Osteoarthritis of the HipNCT02230657
A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
A study testing Same day discharge and Next day discharge in people with Osteoarthritis of the Hip, run by Rothman Institute Orthopaedics at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of the Hip
- What is being tested?
- Same day discharge and Next day discharge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Anderson Orthopaedic Clinic
Alexandria, Virginia, 22306
Rothman Institute
Philadelphia, Pennsylvania, 19107
About this study
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.
- Conditions
- Osteoarthritis of the Hip
- Being tested
- Same day discharge, Next day discharge
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same day dischargeProcedure or surgery
Next day dischargeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Same day Discharge | Active comparator | Not described Receives: Procedure: Same day discharge |
| Next day discharge | Active comparator | Not described Receives: Procedure: Next day discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Measured: Discharge through 30 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Collaborators
- The Anderson Orthopaedic Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230657
- Sponsor's protocol ID
- WHOZ01
- Status last verified
- Oct 2015
- First submitted
- 29 Aug 2014
- Last updated
- 21 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
- ClinicalTrials.gov ID
- NCT02230657
- Acronym / sponsor ID
- WHOZ01
- Conditions
- Osteoarthritis of the Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Collaborators
- The Anderson Orthopaedic Clinic
- Primary completion
- Aug 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same day Discharge | Active comparator | Procedure: Same day discharge |
| Next day discharge | Active comparator | Procedure: Next day discharge |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same day discharge | Procedure or surgery | Same day Discharge |
| Next day discharge | Procedure or surgery | Next day discharge |
Primary outcome
Patient Satisfaction
Time frame: Discharge through 30 days post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
Related trials for Osteoarthritis of the Hip
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Hip OA
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same day discharge and Next day discharge in people with Osteoarthritis of the Hip, run by Rothman Institute Orthopaedics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Discharge through 30 days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.