Background There has been increasing concern of metalon-metal (MOM) hip replacements regarding adverse reactions to metal debris. Information regarding prevalence and risk factors for these adverse reactions is scarce. Questions/purposes The primary purposes of our study were to determine (1) the prevalence of adverse reactions to metal debris among patients who received small-headed (\ 50 mm) Articular Surface Replacement (ASR TM ) prostheses in hip resurfacing procedures or the ASR TM XL prostheses during THAs at our institution, and (2) the risk factors for adverse reactions to metal debris and if they are different in hip resurfacing replacements compared with THAs? Methods Small-headed ASR TM prostheses were used in 482 operations (424 patients) at our institution. After the recall of ASR TM prostheses, we established a systematic screening program to find patients with adverse reactions to metal debris. At a mean of 4.9 years (range, 0.2-8.1 years) postoperatively, 379 patients (435 hips) attended a screening program, which consisted of clinical evaluation, whole blood cobalt and chromium measurements, and crosssectional imaging.Results At followup, 162 hips (34%) have been revised. The majority (85%) were revised owing to causes related to adverse reactions to metal debris. The 7-year survivorship was 51% for the ASR TM hip replacement cohort and 38% for the ASR TM XL THA cohort, respectively. Reduced cup coverage was an independent risk factor for adverse reactions to metal debris in both cohorts. High preoperative ROM, use of the Corail 1 stem, and female gender were associated with an increased risk of adverse reactions to metal debris only in patients undergoing THA. Conclusions Adverse reactions to metal debris are common with small-headed ASR TM prostheses. Risk factors for these adverse reactions differ between hip resurfacing procedures and THAs. Our results suggest a more complicated failure mechanism in THAs than in hip resurfacing procedures.

BackgroundProximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al. demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best treatment method. Several publications, including a Cochrane review outline the need for high-quality, well-designed randomized controlled trials.Methods/DesignThe study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score and the secondary outcome measures will be the EuroQol-5D (EQ-5D) value, OSS, Constant-Murley Score, VAS, and 15D.Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period.DiscussionThis publication presents a prospective, randomized, national multi-center trial. It gives details of patient flow, randomization, aftercare and also ways of analysis of the material and ways to present and publish the results.Trial registrationClinicalTrials.gov identifier: NCT01246167

Level IV, therapeutic study.

Contradicting the current international guidelines, our results suggest that it seems beneficial to combine routine metal ion measurement with clinical assessment, even in patients with well-functioning BHRs. Further follow-up will reveal whether new PTs will develop in these patients and BHR survivorship in the longer term.

We conducted a retrospective study to assess the prevalence of adverse reactions to metal debris (ARMD) in patients operated on at our institution with metal-on-metal (MoM) total hip replacements with 36 mm heads using a Pinnacle acetabular shell. A total of 326 patients (150 males, 175 hips; 176 females, 203 hips) with a mean age of 62.7 years (28 to 85) and mean follow-up of 7.5 years (0.1 to 10.8) participating in our in-depth modern MoM follow-up programme were included in the study, which involved recording whole blood cobalt and chromium ion measurements, Oxford hip scores (OHS) and plain radiographs of the hip and targeted cross-sectional imaging. Elevated blood metal ion levels (> 5 parts per billion) were seen in 32 (16.1%) of the 199 patients who underwent unilateral replacement. At 23 months after the start of our modern MoM follow-up programme, 29 new cases of ARMD had been revealed. Hence, the nine-year survival of this cohort declined from 96% (95% CI 95 to 98) with the old surveillance routine to 86% (95% CI 82 to 90) following the new protocol. Although ARMD may not be as common in 36 mm MoM THRs as in those with larger heads, these results support the Medicines and Healthcare Products Regulatory Agency guidelines on regular reviews and further investigations, and emphasise the need for specific a follow-up programme for patients with MoM THRs.