Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449228
Status:
UNKNOWN
Last Update Posted:
2012-06-05
First Post:
2007-03-18
Brief Title:
Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANRACT
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None