Temperature-controlled continuous cold flow device versus traditional icing regimen following anterior cruciate ligament reconstruction: a prospective randomized comparative trial

Introduction: Anterior cruciate ligament (ACL) reconstruction requires an intensive rehabilitation program to be completely successful. Cryotherapy has been described to be helpful in reducing post-operative pain and edema. Aim of this prospective randomized study is to compare two homogeneous groups of patients, one receiving traditional icing regimen and the other a temperature-controlled continuous cold flow device, in post-operative setting after ACL reconstruction. Materials and methods: Forty-seven patients treated for ACL reconstruction using “over the top” technique were enrolled for this study. All patients received the same elastocompressive bandage. Regarding the coolant device, 23 patients were randomized to temperature-controlled continuous cold flow device (Hilotherm^® group) and 24 patients were randomized to receive ice bag (control group). The two groups were homogenous for pre-operative (age, sex, and time “lesion to surgery”) and intra-operative parameters (duration of the procedure, meniscectomy, and chondral damage). NRS (numeric rating scale), blood loss, knee volume increase at three established sites, ROM, and pain killers consumption were assessed. The subjective evaluation of the device including practicality and usefulness of the device was investigated. Results: Hilotherm group resulted in lower pain perception (NRS), blood loss, knee volume increase at the patellar apex and 10 cm proximal to the superior patellar pole, and higher range of motion (p < 0.05) in the first post-operative day. No difference in pain killers consumption was noted. Hilotherm device was considered “comfortable” and “useful” by the majority of patients. Conclusions: Hilotherm group showed significant better results in first post-operative day. Further studies with higher number of patients and longer follow-up are required to assess the beneficial effects on rehabilitation and the cost-effectiveness of the routinely use of this device. Level of evidence: II.