Comparison of a Fast Track Protocol and Standard Care After Hip Arthroplasty in the Reduction of the Length of Stay and The Early Weight-Bearing Resumption: Study Protocol for a Randomized Controlled Trial [post]

Martina Rocchi, Cesare Stagni, Marco Govoni, Alessandro Mazzotta, Leonardo Vivarelli, Antonella Orlandi Magli, Mariada Perrone, Maria Grazia Benedetti, Dante Dallari
2020 unpublished
BackgroundTo date, the hip arthroplasty is one of the most commonly performed surgical procedures, with a growing worldwide demand. In recent decades, major progress made in terms of surgical technique, biomechanics and tribology knowledge have contributed to improve the medical and functional management of the patient. This study aims to assess if the application of a fast track protocol, consisting of a pre-operative educational intervention, adequate post-operative pain control and intensive
more » ... ntrol and intensive rehabilitation intervention, reduces length of stay (LOS) and allows the early functional recovery compared to normal clinical practice for patients undergoing hip arthroplasty.MethodsThe study population consists of 90 patients with primary arthrosis of the hip with an anterior indication of hip arthroplasty. The exclusion criteria are older than 70 years, a contraindication to performing spinal anaesthesia and bone mass index (BMI) greater than 32. Participants, 45 for each group, are randomly allocated to one of two arms: fast track clinical pathway or standard care protocol. During allocation, baseline parameters such as Harris Hip Score (HHS) and Western Ontario and McMaster Universities index (WOMAC) are collected. On the third postoperative day, the functional autonomy for each patient is assessed by the Iowa Level of Assistance (ILOA) scale and it is expected the discharge for patients in the fast track group (primary outcome). On the other hand, standard care patient discharge is expected after 5-7 days after surgery. During follow-up fixed at 6 weeks, 3, 6 and 12 months, HHS and WOMAC scores are collected for each patient (secondary outcomes).DiscussionAlthough total hip replacement has become a widespread standardized procedure, at the author's knowledge, only few randomized controlled trial were performed to evaluate the effectiveness of fast track pathway vs. standard care procedure in the reduction of the LOS after hip arthroplasty. It is expected that our results collected by the application of minimally invasive surgical interventions with concomitant management of perioperative pain and bleeding, and early functional rehabilitation will contribute to enrich the understanding of clinical and organizational aspects linked to fast track arthroplasty. Trial registrationClinicalTrials.gov, NCT03875976, registered on 15 March 2019 – 'Retrospectively registered', https://clinicaltrials.gov/ct2/show/NCT03875976
doi:10.21203/rs.3.rs-42818/v1 fatcat:ge5227l3r5dk7a5mslykzwaemy