Lessons learnt from early failure of a patient trial with a polymer-on-polymer resurfacing hip arthroplasty.

Background and purpose - Hip resurfacing (HR) is a treatment option promoted for hip arthritis in young and active patients. However, adverse reactions to metal are a concern and the search for non-metallic bearing options proceeds. We present the first clinical study performed in patients using a newly developed hydrophilic polymer-on-polymer hip resurfacing device. Patients and methods - After performing extensive hip simulator tests, biocompatibility testing and animal tests (ISO 14242-1,3; 10993-3,4,5,10,11), approval was obtained from the IRB committee to enroll 15 patients in the first clinical study in humans using this experimental polymer-on-polymer hip resurfacing device. All surgeries were done by 2 experienced hip resurfacing surgeons. Clinical scores and standard radiographs as well as routine MRIs were obtained at regular intervals. Results - The surgical technique proved feasible with successful implantation of the new device using PMMA cement fixation on both sides without complications. Postoperative imaging revealed a well-positioned and well-fixed polymer resurfacing hip arthroplasty in all 4 initial cases. All 4 patients were free of pain and had good function for the first 2 months. However, in all 4 cases early cup loosening occurred between 8 and 11 weeks after surgery, necessitating immediate closure of the study. All 4 patients had a reoperation and were revised to a conventional THA. Retrieval analyses confirmed early cup loosening at the implant-cement interface in all 4 cases. The femoral components remained well attached to the cement. The periprosthetic tissues showed only small amounts of polymeric wear debris and there was only a very mild inflammatory reaction to this. Interpretation - Early cup loosening mandated a premature arrest of this study. After additional laboratory testing this failure mode was found to be the result of a small, yet measurable contraction in the cup size after exposing these implants to biological fluid divalent ion fluctuations in vivo. Currently used preclinical tests had failed to detect this failure mechanism. Modification of the polymer is essential to overcome these problems and before the potential of a polymer-on-polymer resurfacing arthroplasty may be further evaluated in patients.

Acute Mono-Arthritis of the Knee: A Case Report of Infection with Parvimonas Micra and Concomitant Pseudogout.

Parvimonas micra is a rare pathogen for septic arthritis and is known for its subacute onset. We report a case of acute arthritis of the knee caused by P. micra and pseudogout. Initially, calcium pyrophosphate crystals were found in the knee, which were successfully treated with a steroid injection. Only anaerobic cultures became positive. A 16S rRNA PCR-analysis was necessary to identify P. micra as causative agent, a method which is never described before in similar cases. The infection was treated with clindamycin for 6 weeks. This is the third case report of a septic arthritis caused by P. micra and the second which also reports concomitant pseudogout.

Finding the right hip implant for patient and surgeon: the Dutch strategy--empowering patients.

We describe the implementation process of hip prostheses selection in the Netherlands. The recent problems with large head metal-on-metal hip prostheses resulted in substantial damage to the surgeons' credibility and reputation in the media. This led to a true sense of urgency among orthopaedic surgeons to increase their activities to secure patient safety. The board of the Dutch Orthopaedic Association (NOV) in the Netherlands established a Dutch Hip Task Force (DHTF) with the explicit assignment of formulating criteria to classify the quality of total hip implants on the Dutch market based on survivorship. The aim was to offer unequivocal information enabling a balanced choice of total hip prosthesis. The ultimate goal of the NOV is that all implanted total hip prostheses implanted in the Netherlands are based on reliable clinical evidence. The DHTF decided to adapt the principles of the National Institute for Health and Care Excellence (NICE, UK) (www.nice.org.uk). The taskforce uses data from the registries as well as the Orthopaedic Data Evaluation Panel (ODEP). If the ODEP guidelines had been chosen as standard alone, one quarter of our listed hip components would not have been included. In our view this underlines the strength in the Dutch approach where high quality registry data and ODEP ratings are complementary and result in a list of reliable hip prostheses. Most importantly we offer patients insights into the known quality of the implants by sharing the results of our implant review. This will facilitate shared decision making by empowering patients in their knowledge on available hip arthroplasties.