Clinical trial NCT00449228: Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis of the Hip
Keywords: Osteoarthritis,
hip replacement,
education,
randomized controlled trial,
mini-invasive surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Cochin Hospital
First posted: 2007-03-20
Enrollment: 215
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to reach functional independence at hospital discharge
timeFrame: during de study
Secondary outcomes:
measure: Perioperative criteria :
timeFrame: during the study
measure: estimated blood loss
timeFrame: during the study
measure: duration of operation
timeFrame: during the study
measure: implant position
timeFrame: during the study
measure: implant fixation
timeFrame: during th study
measure: perioperative technical errors
timeFrame: during the study
measure: Postoperative during hospital stay:
timeFrame: during the study
measure: number of patients and number of units transfused before hospital discharge
timeFrame: during the study
measure: total estimated blood loss
timeFrame: during the study
measure: postoperative pain
timeFrame: during the study
measure: skin problems
timeFrame: during the study
measure: duration of hospital stay
timeFrame: during the study
measure: Postoperative (3, 6 and 12 months):
timeFrame: during the study
measure: Harris hip score, SF-36, evaluation of satisfaction and expectation
timeFrame: during the study
measure: Abduction strength, balance and gate
timeFrame: during the study
measure: Scar assessment
timeFrame: during the study
measure: complications
timeFrame: during the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe ANRACT, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: