Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Preoperative Education and Mini-invasive Total Hip Replacement in Regard to the Attainment of Functional Independency and Reduction of Hospital Stay

Conditions
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Osteoarthritis of the Hip

Intervention / Treatment
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* Procedure: -preoperative education and total hip replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: osteoarthritis of the hip avascular necrosis of the hip patient between 40 and 90 years old (included) Exclusion Criteria: history of previous hip operation (bone) patient >90 or < 40 inflammatory arthritis important proximal femur or acetabular deformity complete functional independence not possible BMI > 30

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: -preoperative education and total hip replacement|-preoperative education and total hip replacement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach functional independence at hospital discharge | Time to reach functional independence at hospital discharge | during de study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative criteria : | Perioperative criteria : | during the study | 
| estimated blood loss | estimated blood loss | during the study | 
| duration of operation | duration of operation | during the study | 
| implant position | implant position | during the study | 
| implant fixation | implant fixation | during th study | 
| perioperative technical errors | perioperative technical errors | during the study | 
| Postoperative during hospital stay: | Postoperative during hospital stay: | 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 | during the study | 
| total estimated blood loss | total estimated blood loss | during the study | 
| postoperative pain | postoperative pain | during the study | 
| skin problems | skin problems | during the study | 
| duration of hospital stay | duration of hospital stay | during the study | 
| Postoperative (3, 6 and 12 months): | Postoperative (3, 6 and 12 months): | during the study | 
| Harris hip score, SF-36, evaluation of satisfaction and expectation | Harris hip score, SF-36, evaluation of satisfaction and expectation | during the study | 
| Abduction strength, balance and gate | Abduction strength, balance and gate | during the study | 
| Scar assessment | Scar assessment | during the study | 
| complications | complications | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis,, hip replacement,, education,, randomized controlled trial,, mini-invasive surgery