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Short Interval in Treatment of PJI

Charite University, Berlin, Germany · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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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).
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