Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement (ANRACT)
Recruitment status was Recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
- Time to reach functional independence at hospital discharge [ Time Frame: during de study ] [ Designated as safety issue: Yes ]Time to reach functional independence at hospital discharge
- Perioperative criteria : [ Time Frame: during the study ] [ Designated as safety issue: Yes ]Perioperative criteria :
- estimated blood loss [ Time Frame: during the study ] [ Designated as safety issue: Yes ]estimated blood loss
- duration of operation [ Time Frame: during the study ] [ Designated as safety issue: Yes ]duration of operation
- implant position [ Time Frame: during the study ] [ Designated as safety issue: Yes ]implant position
- implant fixation [ Time Frame: during th study ] [ Designated as safety issue: Yes ]implant fixation
- perioperative technical errors [ Time Frame: during the study ] [ Designated as safety issue: Yes ]perioperative technical errors
- Postoperative during hospital stay: [ Time Frame: during the study ] [ Designated as safety issue: Yes ]Postoperative during hospital stay:
- number of patients and number of units transfused before hospital discharge [ Time Frame: during the study ] [ Designated as safety issue: Yes ]number of patients and number of units transfused before hospital discharge
- total estimated blood loss [ Time Frame: during the study ] [ Designated as safety issue: Yes ]total estimated blood loss
- postoperative pain [ Time Frame: during the study ] [ Designated as safety issue: Yes ]postoperative pain
- skin problems [ Time Frame: during the study ] [ Designated as safety issue: Yes ]skin problems
- duration of hospital stay [ Time Frame: during the study ] [ Designated as safety issue: Yes ]duration of hospital stay
- Postoperative (3, 6 and 12 months): [ Time Frame: during the study ] [ Designated as safety issue: Yes ]Postoperative (3, 6 and 12 months):
- Harris hip score, SF-36, evaluation of satisfaction and expectation [ Time Frame: during the study ] [ Designated as safety issue: Yes ]Harris hip score, SF-36, evaluation of satisfaction and expectation
- Abduction strength, balance and gate [ Time Frame: during the study ] [ Designated as safety issue: Yes ]Abduction strength, balance and gate
- Scar assessment [ Time Frame: during the study ] [ Designated as safety issue: Yes ]Scar assessment
- complications [ Time Frame: during the study ] [ Designated as safety issue: Yes ]complications
| Estimated Enrollment: | 215 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
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Procedure: -preoperative education and total hip replacement
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00449228
| Contact: Philippe ANRACT, PU-PH | +33(0)1 58 41 30 98 | philippe.anract@cch.ap-hop-paris.fr |
| France | |
| Hopital Cochin | Recruiting |
| Paris, France, 75014 | |
| Contact: Philippe ANRACT, PU-PH +33(0)1 58 41 30 98 philippe.anract@cch.ap-hop-paris.fr | |
| Principal Investigator: | Philippe ANRACT, PU-PH | Assistance Publique - Hôpitaux de Paris |
More Information
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00449228 History of Changes |
| Other Study ID Numbers: | P051040 |
| Study First Received: | March 18, 2007 |
| Last Updated: | June 4, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Osteoarthritis, hip replacement, education, randomized controlled trial, mini-invasive surgery |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Hip Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on September 28, 2016