A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach

Osteoarthritis of the Hip Clinical Trial

Official title:

A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230657
• Other study ID #: WHOZ01
• Status: Completed
• Phase: N/A
• First received: August 29, 2014
• Last updated: October 20, 2015

Study information

• Verified date: October 2015
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Osteoarthritis of the Hip
• Osteoarthritis, Hip

Intervention

Procedure:
• Same day discharge

• Next day discharge

Locations

Country	Name	City	State
United States	The Anderson Orthopaedic Clinic	Alexandria	Virginia
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics	The Anderson Orthopaedic Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction		Discharge through 30 days post-op	No