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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03667339
Other study ID # 35RC17_3084_AHVACA
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 27, 2018
Est. completion date May 10, 2018

Study information

Verified date April 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date May 10, 2018
Est. primary completion date May 10, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Direct Anterior Total Hip Arthroplasty

Intervention

Procedure:
Direct Anterior Total Hip Arthroplasty
Direct Anterior Total Hip Arthroplasty

Locations

Country Name City State
France CHU de Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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