A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
Primary Purpose
Osteoarthritis of the Hip
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Same day discharge
Next day discharge
Sponsored by
About this trial
This is an interventional trial for Osteoarthritis of the Hip
Eligibility Criteria
Inclusion Criteria:
- Primary THA without acute hip fracture or prior hardware that would need to be removed at the time of surgery
- Unilateral THA
- Pre-operative Body Mass Index (BMI) < 40 kg/m2
- Age < 75 years at time of surgery
- Pre-operative hemoglobin > 10 g/dL if pre-operative hemoglobin data is available
- No history of cardiopulmonary disease that would necessitate inpatient monitoring after surgery
- Pre-operative ambulatory status does not require the use of a walker or wheelchair
- No chronic pre-operative opioid medication use or opioid addiction
- Assistance available at home after discharge from hospital
- No other condition or circumstance that would preclude rapid discharge from the hospital after surgery
- Subject's English proficiency allows understanding of study and Informed Consent
- Subject consented to participate in this study
Exclusion Criteria:
- Revision THA
- Bilateral THA
- Pre-operative BMI ≥ 40 kg/m2
- Age ≥ 75 at time of surgery
- Pre-operative hemoglobin ≤ 10 g/dL if pre-operative hemoglobin data is available
- History of cardiopulmonary disease requiring acute inpatient monitoring
- Pre-operative ambulatory status requiring the use of a walker or wheelchair
- Chronic pre-operative opioid medication use or opioid addiction
- Limited or no assistance available at home after discharge from hospital
- Any other condition or circumstance that would preclude rapid discharge from the hospital
- Subject not proficient in English
- Subject did not consent to participate in this study
Sites / Locations
- Rothman Institute
- The Anderson Orthopaedic Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Same day Discharge
Next day discharge
Arm Description
Outcomes
Primary Outcome Measures
Patient Satisfaction
Secondary Outcome Measures
Full Information
NCT ID
NCT02230657
First Posted
August 29, 2014
Last Updated
October 20, 2015
Sponsor
Rothman Institute Orthopaedics
Collaborators
The Anderson Orthopaedic Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02230657
Brief Title
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
Official Title
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
Collaborators
The Anderson Orthopaedic Clinic
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to identify differences in satisfaction, pain and length of stay between patients undergoing hip replacement who are discharged from the hospital on the day of surgery compared to patients who stay one night in the hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Hip
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Same day Discharge
Arm Type
Active Comparator
Arm Title
Next day discharge
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Same day discharge
Intervention Type
Procedure
Intervention Name(s)
Next day discharge
Primary Outcome Measure Information:
Title
Patient Satisfaction
Time Frame
Discharge through 30 days post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary THA without acute hip fracture or prior hardware that would need to be removed at the time of surgery
Unilateral THA
Pre-operative Body Mass Index (BMI) < 40 kg/m2
Age < 75 years at time of surgery
Pre-operative hemoglobin > 10 g/dL if pre-operative hemoglobin data is available
No history of cardiopulmonary disease that would necessitate inpatient monitoring after surgery
Pre-operative ambulatory status does not require the use of a walker or wheelchair
No chronic pre-operative opioid medication use or opioid addiction
Assistance available at home after discharge from hospital
No other condition or circumstance that would preclude rapid discharge from the hospital after surgery
Subject's English proficiency allows understanding of study and Informed Consent
Subject consented to participate in this study
Exclusion Criteria:
Revision THA
Bilateral THA
Pre-operative BMI ≥ 40 kg/m2
Age ≥ 75 at time of surgery
Pre-operative hemoglobin ≤ 10 g/dL if pre-operative hemoglobin data is available
History of cardiopulmonary disease requiring acute inpatient monitoring
Pre-operative ambulatory status requiring the use of a walker or wheelchair
Chronic pre-operative opioid medication use or opioid addiction
Limited or no assistance available at home after discharge from hospital
Any other condition or circumstance that would preclude rapid discharge from the hospital
Subject not proficient in English
Subject did not consent to participate in this study
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The Anderson Orthopaedic Clinic
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22306
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
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