Osteoarthritis of the Hip Clinical Trial
Official title:
Evaluation of Preoperative Education and Mini-invasive Total Hip Replacement in Regard to the Attainment of Functional Independency and Reduction of Hospital Stay
We propose to evaluate a preoperative education of the patient and a new surgical technique
(the mini-invasive THR) that could reduce the time to achieve functional independence.
The primary objective of the trial is to assess the time to reach functional independence
after total hip replacement depending on the treatment groups: preoperative education versus
no preoperative education and mini-invasive procedure versus standard procedure. The study
hypothesis is that education and mini-invasive procedure will reduce the time to reach
functional independence.
This is a prospective trial with a double randomization.
We propose to evaluate a preoperative education of the patient and a new surgical technique
(the mini-invasive THR) that could reduce the time to achieve functional independence.
Preoperative education is compared to no education and the mini-invasive surgery is compared
to the standard group.
The education is based on explaining to the patient what will the postoperative
rehabilitation be like.
The mini-invasive THR is based on the minimisation of soft tissue trauma. It requires a
specific instrumentation to allow dissection and implantation of the prosthesis. Only few
studies have evaluated such a technique. However, these studies were retrospective or
non-randomised and results are contradictory. Therefore, a randomised controlled clinical
trial is necessary to evaluate the possible benefits and feasibility of this technique.
The primary outcome is the time to reach functional independence. Secondary outcomes
evaluate the duration of hospital stay, the quality of implantation of the prosthesis, the
postoperative morbidity, the functional benefits and the quality of life.
Methods: this monocentric randomised controlled clinical trial compares the preoperative
education versus no preoperative education (first randomization) and the conventional THR to
the mini-invasive THR (second randomization). One hundred and forty patients will be
included in each group.
Expected results: preoperative education and the mini-invasive THR are prone to decrease
time to functional independence, postoperative morbidity and duration of hospital stay.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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