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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
215
-preoperative education and total hip replacement
Hopital Cochin
Paris, France
RECRUITINGTime to reach functional independence at hospital discharge
Time to reach functional independence at hospital discharge
Time frame: during de study
Perioperative criteria :
Perioperative criteria :
Time frame: during the study
estimated blood loss
estimated blood loss
Time frame: during the study
duration of operation
duration of operation
Time frame: during the study
implant position
implant position
Time frame: during the study
implant fixation
implant fixation
Time frame: during th study
perioperative technical errors
perioperative technical errors
Time frame: during the study
Postoperative during hospital stay:
Postoperative during hospital stay:
Time frame: during the study
number of patients and number of units transfused before hospital discharge
number of patients and number of units transfused before hospital discharge
Time frame: during the study
total estimated blood loss
total estimated blood loss
Time frame: during the study
postoperative pain
postoperative pain
Time frame: during the study
skin problems
skin problems
Time frame: during the study
duration of hospital stay
duration of hospital stay
Time frame: during the study
Postoperative (3, 6 and 12 months):
Postoperative (3, 6 and 12 months):
Time frame: during the study
Harris hip score, SF-36, evaluation of satisfaction and expectation
Harris hip score, SF-36, evaluation of satisfaction and expectation
Time frame: during the study
Abduction strength, balance and gate
Abduction strength, balance and gate
Time frame: during the study
Scar assessment
Scar assessment
Time frame: during the study
complications
complications
Time frame: during the study
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