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

NCT03667339 | Terminated

• 1 other identifier: 35RC17_3084_AHVACA
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Direct Anterior Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

outpatients group

Patient schedulded to undergo outpatient Direct Anterior Total Hip Arthroplasty

Procedure: Direct Anterior Total Hip Arthroplasty

inpatients group

Patient schedulded to undergo inpatient Direct Anterior Total Hip Arthroplasty

Procedure: Direct Anterior Total Hip Arthroplasty

Interventions

Direct Anterior Total Hip Arthroplasty PROCEDURE

Direct Anterior Total Hip Arthroplasty

inpatients group; outpatients group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with Direct Anterior Total Hip Arthroplasty

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35 033, France

Location

Study Officials

• Jean Louis POLARD, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: March 27, 2018
• Primary Completion: May 10, 2018
• Study Completion: May 10, 2018
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

FR (1)