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| Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Cochin Hospital |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00449228 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis of the Hip |
Procedure: -preoperative education and total hip replacement |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 280 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | May 2010 |
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| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Philippe ANRACT, PU-PH | +33(0)1 58 41 30 98 | philippe.anract@cch.ap-hop-paris.fr |
| France | |
| Hopital Cochin | |
| Paris, France, 75014 | |
| Principal Investigator: | Philippe ANRACT, PU-PH | Assistance Publique - Hôpitaux de Paris |
More Information
| Study ID Numbers: | P051040 |
| Study First Received: | March 18, 2007 |
| Last Updated: | March 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00449228 |
| Health Authority: | France: Ministry of Health |
|
Osteoarthritis, hip replacement, education, randomized controlled trial, mini-invasive surgery |
|
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Osteoarthritis, Hip |
