Mylène Jansen

72 Chapter 4 Adverse events Although a clear clinical benefit was observed for all 3 treatments, these treatments also come with a chance of adverse events. An overview of the adverse events after all treatments is given in Table 4. Of the knee joint distraction patients, about half of the patients had 1 or multiple pin tract infections, of which most (86%) were successfully treated with oral antibiotics. In the TKA group, 5 patients (14%) required knee manipulation under anesthesia because of postoperative stiffness while in the HTO group 2 patients (4%) experienced postoperative wound infection. Table 4 : Overview of adverse events Knee joint distraction (KJD TKA /KJD HTO ) Pin tract infection - Antibiotics oral - Antibiotics intravenous - with surgical irrigation and debridement 22 (10/12) 19 (10/9) 3 (0/3) 2 (0/2) Osteomyelitis (3 weeks after frame removal) - Antibiotics intravenous with surgical irrigation and debridement 1 (0/1) Possible infections diagnosed post-treatment - Antibiotics intravenous 2 (2/0) Postoperative foot drop (ankle-foot orthosis) 1 (1/0) Monotube failure (re-fixation) 1 (0/1) Breaking of bone pin during fixation 1 (0/1) Manipulation knee under anesthesia (17 days after frame removal) 1 (0/1) Total knee arthroplasty Manipulation knee under anesthesia 5 Myocardial infarction (6 days postoperatively, percutaneous coronary intervention and pacemaker implantation) 1 High tibial osteotomy Wound infection - Antibiotics oral - Antibiotics intravenous 2 1 1 Erysipelas - Antibiotics intravenous 1 1 Partial medial meniscectomy (affected knee, <6 months) 1 Number of patients is given. KJD HTO : KJD patients from the clinical trial comparing KJDwith high tibial osteotomy; KJD TKA : knee joint distraction (KJD) patients from the clinical trial comparing KJD with total knee arthroplasty. Discussion Data from both independent randomized controlled trials demonstrated sustained patient- reported clinical benefit up to 2 years for all KJD, TKA, and HTO subgroups. This benefit was clinically relevant for all groups, based on exceeding an increase of 15 points of the total WOMAC scale. 14 KJD and HTO also demonstrated a sustained 2-year increase in radiographic