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

Phase 3

• Conditions: Osteoarthritis of the Hip

• Registration Number: NCT00449228
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2007-03
• Study First Submitted: 2007-03-18
• Study First Submitted QC: 2007-03-18
• Study First Posted: 2007-03-20
• Study Start: 2007-04
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• osteoarthritis of the hip
• avascular necrosis of the hip
• patient between 40 and 90 years old (included)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to reach functional independence at hospital discharge	during de study	Time to reach functional independence at hospital discharge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Cochin; 🇫🇷 Paris, France