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

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 Overview

• Status: Terminated
• Conditions: Direct Anterior Total Hip Arthroplasty
• Intervention / Treatment: Procedure: Direct Anterior Total Hip Arthroplasty

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35 033
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with Direct Anterior Total Hip Arthroplasty

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	45 days before surgery

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Jean Louis POLARD, MD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Actual): May 10, 2018
• Study Completion (Actual): May 10, 2018

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 35RC17_3084_AHVACA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No