Osteoarthritis of the HipPhase 3ANRACTNCT00449228
Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement
A Phase 3 study testing -preoperative education and total hip replacement in people with Osteoarthritis of the Hip, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Hip
- What is being tested?
- -preoperative education and total hip replacement
- Type of treatment
- Surgery or procedure
- How many people
- 215 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis of the hip
- avascular necrosis of the hip
- patient between 40 and 90 years old (included)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Cochin
Paris, 75014
Philippe ANRACT, PU-PH, +33(0)1 58 41 30 98, philippe.anract@cch.ap-hop-paris.fr
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis of the Hip
- Being tested
- -preoperative education and total hip replacement
- Keywords
- Osteoarthritis,, hip replacement,, education,, randomized controlled trial,, mini-invasive surgery
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
-preoperative education and total hip replacementProcedure or surgery
-preoperative education and total hip replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach functional independence at hospital discharge
Time to reach functional independence at hospital discharge
Measured: during de study
Secondary outcomes (17)
Perioperative criteria :
Perioperative criteria :
Measured: during the study
estimated blood loss
estimated blood loss
Measured: during the study
duration of operation
duration of operation
Measured: during the study
implant position
implant position
Measured: during the study
implant fixation
implant fixation
Measured: during th study
perioperative technical errors
perioperative technical errors
Measured: during the study
Postoperative during hospital stay:
Postoperative during hospital stay:
Measured: 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
Measured: during the study
total estimated blood loss
total estimated blood loss
Measured: during the study
postoperative pain
postoperative pain
Measured: during the study
skin problems
skin problems
Measured: during the study
duration of hospital stay
duration of hospital stay
Measured: during the study
Postoperative (3, 6 and 12 months):
Postoperative (3, 6 and 12 months):
Measured: during the study
Harris hip score, SF-36, evaluation of satisfaction and expectation
Harris hip score, SF-36, evaluation of satisfaction and expectation
Measured: during the study
Abduction strength, balance and gate
Abduction strength, balance and gate
Measured: during the study
Scar assessment
Scar assessment
Measured: during the study
complications
complications
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the HipStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Cochin Hospital
- Responsible party
- Sponsor
- Investigators
- Philippe ANRACT, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449228
- Sponsor's protocol ID
- P051040
- Acronym
- ANRACT
- Status last verified
- Mar 2007
- First submitted
- 18 Mar 2007
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00449228
- Acronym / sponsor ID
- ANRACT / P051040
- Conditions
- Osteoarthritis of the Hip
- Keywords
- Osteoarthritis,, hip replacement,, education,, randomized controlled trial,, mini-invasive surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Cochin Hospital
- Study start
- Apr 2007
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 20 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- osteoarthritis of the hip
- avascular necrosis of the hip
- patient between 40 and 90 years old (included)
Key exclusion criteria (6 listed)
- history of previous hip operation (bone)
- patient >90 or < 40
- inflammatory arthritis
- important proximal femur or acetabular deformity
- complete functional independence not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| -preoperative education and total hip replacement-preoperative education and total hip replacement | Procedure or surgery | – |
Primary outcome
Time to reach functional independence at hospital discharge
Time frame: during de study
Time to reach functional independence at hospital discharge
17 secondary outcomes
Perioperative criteria :
Time frame: during the study
estimated blood loss
Time frame: during the study
duration of operation
Time frame: during the study
implant position
Time frame: during the study
implant fixation
Time frame: during th study
perioperative technical errors
Time frame: during the study
Postoperative during hospital stay:
Time frame: during the study
number of patients and number of units transfused before hospital discharge
Time frame: during the study
total estimated blood loss
Time frame: during the study
postoperative pain
Time frame: during the study
skin problems
Time frame: during the study
duration of hospital stay
Time frame: during the study
Postoperative (3, 6 and 12 months):
Time frame: during the study
Harris hip score, SF-36, evaluation of satisfaction and expectation
Time frame: during the study
Abduction strength, balance and gate
Time frame: during the study
Scar assessment
Time frame: during the study
complications
Time frame: during the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
Related trials for Osteoarthritis of the Hip
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe ANRACT, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing -preoperative education and total hip replacement in people with Osteoarthritis of the Hip, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe ANRACT, PU-PH (+33(0)1 58 41 30 98, philippe.anract@cch.ap-hop-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach functional independence at hospital discharge (time frame: during de study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.