- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02230657
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
October 20, 2015 updated by: Rothman Institute Orthopaedics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Rothman Institute
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Virginia
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Alexandria, Virginia, United States, 22306
- The Anderson Orthopaedic Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Same day Discharge
|
|
|
Active Comparator: Next day discharge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient Satisfaction
Time Frame: Discharge through 30 days post-op
|
Discharge through 30 days post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
August 29, 2014
First Submitted That Met QC Criteria
August 29, 2014
First Posted (Estimate)
September 3, 2014
Study Record Updates
Last Update Posted (Estimate)
October 21, 2015
Last Update Submitted That Met QC Criteria
October 20, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WHOZ01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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