pseudotumours (soft-tissue masses relating to the hip joint) following metal-on-metal hip resurfacing arthroplasty (MoMHRA) have been associated with elevated serum and hip aspirate metal ion levels, suggesting that pseudotumours occur when there is increased wear. This study aimed to quantify the wear of implants revised for pseudotumours and a control group of implants revised for other reasons of failure.

A total of 30 contemporary MoMHRA implants in two groups were investigated: (1) 8 MoMHRA implants revised due to pseudotumour; (2) 22 MoMHRA implants revised due to other reasons of failure. The linear wear of retrieved implants was measured using a Taylor-Hobson Roundness machine. The average linear wear rate was defined as the maximum linear wear depth divided by the duration of the implant in vivo.

In comparison with the non-pseudotumour implant group, the pseudotumour implant group was associated with: (1) significantly higher median linear wear rate of the femoral component: 8.1 um/year (range 2.75-25.4 um/year) vs. 1.97 um/year (range 0.82-13.00 um/year), p=0.002; and (2) significantly higher median linear wear rate of the acetabular component: 7.36 um/year (range 1.61-24.9 um/year) vs. 1.28 um/year (range 0.18-3.33 um/year), p=0.001. Wear on the acetabular cup components in the pseudotumour group always involved the edge, indicating edge-loading of the bearing.

Significantly greater linear wear rates of the MoMHRA implants revised due to pseudotumour support the in vivo elevated metal ion concentrations in patients with pseudotumours. This study is the first to confirm that pseudotumour occurs when there is increased wear at the MoM articulation. Furthermore, edge-loading may be the dominant wear generation mechanism in patients with pseudotumour.

The management of discogenic pain continues to be controversial. The results for operative and non-operative management are variable. This study aims to look at the results of interbody fusion versus dynamic stabilisation in patients with discogenic pain.

Diagnosis was made by use of MRI and provocative discography. All patients had pre-operative Visual Analogue Scores and Oswestry Disability Index scores. Patients were then assessed in the post-operative period at 6 months, 1 year and 2 years. Case matched series with 19 patients in each group with a mean follow-up of 24 months. In comparison of both techniques there were no statistically significant differences but the dynamic stabilisation group had improved outcomes with both measures. The results did raise some further issues, as several patients in each group were either worse or had no significant improvement following surgery.

In conclusion this paper raises concerns regarding the use of surgery for patients with discogenic pain. If surgery is however considered, dynamic stabilisation is a valid alternative to interbody fusion.

Purpose

The optimal sequencing of radiotherapy (RT) with surgery in soft-tissue sarcomas (STS) remains undefined. We assessed the impact of RT sequencing on overall survival (OS), cause-specific survival (CSS), local failure, and distant failure.

Purpose: Interbody fusion cages have met with great success as an adjunct in the treatment of painful degenerative disc disease. One of the limitations is the need for the use of autogenous cancellous bone graft. In preclinical studies recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered in a variety of carriers has been shown to be an effective substitute for autogenous bone, resulting in more rapid and reliable healing than that seen in control groups. The goal of this study was to report the early results of the first human trial attempting to use rhBMP-2 in interbody fusion cages.

Methods: This study was an FDA approved IDE multicenter pilot study. From 1/97 to 4/97, 14 patients were entered into a prospective, randomized trial. All patients had single level lumbar degenerative disc disease that was refractory to prolonged nonoperative care and were candidates for anterior interbody fusion of L4-5 or L5-S1. After consent, patients were randomized to either the control group (N-3) and received autogenous bone inside tapered titanium fusion cages (NOVUS LT, Sofamor Danek Memphis, TN) or to the investigational group (N = 11) and received rhBMP-2 (1.5 mg/ml)(Genetics Institute, Cambridge MA) delivered in a collagen sponge (Helistat, Integra Life Sciences, Plainsboro, NJ) inside the fusion cages. Depending on the size, the sponge in each cage was soaked with from 1.3 to 2.6 ml of the rhBMP2 solution. Patients were followed at regular intervals with plain x-ray, CT scan with reconstruction, and a full panel of blood tests. Radiographs were reviewed by an independent blinded radiologist with fusion defined as < 5 degrees of sagittal motion, absence of radiolucent lines, and presence of continuous bone through the cages. Clinical results were assessed using an outcomes questionnaire including the SF-36 general health status and Oswestry low back specific instruments.

Results: All 14 patients were available for 1-year follow-up. No cages displaced and no further surgeries were required. Mean hospital stay was 2.0 days for the rhBMP-2 patients compared to 3.3 days for the autograft controls. Of the 11 rhBMP2 patients, 10 of 11 were judged to be fused at 3 months. At 6 months and 1-year all 11 rhBMP-2 patients were noted to have a solid arthrodesis. Of the 3 control patients, 2 had solid arthodesis and one had an apparent nonunion at 1 year. On sagittal CT scan reconstruction new bone growth was seen throughout and anterior to the cages that were filled with rhBMP-2. No patients had bone formation outside of the desired area. The control patient with the nonunion had a halo surrounding the cage on the sagittal CT reconstruction. This patient had persistence of low back pain. Compared to preop, the Oswestry scores at 3 months were decreased in the rhBMP-2 group (39 to 30) compared to controls which were increased (35 to 43) and both mean scores were similar at 6 months (28 and 27). Conclusion: The preliminary results from this clinical trial with rhBMP-2 inside interbody fusion cages were excellent and support a larger pivotal trial. The arthrodesis was found to occur more rapidly and reliably than in the controls, although the sample size was limited. In addition to faster bone healing, a major advantage was the elimination of bone graft donor site morbidity and realization of decreased hospital stay. No evidence of excessive bone formation or systemic complications occurred. Moreover, this study provides one of the first demonstrations of consistent and unequivocal osteoinduction by a recombinant growth factor in humans.