The effect of a heel-unloading orthosis in short-term treatment of calcaneus fractures on physical function, quality of life and return to work – study protocol for a randomized controlled trial

Abstract

Background Neither for operative nor non-operative therapy standardized guidelines for rehabilitation of calcaneus fractures are existing. While there is consensus for non- or partial weight bearing, the use of supporting devices such as specific foot ankle orthosis is still a matter of debate. Recently, a heel-unloading orthosis (‘Settner shoe’) was introduced for aftercare of these fractures, allowing walking by shifting the load to the middle- and forefoot. This orthosis enables early mobilization of patients suffering from both one-and two-sided fractures. The ‘Settner shoe’ can be applied in non-operative therapy and following operations. Specifically in calcaneus fractures, early regain of physical activity has been highlighted as one of the key factors for quality of life and the ability to return to work. Thus, we hypothesize that mobilization with the ‘Settner shoe’ results in higher physical activity within the first 3 months, which is the primary outcome criterion. Methods This is going to be analyzed by a randomized controlled study comparing treatment with and without this specific orthosis. The secondary outcome measures are the time point of return to work in calcaneus fracture patients aged between 18 and 60 years. Furthermore, the American Orthopaedic Foot and Ankle Society's (AOFAS) ankle-hindfoot score, a 3-dimensional gait analysis, and the EQ-5D-3L questionnaire for quality of life are assessed. Discussion It is the first trail applying a standardized rehabilitation protocol in patients suffering from calcaneus fractures aiming to improve the non-operative part of treatment by the use of an orthosis. Trial registration: NCT03572816

Do heel-unloading orthoses improve clinical outcomes in patients after surgical treatment of calcaneal fracture? A propensity-matched, multicenter analysis of the TRON database

“…To the best of our knowledge, only one other study has compared matched patient backgrounds. 12 The most important finding of our study is that the AOFAS score was significantly better in group O than in group C at 3 months after surgery. In terms of the AOFAS components, pain and walking distance scores at 3 months after surgery were predominantly higher in group O, which means that pain was significantly lower and maximum walking distance longer at 3 months after surgery in group O.…”

“…8 Heel-unloading orthoses (HUOs) including the Settner shoe, Mars shoe, M ünchen shoe, and Graffin orthosis in Japan (Figure 1) make patients with calcaneus fractures walk after surgery by shifting the load to the forefoot and midfoot and achieve early mobilization. [9][10][11][12] A prior study also reported that the heelunloading brace for calcaneal fracture improved the range of motion (ROM) of the ankle joint. 13 However, few studies have validated the efficacy and biomechanics of the Graffin orthosis after surgery.…”