Mylène Jansen

Clinical evidence and molecular mechanisms of KJD 191 10 Table 1 : Overview of knee joint distraction clinical studies Study Design Number, type of patients Age (years) Treatment Follow-up Outcomes Deie et al. (2007) 14 & (2010) 20 Retrospective n=6 general- ized OA 51.7 (SD 7.8) Hinged custom- ized distraction + BMS, 2–3 mths Mean 2.5 yrs (range 14–51 mths) PROMs, radiographs, arthroscopy Abouheif et al. (2010) 19 Case report n=1 osteo -chondral defect 18 Hinged custom- ized distraction + bone graft, 3 mths 4.5 yrs Radiographs, arthroscopy, MRI Intema et al. (2011); 21 Wiegant et al. (2013); 22 Van der Woude et al. (2017); 16 Jansen et al. (2018) 23 Prospective n=20 OA indication TKA 48.5 (SEM 1.3) Dynamic Mono- tubes distraction, 2 mths 3, 6, 9 and 12 mths; 18 and 24 mths; 5 yrs; 9 yrs PROMs, radiographs, MRI, system- ic biomarkers Aly et al. (2011) 15 Controlled trial ( vs debridement) n=19 OA Range 39–65 Ilizarov distraction + debridement; 4 wks Mean 5.5 yrs (range 58–82 mths) PROMs, radiographs Van der Woude et al. (2017); 24 Jansen et al. (2019) 25 RCT ( vs HTO) n=22 OA indication HTO 51.2 (SEM 1.1) Dynamic Mono- tubes distraction, 6 wks 3, 6, 9, and 12 mths; 2 yrs PROMs, radiographs, MRI, system- ic biomarkers Van der Woude et al. (2017); 26 Jansen et al. (2019) 25 RCT ( vs TKA) n=20 OA indication TKA 54.9 (SEM 1.8) Dynamic Mono- tubes distraction, 6 wks 1 yr; 2 yrs PROMs, radiographs, MRI, system- ic biomarkers Jansen et al. (2020) 13 Retrospective n=84/41* OA 53.1 (SD 6.9) Dynamic Mono- tubes distraction, 6 wks 1 yr PROMs Studies in progress, no results published yet Jansen Prospective n=65 OA KneeReviver 1 yr PROMs; radiographs Pandit RCT n=172 OA indication (T)KA Multiple devices To be started PROMs; radiographs In case not all patients in the trial were evaluated on outcome measures (yet), the number of evaluated patients is indicated with *. BMS: bone marrow stimulation; HTO: high tibial osteotomy; OA: osteoarthritis; PROMs: patient-reported outcome measures; RCT: randomized controlled trial; SD: standard deviation; SEM: standard error of the mean; TKA: total knee arthroplasty. In 2011, the first open prospective study was published in which 20 knee OA patients were treated with Dynamic Monotubes (Stryker) resulting in immobilization of the knee joint during the 2 months distraction. 21 In the same year a controlled study was published in which 19 OA patients were treated with an Ilizarov distraction frame for 4 weeks (also immobilizing the joint during distraction) in combination with debridement. 15 Both these studies demonstrated a clear clinical as well tissue structure improvement upon treatment. In the meantime, two randomized studies (RCTs) were initiated using 6-week distraction with