Primary stability of a short bone-conserving femoral stem: a two-year randomized controlled trial using radiostereometric analysis.

Aims: The aim of this study was to determine the stability of a new short femoral stem compared with a conventional femoral stem in patients undergoing cementless total hip arthroplasty (THA), in a prospective randomized controlled trial using radiostereometric analysis (RSA). Patients and Methods: A total of 53 patients were randomized to receive cementless THA with either a short femoral stem (MiniHip, 26 patients, mean age: 52 years, nine male) or a conventional length femoral stem (MetaFix, 23 patients, mean age: 53 years, 11 male). All patients received the same cementless acetabular component. Two-year follow-up was available on 38 patients. Stability was assessed through migration and dynamically inducible micromotion. Radiographs for RSA were taken postoperatively and at three, six, 12, 18, and 24 months. Results: At two years, there was significantly less subsidence (inferior migration) of the short femoral stem (head, 0.26 mm, 95% confidence interval (CI) 0.08 to 0.43, sd 0.38; tip, 0.11 mm, 95% CI -0.08 to 0.31, sd 0.42) compared with the conventional stem (head, 0.62 mm, 95% CI 0.34 to 0.90, sd 0.56, p = 0.02; tip, 0.43 mm, 95% CI 0.21 to 0.65, sd 0.44, p = 0.03). There was no significant difference in dynamically inducible micromotion, rate of complications or functional outcome. Conclusion: This study demonstrates that the short femoral stem has a stable and predictable migration. However, longer-term survival analysis still needs to be determined. Cite this article: Bone Joint J 2018;100-B:1148-56.

Surrogate markers of long-term outcome in primary total hip arthroplasty: A systematic review.

OBJECTIVES: High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA). METHODS: We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA. Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines. We conducted a search of Medline and Embase (OVID) databases. Separate search strategies were devised for the Cochrane database and Google Scholar. Each search was performed to include articles from the date of their inception to June 8, 2015. RESULTS: Our search strategy identified 1082 studies of which 115 studies were included for full article review. Following review, 17 articles were found that investigated surrogate markers of long-term outcome. These included one systematic review, one randomised control trial (RCT), one case control study and 13 case series. Validated surrogate markers included Radiostereometric Analysis (RSA) and Einzel-Bild-Röntgen-Analyse (EBRA), each measuring implant migration and wear. We identified five RSA studies (one systematic review and four case series) and four EBRA studies (one RCT and three case series). Patient Reported Outcome Measures (PROMs) at six months have been investigated but have not been validated against long-term outcomes. CONCLUSIONS: This systematic review identified two validated surrogate markers of long-term primary THA outcome: RSA and EBRA, each measuring implant migration and wear. We recommend the consideration of RSA in the pre-market testing of new implants. EBRA can be used to investigate acetabular wear but not femoral migration. Further studies are needed to validate the use of PROMs for post-market surveillance.Cite this article: T. T. Malak, J. A. J. Broomfield, A. J. R. Palmer, S. Hopewell, A. Carr, C. Brown, D. Prieto-Alhambra, S. Glyn-Jones. Surrogate markers of long-term outcome in primary total hip arthroplasty: A systematic review. Bone Joint Res 2016;5:206-214. DOI: 10.1302/2046-3758.56.2000568.

Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial.

OBJECTIVE: To evaluate the efficacy of homoeopathic immunotherapy on lung function and respiratory symptoms in asthmatic people allergic to house dust mite. DESIGN: Double blind randomised controlled trial. SETTING: 38 general practices in Hampshire and Dorset. PARTICIPANTS: 242 people with asthma and positive results to skin prick test for house dust mite; 202 completed clinic based assessments, and 186 completed diary based assessments. INTERVENTION: After a four week baseline assessment, participants were randomised to receive oral homoeopathic immunotherapy or placebo and then assessed over 16 weeks with three clinic visits and diary assessments every other week. OUTCOME MEASURE: Clinic based assessments: forced expiratory volume in one second (FEV(1)), quality of life, and mood. DIARY BASED ASSESSMENTS: morning and evening peak expiratory flow, visual analogue scale of severity of asthma, quality of life, and daily mood. RESULTS: There was no difference in most outcomes between placebo and homoeopathic immunotherapy. There was a different pattern of change over the trial for three of the diary assessments: morning peak expiratory flow (P=0.025), visual analogue scale (P=0.017), and mood (P=0.035). At week three there was significant deterioration for visual analogue scale (P=0.047) and mood (P=0.013) in the homoeopathic immunotherapy group compared with the placebo group. Any improvement in participants' asthma was independent of belief in complementary medicine. CONCLUSION: Homoeopathic immunotherapy is not effective in the treatment of patients with asthma. The different patterns of change between homoeopathic immunotherapy and placebo over the course of the study are unexplained.