Method and patients

The study was performed as a multicentre, proof-of-concept, observational study with prospective data collection. Inclusion of patients with a chronic periprosthetic hip joint infection (PJI) were followed by protocolled surgical treatment (cementless one-stage revision - the CORIHA protocol) at one of 8 participating departments of orthopaedic surgery between 2009 – 2014, and the patients enrolled in a 2-year follow-up program. A PJI were diagnosed based on adopted criteria from McPherson and Zimmerli. At the time of initiation of the study in 2009, the collaborating departments performed approximately one-fourth of all nationwide primary HJR and more than one-third of all revisions.

In total 56 PJI patients with a median age of 72 years and a median pre-operative ASA score of 2 met the established eligibility criteria and accepted to participate; 31 (55%) were males.

The cohort had a mean follow-up time of 4.0 years, with all patients followed for minimum 2 years.

The primary outcome were relapse described as re-revision due to infection (regardless of considered as a relapse or new infection). This was evaluated by competing risk analysis (competing risks: aseptic revisions and death).

Secondary, all-cause mortality was evaluated by survival analysis.

The study was approved by the local Committees on Biomedical Research Ethics.

Patients and Methods

Patients scheduled for total hip arthroplasty (THA) were randomised to receive either the study E1 (32 patients) or the control ArComXL polyethylene (35 patients). The median age (range) of the overall cohort was 66 years (40 to 76).