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| Name | Class |
|---|---|
| Cochin Hospital | AMBIG |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| -preoperative education and total hip replacement | Procedure | -preoperative education and total hip replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach functional independence at hospital discharge | Time to reach functional independence at hospital discharge | during de study |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative criteria : | Perioperative criteria : | during the study |
| estimated blood loss | estimated blood loss | during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe ANRACT, PU-PH | Contact | +33(0)1 58 41 30 98 | philippe.anract@cch.ap-hop-paris.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe ANRACT, PU-PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Cochin | Recruiting | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |