The Dawn Hip - An Effective Strategy to Improve the Management of Traumatic Hip Fractures

The aim of our study was to assess, for the first time in a large study, whether there are radiological features of the acromioclavicular joint (ACJ) which vary with age or between genders and side. Clinical experience suggested that there was no clear correlation between the radiological features and symptoms arising from the ACJ. Therefore we also aimed to test the null hypothesis that there are no consistent radiological features which correspond with the need for surgical excision of the ACJ.

We analysed 240 shoulder radiographs, divided into male and female, left and right shoulders, and decades from 20 to 80 years inclusive. At the ACJ the presence of sclerosis, osteophytes, cysts and lysis were recorded, and the width of the joint measured.

These same parameters were assessed on the pre-operative radiographs for a group of 100 patients by a blinded observer. Fifty had undergone ASD (arthroscopic subacromial decompression), and 50 ASD with ACJ excision. These two groups were age matched. Statistical analyses were performed.

There was no statistical difference between any of the parameters for gender or side however with increasing age there was a significantly increased incidence of joint space narrowing and increased features of osteoarthrosis. When comparing the matched ASD and the ACJ excision groups it was found that the presence of medial sclerosis (p = 0.016) and superior clavicular osteophytes (p = 0.016) were more common in the ACJ excision group.

We concluded that there is a change in the radiological features of the ACJ with increasing age but not between sides or gender. The null hypothesis is upheld. Only 2 parameters, namely medial acromial sclerosis and superior clavicular osteophytes, are radiological features which correlate with a symptomatic acromioclavicular joint. These have poor sensitivity and specificity and therefore should not be used as a test.

Introduction: Europe has no equivalent of the US Food and Drug Administration (FDA). As a result, spinal implants can be adopted into clinical use in Europe earlier than in the US with a lesser regulatory burden. This may benefit patients, but if a device fails due to design changes that are not fully evaluated, outcomes can be compromised. The classic example in the past was the Capital Hip. If Europe had an equivalent to the FDA, oversight of implant design and design changes might prevent such occurrences.

The Prosthetic Disc Nucleus (PDN) is an implant designed to replace the nucleus of the lumbar disc in early stage symptomatic disc degeneration. The PDN originally was a paired device. Due to technical difficulties encountered by surgeons these were converted to a single implant (PDN Solo range). Mechanical testing suggested the new device would function as well as the original paired device. However, the implant was introduced into clinical practice, outside of the US, without any clinical evaluation.

Study Design: Prospective cohort study with 3 to 5 year clinical and radiological follow-up.

Objective of Study: To review the outcome of PDN Solo implanted anteriorly in the lumbar spine, define the mode of failure and describe revision strategies.

Patients and Methods: PDN Solo was used in 35 patients from September 2002 to January 2005 with a median follow-up of 49 months. Patients with discogenic back pain causing significant disability were offered nucleus replacement after an extensive process of consent. The approach was anterior retroperitoneal with the exception of L5/S1 which was transperitoneal. 17 patients were treated with PDN alone and 18 with a PDN to treat a degenerate level adjacent to an interbody fusion. Outcome measures were the Low Back Outcome Score and a Patient Satisfaction Evaluation.

Results: 14 patients have needed PDN revision. The mean time to failure was 16.5 months. There were three early extrusions, two replaced with PDNs and one converted to a fusion. Revision procedures included seven conversions to STALIF, two circumferential fusions and five posterolateral fusions.

Four more unrevised patients were identified as clinical failures. The total failure rate was therefore 51.4%. In patients with a successful outcome there was a 33 point improvement in the mean LBOS score.

In all cases of failure the PDN jacket became disrupted with concomitant fragmentation of the hydrogel core

Conclusions: Modification of the paired PDN to a single device was introduced outside the US without any clinical evaluation. In the US, the original PDN and the Solo version failed to gain regulatory approval and following the failure of the Solo it has been redesigned again. This study raises questions regarding implant design, testing and approval considering that more than 4500 PDN replacements have been carried out worldwide since 1996. Do these events call for a European equivalent to the FDA?

The aim of our study was to assess, for the first time in a large study, whether there are radiological features of the acromioclavicular joint (ACJ) which vary with age or between genders and side. Clinical experience suggested that there was no clear correlation between the radiological features and symptoms arising from the ACJ. Therefore we also aimed to test the null hypothesis that there are no consistent radiological features which correspond with the need for surgical excision of the ACJ. We analysed 240 shoulder radiographs, divided into male and female, left and right shoulders, and decades from 20 to 80 years inclusive. At the ACJ the presence of sclerosis, osteophytes and cysts were recorded, and the width and angle of the joint measured. These same parameters were assessed on the preoperative radiographs for a group of 100 patients by a blinded observer. Fifty had undergone ASD (arthroscopic subacromial decompression), and 50 ASD with ACJ excision. These two groups were age matched. Statistical analyses were performed. There was no statistical difference between any of the parameters for gender or side however with increasing age there was a significantly increased incidence of acromial sclerosis and joint space narrowing. When comparing the matched ASD and the ACJ excision groups it was found that the presence of medial sclerosis of the acromium (p = 0.016) and superior clavicular osteophytes (p = 0.016) were more common in the ACJ excision group. We concluded that there is a change in the radiological features of the ACJ with increasing age but not between sides or gender. The null hypothesis has been rejected. The presence of either medial sclerosis of the acromium, and superior clavicular osteophytes, are radiological features which correlate with a symptomatic acromioclavicular joint.