Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-06-30
2023-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Blade vs Screw Intertrochanteric Hip Fracture Fixation Study
NCT03491189
Variations in Anesthesia Care for Hip Fracture Surgery
NCT02787031
Hemiarthroplasty Versus Total Hip Replacement for Intracapsular Hip Fractures
NCT02998359
Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty
NCT02998034
Impact of Fascia Iliaca Block in Hip Fracture Patients
NCT03525977
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this vanguard trial and proceed towards a multi-center trial.
Secondary objectives would be related to safety and patient activity that would be important endpoints for the definitive, large scale trial. These would include the following:
1. Is short term indwelling catheter use associated with reduced incidence of UTI compared to clean intermittent catheterization in patients with hip fracture.
2. How does patient experience compare between these two forms of treatment?
Eligible patients will be approached for consent at admission and, if willing to participate, will be randomized into Group A or Group B using a web-based, computer-generated randomization with permuted blocks of varying sizes.
Data Collection will include:
* Urinary symptoms at admission, pre-fracture
* Date and time of catheter insertion (indwelling or not)
* Date and time of surgery
* Type of anesthesia used
* Date and time of catheter removal
* Number of catheterizations performed during hospital stay
* Type of Antibiotic cover during per-operative period (typically 3 doses provided perioperatively)
A clinical research coordinator (CRC) will oversee study recruitment and assess number of study participants to the total number of patients admitted with a hip fracture which will allow for documentation of ability to recruit into the study. Furthermore, the CRC will prospectively record each patent's journey to assess whether enrolled patients are receiving the treatment they are randomized to. All enrolled patients will be asked to fill in a patient satisfaction score that has been in use already at our institution.
A CRC, blinded to the arm patients were randomized to, will be responsible for recording all outcome measures of interest prospectively in the study's database from the participant's electronic medical records. Validity of data extraction will be tested for a randomly selected 10% of the cohort by a second evaluator (CRC not previously involved in the study).
Data analyses will include:
Descriptive Statistics: Given the feasibility purpose of the vanguard trial, descriptive statistics will be used to summarize demographics and baseline prognostic factors of participants allocated to the two trial arms.
Analysis of Primary Outcome: Our primary endpoint is the rate of enrolment to ensure the ability to undertake a larger multi-centered trial. An average rate of 10 patients/month or greater will be considered as ideal for establishing feasibility. An enrollment of less than 5 patients/month will likely jeopardize the ability to feasibly recruit for the larger trial. Whereas, average monthly enrolment of 5 to 10 patients will require a re-evaluation of our recruitment strategy, intervention specifications, and/or eligibility criteria to improve enrolment.
Analysis of Secondary Outcomes: Given the vanguard nature of this trial, the investigators will not undertake inferential analyses of our secondary outcomes but rather these patients will be carried forward into the larger trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Indwelling
Foley catheterization upon admission and removed the morning following surgery.
Indwelling Catheter
Patients in the experimental group will receive foley catheter upon admission, aseptically. The catheter will be discontinued on the morning following surgery. At TOH most (\>75%) hip fractures are treated within 48 hours of admission and 95% within 72 hours and hence the indwelling catheter is likely to stay in place for 3-4 days.
Intermittent
Intermittent catheterization when post-void residual volume is greater than 400 mL.
Intermittent Catheterization
Patients randomized to the intermittent catheterization group will have their PVR monitored every 8 hours pre-operatively. If PVR\>400 mL, an intermittent catheter will be used. If PVR\> 400 mL greater than 3 times pre-operatively, an indwelling catheter will be placed the fourth time. The indwelling catheter will be removed the morning of post-op day 1.
It is expected that a small percentage of patients in either group will not have a PVR\>400 mL preoperatively.
These patients will not be catheterized but will remain in the study. Post-operatively, both treatment groups will have their PVR monitored for 24 hours, or until PVR is less than 200 mL. If PVR\>400 mL and the patient is not able to void further, intermittent catheterization will be done every six hours as needed. If post-operative PVR\>400 mL greater than 3 times post-operatively, an indwelling catheter will be placed the fourth time.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Indwelling Catheter
Patients in the experimental group will receive foley catheter upon admission, aseptically. The catheter will be discontinued on the morning following surgery. At TOH most (\>75%) hip fractures are treated within 48 hours of admission and 95% within 72 hours and hence the indwelling catheter is likely to stay in place for 3-4 days.
Intermittent Catheterization
Patients randomized to the intermittent catheterization group will have their PVR monitored every 8 hours pre-operatively. If PVR\>400 mL, an intermittent catheter will be used. If PVR\> 400 mL greater than 3 times pre-operatively, an indwelling catheter will be placed the fourth time. The indwelling catheter will be removed the morning of post-op day 1.
It is expected that a small percentage of patients in either group will not have a PVR\>400 mL preoperatively.
These patients will not be catheterized but will remain in the study. Post-operatively, both treatment groups will have their PVR monitored for 24 hours, or until PVR is less than 200 mL. If PVR\>400 mL and the patient is not able to void further, intermittent catheterization will be done every six hours as needed. If post-operative PVR\>400 mL greater than 3 times post-operatively, an indwelling catheter will be placed the fourth time.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥50 years
* Operative treatment planned
* Admitted under Orthopaedic Surgery
* Willing and able to sign consent (substitute decision maker)
Exclusion Criteria
* Polytrauma
* Multiple fractures of the lower limbs
* Previous lower urinary tract surgery
* Known (past or current) urogenital cancer (prostate, bladder)
* Urinary tract infection prior to randomization
* Indwelling catheter present on admission (chronic or placed at previous acute setting)
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Ottawa Hospital
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
George Grammatopoulos, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Steven Papp, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Ottawa Hospital
Ottawa, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Health Quality Ontario, M.o.H.a.L.-T.C., Quality Based Procedures Clinical Handbook for Hip Fracture. 2013.
Dodd AC, Bulka C, Jahangir A, Mir HR, Obremskey WT, Sethi MK. Predictors of 30-day mortality following hip/pelvis fractures. Orthop Traumatol Surg Res. 2016 Oct;102(6):707-10. doi: 10.1016/j.otsr.2016.05.016. Epub 2016 Aug 3.
Skelly JM, Guyatt GH, Kalbfleisch R, Singer J, Winter L. Management of urinary retention after surgical repair of hip fracture. CMAJ. 1992 Apr 1;146(7):1185-9.
Smith NK, Albazzaz MK. A prospective study of urinary retention and risk of death after proximal femoral fracture. Age Ageing. 1996 Mar;25(2):150-4. doi: 10.1093/ageing/25.2.150.
Hedstrom M, Grondal L, Ahl T. Urinary tract infection in patients with hip fractures. Injury. 1999 Jun;30(5):341-3. doi: 10.1016/s0020-1383(99)00094-7.
Kamdar A, Yahya A, Thangaraj L. Retrospective observational study of the incidence of short-term indwelling urinary catheters in elderly patients with neck of femur fractures. Geriatr Gerontol Int. 2009 Jun;9(2):131-4. doi: 10.1111/j.1447-0594.2008.00490.x.
Schneider MA. Prevention of catheter-associated urinary tract infections in patients with hip fractures through education of nurses to specific catheter protocols. Orthop Nurs. 2012 Jan-Feb;31(1):12-8. doi: 10.1097/NOR.0b013e3182419619.
Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
Thomas S, Harris N, Dobransky J, Grammatopoulos G, Gartke K, Liew A, Papp S. Urinary catheter use in patients with hip fracture: Are current guidelines appropriate? A retrospective review. Can J Surg. 2021 Nov 25;64(6):E630-E635. doi: 10.1503/cjs.014620. Print 2021 Nov-Dec.
Excellence, N.I.f.H.a.C., Hip fracture: management. 2011.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20220067-01H
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.