Direct Anterior Total Hip ArthroplastyAHVACANCT03667339
Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital.
An observational study of Direct Anterior Total Hip Arthroplasty, run by Rennes University Hospital at 1 site in France.
Trial summary
The main objective is to show that cumulative length of stay over the first 45 post operative days (i.e. : primary length of stay and readmission) is significantly lower in the outpatients group than in the inpatients group Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Direct Anterior Total Hip Arthroplasty
- What is being tested?
- Direct Anterior Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2018to 10 May 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients with Direct Anterior Total Hip Arthroplasty
Who may be able to join
- Unilateral primary total hip arthroplasty for hip osteoarthritis, primary or secondary osteoarthritis (dysplasia or post-traumatic) or osteonecrosis
- Good enough understanding of outpatient management and patient adherence to post-operative instructions
- Sufficient patient complicance to medical orders
- Living and hygiene conditions, at least, equivalent to the ones the hospital provides
- To be of age
- Non opposition to the protocole participation
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- Outpatients group :
- Patient schedulded to undergo outpatient THA
- Inpatients group :
- Patient schedulded to undergo inpatient THA because of not fiting the following items :
- Less than an hour distance of a Health Center that provides appropriate care with regard to the surgery
- Rapid access to a phone
- Designated driver and caretaker available (at least the first night after discharge from the hospital) after the procedure Or turning down outpatient THA
Who cannot join
- Anaesthetic point of view :
- ASA physical status ≥ 3 and : unstabilize disease with appropriate treatment or lack of preoperative mutual agreement between anesthesiologist and surgeon or not inconsiderable interaction between the operation and the disease or its treatment
- Pre-operative Hb < 12 (♀) < 13 (♂) g/L (NB : no Hb control before discharge except if excessive blood loss ; Hb < 10g/L contraindicates outpatient surgery)
- Opioid chronic pre-operative therapy or opioid addiction
- Surgical point of view :
- Ambulatory pre-operative status requiring use of two crutches or walking frame / distance walked < 30 m
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- THA procedure for femoral neck fracture requiring
- Additional operative technic needed
- Adult safeguarding.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to show that cumulative length of stay over the first 45 post operative days (i.e. : primary length of stay and readmission) is significantly lower in the outpatients group than in the inpatients group
- Conditions
- Direct Anterior Total Hip Arthroplasty
- Being tested
- Direct Anterior Total Hip Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Anterior Total Hip ArthroplastyProcedure or surgery
Direct Anterior Total Hip Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| outpatients group | Patient schedulded to undergo outpatient Direct Anterior Total Hip Arthroplasty Receives: Procedure: Direct Anterior Total Hip Arthroplasty | |
| inpatients group | Patient schedulded to undergo inpatient Direct Anterior Total Hip Arthroplasty Receives: Procedure: Direct Anterior Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative lenght of stay
Cumulative lenght of stay ( ie : the sum of the days of hospitalization corresponding to the initial hospitalization and readmissions if there are any)
Measured: 45 days before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start27 Mar 2018
- Primary completion10 May 2018
- Study completion10 May 2018
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Anterior Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Louis POLARD, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667339
- Sponsor's protocol ID
- 35RC17_3084_AHVACA
- Acronym
- AHVACA
- Status last verified
- Apr 2023
- First submitted
- 10 Sep 2018
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital.
- ClinicalTrials.gov ID
- NCT03667339
- Acronym / sponsor ID
- AHVACA / 35RC17_3084_AHVACA
- Conditions
- Direct Anterior Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 12 Sep 2018 (actual)
- 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.
The main objective is to show that cumulative length of stay over the first 45 post operative days (i.e. : primary length of stay and readmission) is significantly lower in the outpatients group than in the inpatients group
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| outpatients group | – | Procedure: Direct Anterior Total Hip ArthroplastyPatient schedulded to undergo outpatient Direct Anterior Total Hip Arthroplasty |
| inpatients group | – | Procedure: Direct Anterior Total Hip ArthroplastyPatient schedulded to undergo inpatient Direct Anterior Total Hip Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with Direct Anterior Total Hip Arthroplasty
Key inclusion criteria (13 listed)
- Unilateral primary total hip arthroplasty for hip osteoarthritis, primary or secondary osteoarthritis (dysplasia or post-traumatic) or osteonecrosis
- Good enough understanding of outpatient management and patient adherence to post-operative instructions
- Sufficient patient complicance to medical orders
- Living and hygiene conditions, at least, equivalent to the ones the hospital provides
- To be of age
Key exclusion criteria (9 listed)
- Anaesthetic point of view :
- Surgical point of view :
- Adult safeguarding.
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 |
|---|---|---|
| Direct Anterior Total Hip ArthroplastyDirect Anterior Total Hip Arthroplasty | Procedure or surgery | inpatients group, outpatients group |
Primary outcome
Cumulative lenght of stay
Time frame: 45 days before surgery
Cumulative lenght of stay ( ie : the sum of the days of hospitalization corresponding to the initial hospitalization and readmissions if there are any)
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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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.
Jean Louis POLARD, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Direct Anterior Total Hip Arthroplasty, run by Rennes University Hospital 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 13 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Apr 2023. 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.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative lenght of stay (time frame: 45 days before surgery). 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 13 Apr 2023.