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Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital. (AHVACA)

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ClinicalTrials.gov Identifier: NCT03667339
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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

Condition or disease Intervention/treatment
Direct Anterior Total Hip Arthroplasty Procedure: Direct Anterior Total Hip Arthroplasty

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Study Type : Observational
Estimated Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital.
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : March 27, 2019
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
outpatients group
Patient schedulded to undergo outpatient Direct Anterior Total Hip Arthroplasty
Procedure: Direct Anterior Total Hip Arthroplasty
Direct Anterior Total Hip Arthroplasty

inpatients group
Patient schedulded to undergo inpatient Direct Anterior Total Hip Arthroplasty
Procedure: Direct Anterior Total Hip Arthroplasty
Direct Anterior Total Hip Arthroplasty




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients with Direct Anterior Total Hip Arthroplasty
Criteria

Inclusion Criteria:

  • 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

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

Exclusion Criteria:

  • 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
    • THA procedure for femoral neck fracture requiring
    • Additional operative technic needed
  • Adult safeguarding.

Exclusion criteria applies to all in and outpatients.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667339


Contacts
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Contact: Kristell COAT 2 99 28 91 91 ext +33 kristell.coat@chu-rennes.fr
Contact: Direction de la Recherche 2 99 28 25 55 ext + 33 drc@chu-rennes.fr

Locations
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France
CHU de Rennes Recruiting
Rennes, France, 35 033
Contact: Jean-Louis POLARD, MD         
Contact: Charlotte CRAMPET         
Principal Investigator: Jean-Louis POLARD, MD         
Sub-Investigator: Charlotte CRAMPET         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Jean Louis POLARD, MD Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03667339     History of Changes
Other Study ID Numbers: 35RC17_3084_AHVACA
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No