Hip Prosthetic Joint Infection Clinical Trial
Official title:
Efficacy and Safety of Fast-track Treatment for Prosthetic Joint Infection (PJI)
Patients with hip, knee and shoulder PJI, will be treated with a two-stage exchange
Revision.
Patients will be randomized into 2 groups: the experimental Group will get a reimplantation
after a short interval (2-3 weeks) while the control Group after a long standard interval.
Primary objective of the study is "Infection outcome". The infection-free status is defined
as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and
radiological signs of infection (e.g. no septic loosening).
Secondary objective is "Functional outcome".The functional assessment will be performed
using joint-specific scores (HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE,
OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE) involving the range of motion (ROM),
patient mobility / independency in daily life, subjective evaluation of pain using a visual
analog pain scale (1-10 points) and life-quality evaluation (EQ5D5L score).
A two-stage prosthesis exchange after a long interval of ≥6 weeks is considered the "gold standard" for management of prosthetic joint infection (PJI). We will compare the efficacy and safety of a novel surgical approach with short interval of 2-3 weeks ("fast-track") compared to the standard long interval of 6-10 weeks. Included will be patients with hip, knee or shoulder PJI, in whom all prosthetic components are removed; excluded will be patients treated with prosthesis retention or one-stage exchange and PJI caused by difficult-to-treat organisms. Patients will be randomized into short versus long interval surgical procedure, using a standard antibiotic regimen of 12 weeks in both study arms. The recruitment period of this multicenter treatment/outcome trial is 24 months, follow-up period 12 months and the calculated sample size 418 patients (i.e. 209 patient for each study arm). Primary endpoint is the infection outcome, secondary endpoint is the functional outcome, defined by established scores for joint-specific scores, pain and quality of life scores. The expected outcomes in the short interval ("fast-track") arm are (i) improved infection outcome (i.e. longer infection-free period and less treatment-related adverse events); (ii) improved functional outcome, and (iii) reduced healthcare expenses. In addition, pharmacokinetic studies will be performed and a biobank of microbes and biological samples will be established. This study has high clinical relevance for an increasing public health challenge related to device-associated infections. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01757236 -
Efficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection
|
Phase 2 |