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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis of the Hip
• Intervention / Treatment: Procedure: -preoperative education and total hip replacement

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 Type: Interventional
• Enrollment (Anticipated): 215
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Hopital Cochin
    • Contact: Philippe ANRACT, PU-PH; Phone Number: +33(0)1 58 41 30 98; Email: philippe.anract@cch.ap-hop-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Cochin Hospital
• Investigators: Principal Investigator: Philippe ANRACT, PU-PH, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: March 18, 2007
• First Submitted That Met QC Criteria: March 18, 2007
• First Posted (Estimate): March 20, 2007

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: June 4, 2012
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Keywords: Osteoarthritis,; mini-invasive surgery; hip replacement,; education,; randomized controlled trial,
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: P051040