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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
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Osteoarthritis of the Hip

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 29, 2014
Last Updated
October 20, 2015
Sponsor
Rothman Institute Orthopaedics
Collaborators
The Anderson Orthopaedic Clinic
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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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