Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement (ANRACT)
Primary Purpose
Osteoarthritis of the Hip
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
-preoperative education and total hip replacement
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Hip focused on measuring Osteoarthritis,, hip replacement,, education,, randomized controlled trial,, mini-invasive surgery
Eligibility Criteria
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
Sites / Locations
- Hopital CochinRecruiting
Outcomes
Primary Outcome Measures
Time to reach functional independence at hospital discharge
Time to reach functional independence at hospital discharge
Secondary Outcome Measures
Perioperative criteria :
Perioperative criteria :
estimated blood loss
estimated blood loss
duration of operation
duration of operation
implant position
implant position
implant fixation
implant fixation
perioperative technical errors
perioperative technical errors
Postoperative during hospital stay:
Postoperative during hospital stay:
number of patients and number of units transfused before hospital discharge
number of patients and number of units transfused before hospital discharge
total estimated blood loss
total estimated blood loss
postoperative pain
postoperative pain
skin problems
skin problems
duration of hospital stay
duration of hospital stay
Postoperative (3, 6 and 12 months):
Postoperative (3, 6 and 12 months):
Harris hip score, SF-36, evaluation of satisfaction and expectation
Harris hip score, SF-36, evaluation of satisfaction and expectation
Abduction strength, balance and gate
Abduction strength, balance and gate
Scar assessment
Scar assessment
complications
complications
Full Information
NCT ID
NCT00449228
First Posted
March 18, 2007
Last Updated
June 4, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Cochin Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00449228
Brief Title
Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement
Acronym
ANRACT
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 Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Cochin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Hip
Keywords
Osteoarthritis,, hip replacement,, education,, randomized controlled trial,, mini-invasive surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
215 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
-preoperative education and total hip replacement
Intervention Description
-preoperative education and total hip replacement
Primary Outcome Measure Information:
Title
Time to reach functional independence at hospital discharge
Description
Time to reach functional independence at hospital discharge
Time Frame
during de study
Secondary Outcome Measure Information:
Title
Perioperative criteria :
Description
Perioperative criteria :
Time Frame
during the study
Title
estimated blood loss
Description
estimated blood loss
Time Frame
during the study
Title
duration of operation
Description
duration of operation
Time Frame
during the study
Title
implant position
Description
implant position
Time Frame
during the study
Title
implant fixation
Description
implant fixation
Time Frame
during th study
Title
perioperative technical errors
Description
perioperative technical errors
Time Frame
during the study
Title
Postoperative during hospital stay:
Description
Postoperative during hospital stay:
Time Frame
during the study
Title
number of patients and number of units transfused before hospital discharge
Description
number of patients and number of units transfused before hospital discharge
Time Frame
during the study
Title
total estimated blood loss
Description
total estimated blood loss
Time Frame
during the study
Title
postoperative pain
Description
postoperative pain
Time Frame
during the study
Title
skin problems
Description
skin problems
Time Frame
during the study
Title
duration of hospital stay
Description
duration of hospital stay
Time Frame
during the study
Title
Postoperative (3, 6 and 12 months):
Description
Postoperative (3, 6 and 12 months):
Time Frame
during the study
Title
Harris hip score, SF-36, evaluation of satisfaction and expectation
Description
Harris hip score, SF-36, evaluation of satisfaction and expectation
Time Frame
during the study
Title
Abduction strength, balance and gate
Description
Abduction strength, balance and gate
Time Frame
during the study
Title
Scar assessment
Description
Scar assessment
Time Frame
during the study
Title
complications
Description
complications
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe ANRACT, PU-PH
Phone
+33(0)1 58 41 30 98
Email
philippe.anract@cch.ap-hop-paris.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe ANRACT, PU-PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe ANRACT, PU-PH
Phone
+33(0)1 58 41 30 98
Email
philippe.anract@cch.ap-hop-paris.fr
12. IPD Sharing Statement
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Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement
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