First metatarsophalangeal joint arthrodesis versus proximal phalanx hemiarthroplasty for hallux rigidus: feasibility study for a randomised controlled trial

BACKGROUND: Osteoarthritis of the first metatarsophalangeal joint (hallux rigidus) leads to pain and poor function and mobility. Arthrodesis is the gold standard treatment for end-stage disease. Total joint arthroplasties have been attempted, but early loosening has been attributed to dorsally directed shear forces on the metatarsal component. Metallic proximal phalangeal hemiarthroplasty theoretically avoids this. Whilst early results are promising, no comparative trials exist comparing this to arthrodesis. METHODS/DESIGN: The primary objectives are to determine the range of outcome scores between the two treatment arms (to inform a power calculation). Outcome measures will include the MOXFQ, AOFAS-Hallux and EuroQol EQ-5D-5 L. Secondary objectives are to determine the accrual rate, dropout rate and trial acceptability to both patients and surgeons. These data will allow the development of a larger trial with longer follow-up.This is a prospective randomised controlled single-centre study comparing proximal phalanx hemiarthroplasty (AnaToemic, Arthrex Ltd., Sheffield, UK) with arthrodesis (15 patients in each arm). Randomisation will be performed using a 1:1 allocation ratio in blocks of six.Patients meeting the eligibility criteria will be recruited from three foot and ankle consultant surgeon's clinics (East Lancashire Hospitals NHS Trust). If agreeable, informed consent will be obtained before patients are randomised.The outcome measure scores will be completed pre-operatively and repeated at 6 weeks, 3 months and 12 months. A radiological review will be performed at 6 weeks and 12 months to determine rates of loosening (hemiarthroplasty) and union (arthrodesis). Data on length of stay, return to work, complications and re-operation rates will also be collected.The analysis will compare the change in outcome scores between treatment groups at all follow-up time points. Scores will be compared using a Student t-test, adjusting for scores at baseline.This study will be conducted in accordance with the current revision of the Declaration of Helsinki (1996) and the ICH-GCP Guideline (International Conference on Harmonisation, Good Clinical Practice, E6(R1), 1996). This study has been approved by the sponsor, the Trust Research and Development office. Ethical approval has been received from the National Research Ethics Service (North East: 12/NE/0385 for protocol version 5.3 dated 3 June 2013). TRIAL REGISTRATION: Current Controlled Trials ISRCTN88273654

Osteonecrosis of the femoral head in patients with type 1 human immunodeficiency virus infection: clinical analysis and review

Osteonecrosis of the femoral head (ONFH) typically affects relatively young, active patients and frequently follows an unrelenting course resulting in considerable loss of function. In human immunodeficiency virus-infected patients, ONFH is a growing problem. Etiology, pathogenesis, and treatment of ONFH in these patients remain controversial. We analyzed retrospectively patients with ONFH in a series of 815 patients followed in our AIDS reference center. Six patients out of the 815 were affected by ONFH (0.74%). The sex ratio was 1. Two of the six patients (33.3%) had no evidence of risk factor, whereas four patients (66.6%) had risk factors. One patient had three cumulated risk factors which were corticosteroids, chemotherapy, and radiotherapy. For this patient, the onset time for ONFH was shorter (36 months). It is difficult to attribute the effect to any single class of antiretroviral agents because combination therapy is standard of care, and a change in therapies is common. All classes of antiretroviral drugs have been used: protease inhibitors (mean use duration of 15.2 months before the ONFH onset), non-nucleoside reverse transcriptase inhibitors (12 months), and nucleoside reverse transcriptase inhibitors (40.5 months). ONFH was bilateral in four cases (66.6%) and unilateral in two cases (33.3%). One patient had other osteonecrosis location (both shoulders). ONFH was classified on plain radiography stage IV in five patients and stage III in one patient. All patients received initial medical treatment. It consisted of painkillers and non-weight bearing of the hip. All were finally operated on by total hip arthroplasty (THA). The average interval between ONFH diagnosis and the first THA was 10.3 months for the six patients. A controlateral THA was performed for three patients after a mean interval of 23.3 months after ONFH diagnosis. Of the nine implanted prostheses, four were cemented, four were cementless, and one was resurfacing prosthesis