Osteoarthritis of the Hip
Conditions
Keywords
Osteoarthritis,, hip replacement,, education,, randomized controlled trial,, mini-invasive surgery
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.
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.
Interventions
PROCEDURE-preoperative education and total hip replacement
-preoperative education and total hip replacement
Sponsors
Cochin Hospital
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach functional independence at hospital discharge | during de study | Time to reach functional independence at hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| estimated blood loss | during the study | estimated blood loss |
| duration of operation | during the study | duration of operation |
| implant position | during the study | implant position |
| implant fixation | during th study | implant fixation |
| perioperative technical errors | during the study | perioperative technical errors |
| Postoperative during hospital stay: | during the study | Postoperative during hospital stay: |
| number of patients and number of units transfused before hospital discharge | during the study | number of patients and number of units transfused before hospital discharge |
| total estimated blood loss | during the study | total estimated blood loss |
| Perioperative criteria : | during the study | Perioperative criteria : |
| skin problems | during the study | skin problems |
| duration of hospital stay | during the study | duration of hospital stay |
| Postoperative (3, 6 and 12 months): | during the study | Postoperative (3, 6 and 12 months): |
| Harris hip score, SF-36, evaluation of satisfaction and expectation | during the study | Harris hip score, SF-36, evaluation of satisfaction and expectation |
| Abduction strength, balance and gate | during the study | Abduction strength, balance and gate |
| Scar assessment | during the study | Scar assessment |
| complications | during the study | complications |
| postoperative pain | during the study | postoperative pain |
Countries
France
Contacts
Primary ContactPhilippe ANRACT, PU-PH
Outcome results
None listed