Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement (ANRACT)
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| ClinicalTrials.gov Identifier: NCT00449228 |
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Recruitment Status : Unknown
Verified March 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : March 20, 2007
Last Update Posted : June 5, 2012
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis of the Hip | Procedure: -preoperative education and total hip replacement | Phase 3 |
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 (Clinical Trial) |
| Estimated Enrollment : | 215 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (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 |
| Study Start Date : | April 2007 |
| Estimated Primary Completion Date : | July 2012 |
| Estimated Study Completion Date : | July 2012 |
- Procedure: -preoperative education and total hip replacement
-preoperative education and total hip replacement
- Time to reach functional independence at hospital discharge [ Time Frame: during de study ]Time to reach functional independence at hospital discharge
- Perioperative criteria : [ Time Frame: during the study ]Perioperative criteria :
- estimated blood loss [ Time Frame: during the study ]estimated blood loss
- duration of operation [ Time Frame: during the study ]duration of operation
- implant position [ Time Frame: during the study ]implant position
- implant fixation [ Time Frame: during th study ]implant fixation
- perioperative technical errors [ Time Frame: during the study ]perioperative technical errors
- Postoperative during hospital stay: [ Time Frame: during the study ]Postoperative during hospital stay:
- number of patients and number of units transfused before hospital discharge [ Time Frame: during the study ]number of patients and number of units transfused before hospital discharge
- total estimated blood loss [ Time Frame: during the study ]total estimated blood loss
- postoperative pain [ Time Frame: during the study ]postoperative pain
- skin problems [ Time Frame: during the study ]skin problems
- duration of hospital stay [ Time Frame: during the study ]duration of hospital stay
- Postoperative (3, 6 and 12 months): [ Time Frame: during the study ]Postoperative (3, 6 and 12 months):
- Harris hip score, SF-36, evaluation of satisfaction and expectation [ Time Frame: during the study ]Harris hip score, SF-36, evaluation of satisfaction and expectation
- Abduction strength, balance and gate [ Time Frame: during the study ]Abduction strength, balance and gate
- Scar assessment [ Time Frame: during the study ]Scar assessment
- complications [ Time Frame: during the study ]complications
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00449228 History of Changes |
| Other Study ID Numbers: |
P051040 |
| First Posted: | March 20, 2007 Key Record Dates |
| Last Update Posted: | June 5, 2012 |
| Last Verified: | March 2007 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
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Osteoarthritis, hip replacement, education, randomized controlled trial, mini-invasive surgery |
Additional relevant MeSH terms:
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Osteoarthritis Osteoarthritis, Hip Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |