Total Joint ArthroplastyNCT01577823
Utility of Indwelling Catheter in Orthopaedic Patients Receiving Spinal Anesthesia
A study testing Foley Catheter in people with Total Joint Arthroplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical patients receiving spinal anesthesia. Study will track clinical outcomes, patient satisfaction and cost efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Joint Arthroplasty
- What is being tested?
- Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Elective orthopaedic surgical patients of all ages undergoing lower extremity adult reconstructive surgery with spinal anesthesia will be interviewed.
Who cannot join
- Patients are excluded from the study preoperatively with a history of prostate or urological surgery, renal failure, previous documented POUR, current indwelling catheter, or acute UTI.
Trial locations and contacts
1 site in 1 country.
About this study
A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical patients receiving spinal anesthesia. Study will track clinical outcomes, patient satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden without increasing postoperative urinary retention (POUR) incidence.
- Conditions
- Total Joint Arthroplasty
- Being tested
- Foley Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| No foley catheter | No intervention | Not described |
| Foley Catheter | Active comparator | Not described Receives: Device: Foley Catheter |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Joint ArthroplastyStudies 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577823
- Sponsor's protocol ID
- RIJPARU2011
- Status last verified
- Apr 2013
- First submitted
- 8 Dec 2011
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Indwelling Catheter in Orthopaedic Patients Receiving Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01577823
- Acronym / sponsor ID
- RIJPARU2011
- Conditions
- Total Joint Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- First posted
- 16 Apr 2012 (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.
A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical patients receiving spinal anesthesia. Study will track clinical outcomes, patient satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden without increasing postoperative urinary retention (POUR) incidence.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No foley catheter | No intervention | – |
| Foley Catheter | Active comparator | Device: Foley Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective orthopaedic surgical patients of all ages undergoing lower extremity adult reconstructive surgery with spinal anesthesia will be interviewed.
Key exclusion criteria (1 listed)
- Patients are excluded from the study preoperatively with a history of prostate or urological surgery, renal failure, previous documented POUR, current indwelling catheter, or acute UTI.
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 |
|---|---|---|
| Foley Catheter | Device | Foley Catheter |
Primary outcome
Not reported in the source record.
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 9 Apr 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley Catheter in people with Total Joint Arthroplasty, run by Rothman Institute Orthopaedics at 1 site 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 1 inclusion and 1 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 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 9 Apr 2013.