Osteoarthritis, HipNCT04120324
Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
An observational study of Osteoarthritis, Hip and Arthroplasty Complications, run by University of British Columbia at 1 site in Canada.
Trial summary
Amongst patients who are discharged home from hospital on the same day as their elective Primary Total Hip Arthroplasty, the Investigators seek to quantify the incidence of return to hospital within 30 days of surgery for assessment \&/or treatment of surgical related problems or complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip, Arthroplasty Complications, Complication of Surgical Procedure
- What is being tested?
- Eligible for Same Day Discharge, Primary Single Joint Total Hip Arthroplasty and Discharge Same Day
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2018to 30 Jan 2020
- Phase
- Observational
- 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
Study population: Patients with hip joint pathology being booked for elective joint replacement by Orthopedics and earmarked by the surgeon as potentially Same Day Discharge eligible at the time of surgical booking.
Who may be able to join
- Surgical Team submits patient as potentially eligible for Same Day Discharge at the time of surgical booking.
Who cannot join
- Excluded if the patient never has a surgical procedure despite surgical booking and preoperative assessment. All patients must undergo surgery to be included.
Trial locations and contacts
1 site in 1 country.
About this study
Amongst patients who are discharged home from hospital on the same day as their elective Primary Total Hip Arthroplasty, the Investigators seek to quantify the incidence of return to hospital within 30 days of surgery for assessment \&/or treatment of surgical related problems or complications. This incidence rate will be compared to a cohort of patients who are not discharged on the same day as their Primary Total Hip Arthroplasty. The Investigators wish to know if the incidence of 30 day return to hospital is significantly different between these two groups of patients.
Read the detailed description
At UBC Hospital, a program to facilitate same day discharge of elective Primary Total Hip Arthroplasty patients was developed in 2017/18. The program is called the "Short Term Accelerated Recovery" (STAR) program, and patients within the program are called "STAR Patients." The first patient in the program had their surgery on Oct 15, 2018, and the program has been running ever since.
The STAR process begins by the attending surgeon (there are 5 Arthroplasty Surgeons at UBC involved in this program) earmarking a patient as a potential same day discharge candidate based on their assessment of the patient. Following this, the patient is assessed by both Physiotherapy and Anesthesia to either confirm or reject their STAR eligibility.
STAR eligibility criteria can be divided into both Social and Clinical requirements. The Social requirements are for the patient to live within an hour's drive of the Vancouver General Hospital (VGH) Emergency Room, and that they have a support person (either family or friend) that will stay with them in their home for at least the first 24 hours following surgery and can be called upon at any time subsequent to help in caring for the patient or facilitating their return to hospital if needed.
Strict Clinical Requirements to be STAR Eligible were established by the Dept of Anesthesia based on best evidence and expert opinion. These criteria were used to establish a "Check-List" of items to ensure all eligibility criteria are met. Items on this Checklist included the correct Surgical Procedure, patient age ≤ 75, Pre-Anestheic Risk Assessment, and Lab Result Reviews.
Patients initially enrolled in the STAR Program by their Orthopedic Surgeon at the time of surgical booking [presently a total of 87 patients] could end up in one of three possible cohorts following their surgery:
- The patient was deemed STAR eligible preoperatively, had their hip replacement surgery and went home the same day as their surgery [presently 24 patients].
- The patient was deemed STAR eligible preoperatively, had their hip replacement surgery but were NOT sent home same day as their surgery for failing to meet criteria for safe discharge and thus staying a minimum of one overnight in hospital [presently 24 patients].
- The patient was deemed NOT eligible for STAR prior to their surgery, and therefore stayed at least one night in hospital following their surgery [presently 39 patients].
Thus far, the STAR program has failed to adequately assess the incidence of 30 day post-surgical complications. Despite an infrastructure to attain this quality assessment being in place by way of a postoperative survey sent to patients via Email, return of these surveys has been minimal thus far. As a result, the Investigators are seeking a more robust and comprehensive search of postoperative hospital encounters for surgically related problems amongst these patients by way of chart review.
This project is a retrospective cohort quality assurance chart review study. Given that the criteria for enrollment in STAR is site specific and has not been established before, this project is designed to be both a preliminary safety assessment and also able to inform future prospective studies on the program's safety for potential sample sizes needed for such assessments. As well, the study would also expose the potential for a higher than expected return to hospital for same day discharge patients which may not otherwise have been known.
A log of all patients initially enrolled as potentially "STAR Eligible" by their surgeon has been maintained by the PI. Using this list of patients, the following sequence of events will occur to assess each for hospital encounters for surgical related problems, inquiries or complications during the 30 days immediately following surgery:
- All patient's charts, both paper records at VGH and UBC Hospital, as well as electronic charts within the BC Care Connect network that can show encounters at hospitals throughout the province of British Columbia, will be retained by Research Personnel.
- Charts will be perused for any hospital encounters during the 30 days immediately post the date of surgery.
- If encounters are found, the specific nature of the encounter will be ascertained.
- Study personnel will decide, based on the clinical presentation and documentation available on the patient's chart, whether the encounter may be considered a "surgically related problem, inquiry or complication". Examples of surgically related problems include (but are not limited to) wound or surgical site infection, deep vein thrombosis, pneumonia, urinary tract infection, pain issues as a result of having surgery, failure or concerns for the function of the new prosthesis, trauma or falls as a result of reduced mobility following surgery.
- Some encounters may be obvious as surgically related problems - eg. concerns for a possible wound infection at the surgical site. Others may be less obviously surgically related depending on the presentation - eg. sepsis or organ failure. It will be left to the PI to invigilate and decide whether the reasons for hospital encounter are or are not obviously surgical in nature. For those deemed not obviously surgical, opinion will be sought from 2 independent specialists in Perioperative Internal Medicine on whether they feel the encounters to be related to the patient's hip arthroplasty. Reviewers will be blinded to each other's opinions. If both Reviewers agree that the encounter was for a surgically related problem then it will be tallied as such. If there is disagreement or both believe the problem to not be surgically related then it will not be considered a surgically related hospital encounter.
- If a hospital encounter is found amongst the patient's records, but no documentation about the nature of the encounter is available, then the Patient's Orthopedic Surgeon will be contacted to see if they retain any record of postoperative up to 30 day encounters and what the nature of the encounter was. Patients will NOT be contacted for the purpose of this QA study.
Approval for this study has been attained from the following:
- University of British Columbia Research Ethics Board.
- Vancouver Coastal Health Research Institute.
Study Personnel who will be retaining and invigilating patient charts will be the PI - a staff Anesthesiologist, a Resident in the UBC Anesthesiology Post-Graduate Program, and a UBC Medical Student.
It is anticipated that between 100 and 150 patients will have been through the STAR process at the time retrospective chart review begins.
- Conditions
- Osteoarthritis, Hip, Arthroplasty Complications, Complication of Surgical Procedure, Perioperative Complication
- Being tested
- Eligible for Same Day Discharge, Primary Single Joint Total Hip Arthroplasty, Discharge Same Day
- Keywords
- complication, surgery
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eligible for Same Day DischargeOther
Preoperative Physiotherapy and Anesthesia Criteria met.
Primary Single Joint Total Hip ArthroplastyProcedure or surgery
Total Hip Replacement Surgery
Discharge Same DayOther
Postoperative criteria for Same Day Discharge met.
| Study group | Role | What they receive |
|---|---|---|
| Eligible & Discharged Same Day | Surgeon earmarks patient as potentially eligible for Same Day Discharge. Preoperative Assessment by Physiotherapy and Anesthesia confirms patient is Same Day Discharge eligible. Patient undergoes Primary Single Joint Total Hip Arthroplasty and is discharged home on the day of surgery. Receives: Other: Eligible for Same Day Discharge; Procedure: Primary Single Joint Total Hip Arthroplasty; Other: Discharge Same Day | |
| Eligible but NOT Discharged Same Day | Surgeon earmarks patient as potentially eligible for Same Day Discharge. Preoperative Assessment by Physiotherapy and Anesthesia confirms patient is Same Day Discharge eligible. Patient undergoes Primary Single Joint Total Hip Arthroplasty but is NOT discharged home on the same day as the surgery, and remains in hospital for a minimum of one night following surgery. Reasons for not being discharged same day include potential problems related to Surgery (eg. complication), Anesthesia (eg. prolonged effect), or patient factors (egs. pain, nausea, mobility difficulties, etc.). Receives: Other: Eligible for Same Day Discharge; Procedure: Primary Single Joint Total Hip Arthroplasty | |
| Not Eligible for Discharge Same Day | Surgeon earmarks patient as potentially eligible for Same Day Discharge. Preoperative Assessment by Physiotherapy and/or Anesthesia deems the patient to NOT be eligible for Same Day Discharge. The patient undergoes Primary Single Joint Total Hip Arthroplasty and remains for a minimum of one overnight in hospital following hip replacement surgery. Receives: Procedure: Primary Single Joint Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who return to hospital for assessment and/or treatment of a surgical related problem or complication following Primary Total Hip Arthroplasty.
Patient records will be reviewed for hospital encounters within 30 days of their surgical procedure. If encounters are found within this timeframe, it will be discerned whether the encounter is for a surgically related problem or complication. Examples of surgically related problems include (but are not limited to) wound or surgical site infection, deep vein thrombosis, pulmonary embolism, pneumonia, urinary tract infection, pain issues as a result of having surgery, failure or concerns for the function of the new prosthesis, trauma or falls as a result of reduced mobility following surgery.
Measured: Within 30 days of elective Total Hip Arthroplasty surgery
Secondary outcomes (1)
The number of Patients who return to hospital for assessment and/or treatment of surgical related problems or complications following Primary Total Hip Arthroplasty.
Patient records will be reviewed for hospital encounters within 7 days of their surgical procedure. If encounters are found within this timeframe, it will be discerned whether the encounter is for a surgically related problem or complication in the same fashion as for the Primary Outcome Measure.
Measured: Within 7 days of elective Total Hip Arthroplasty surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start15 Oct 2018
- Primary completion11 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald J Young, MD, FRCPC, University of British Columbia
- Investigators
- Donald J Young, MD, Principal investigator, University of British Columbia, Vancouver Coastal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120324
- Sponsor's protocol ID
- H19-02526
- Status last verified
- Apr 2020
- First submitted
- 29 Sep 2019
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meneghini R, Gibson W, Halsey D, Padgett D, Berend K, Della Valle CJ. The American Association of Hip and Knee Surgeons, Hip Society, Knee Society, and American Academy of Orthopaedic Surgeons Position Statement on Outpatient Joint Replacement. J Arthroplasty. 2018 Dec;33(12):3599-3601. doi: 10.1016/j.arth.2018.10.029. No abstract available.
PubMed 30449455Poitras S, Wood KS, Savard J, Dervin GF, Beaule PE. Predicting early clinical function after hip or knee arthroplasty. Bone Joint Res. 2015 Sep;4(9):145-51. doi: 10.1302/2046-3758.49.2000417.
PubMed 26336897Ziemba-Davis M, Caccavallo P, Meneghini RM. Outpatient Joint Arthroplasty-Patient Selection: Update on the Outpatient Arthroplasty Risk Assessment Score. J Arthroplasty. 2019 Jul;34(7S):S40-S43. doi: 10.1016/j.arth.2019.01.007. Epub 2019 Jan 15.
PubMed 30738619Meneghini RM, Ziemba-Davis M, Ishmael MK, Kuzma AL, Caccavallo P. Safe Selection of Outpatient Joint Arthroplasty Patients With Medical Risk Stratification: the "Outpatient Arthroplasty Risk Assessment Score". J Arthroplasty. 2017 Aug;32(8):2325-2331. doi: 10.1016/j.arth.2017.03.004. Epub 2017 Mar 14.
PubMed 28390881Sher A, Keswani A, Yao DH, Anderson M, Koenig K, Moucha CS. Predictors of Same-Day Discharge in Primary Total Joint Arthroplasty Patients and Risk Factors for Post-Discharge Complications. J Arthroplasty. 2017 Sep;32(9S):S150-S156.e1. doi: 10.1016/j.arth.2016.12.017. Epub 2016 Dec 22.
PubMed 28089186Kort NP, Bemelmans YFL, van der Kuy PHM, Jansen J, Schotanus MGM. Patient selection criteria for outpatient joint arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2668-2675. doi: 10.1007/s00167-016-4140-z. Epub 2016 Apr 22.
PubMed 27106923
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04120324
- Acronym / sponsor ID
- H19-02526
- Conditions
- Osteoarthritis, Hip, Arthroplasty Complications, Complication of Surgical Procedure, Perioperative Complication
- Keywords
- complication, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 9 Oct 2019 (actual)
- 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.
Amongst patients who are discharged home from hospital on the same day as their elective Primary Total Hip Arthroplasty, the Investigators seek to quantify the incidence of return to hospital within 30 days of surgery for assessment \&/or treatment of surgical related problems or complications. This incidence rate will be compared to a cohort of patients who are not discharged on the same day as their Primary Total Hip Arthroplasty. The Investigators wish to know if the incidence of 30 day return to hospital is significantly different between these two groups of patients.
Detailed description
At UBC Hospital, a program to facilitate same day discharge of elective Primary Total Hip Arthroplasty patients was developed in 2017/18. The program is called the "Short Term Accelerated Recovery" (STAR) program, and patients within the program are called "STAR Patients." The first patient in the program had their surgery on Oct 15, 2018, and the program has been running ever since.
The STAR process begins by the attending surgeon (there are 5 Arthroplasty Surgeons at UBC involved in this program) earmarking a patient as a potential same day discharge candidate based on their assessment of the patient. Following this, the patient is assessed by both Physiotherapy and Anesthesia to either confirm or reject their STAR eligibility.
STAR eligibility criteria can be divided into both Social and Clinical requirements. The Social requirements are for the patient to live within an hour's drive of the Vancouver General Hospital (VGH) Emergency Room, and that they have a support person (either family or friend) that will stay with them in their home for at least the first 24 hours following surgery and can be called upon at any time subsequent to help in caring for the patient or facilitating their return to hospital if needed.
Strict Clinical Requirements to be STAR Eligible were established by the Dept of Anesthesia based on best evidence and expert opinion. These criteria were used to establish a "Check-List" of items to ensure all eligibility criteria are met. Items on this Checklist included the correct Surgical Procedure, patient age ≤ 75, Pre-Anestheic Risk Assessment, and Lab Result Reviews.
Patients initially enrolled in the STAR Program by their Orthopedic Surgeon at the time of surgical booking [presently a total of 87 patients] could end up in one of three possible cohorts following their surgery:
- The patient was deemed STAR eligible preoperatively, had their hip replacement surgery and went home the same day as their surgery [presently 24 patients].
- The patient was deemed STAR eligible preoperatively, had their hip replacement surgery but were NOT sent home same day as their surgery for failing to meet criteria for safe discharge and thus staying a minimum of one overnight in hospital [presently 24 patients].
- The patient was deemed NOT eligible for STAR prior to their surgery, and therefore stayed at least one night in hospital following their surgery [presently 39 patients].
Thus far, the STAR program has failed to adequately assess the incidence of 30 day post-surgical complications. Despite an infrastructure to attain this quality assessment being in place by way of a postoperative survey sent to patients via Email, return of these surveys has been minimal thus far. As a result, the Investigators are seeking a more robust and comprehensive search of postoperative hospital encounters for surgically related problems amongst these patients by way of chart review.
This project is a retrospective cohort quality assurance chart review study. Given that the criteria for enrollment in STAR is site specific and has not been established before, this project is designed to be both a preliminary safety assessment and also able to inform future prospective studies on the program's safety for potential sample sizes needed for such assessments. As well, the study would also expose the potential for a higher than expected return to hospital for same day discharge patients which may not otherwise have been known.
A log of all patients initially enrolled as potentially "STAR Eligible" by their surgeon has been maintained by the PI. Using this list of patients, the following sequence of events will occur to assess each for hospital encounters for surgical related problems, inquiries or complications during the 30 days immediately following surgery:
- All patient's charts, both paper records at VGH and UBC Hospital, as well as electronic charts within the BC Care Connect network that can show encounters at hospitals throughout the province of British Columbia, will be retained by Research Personnel.
- Charts will be perused for any hospital encounters during the 30 days immediately post the date of surgery.
- If encounters are found, the specific nature of the encounter will be ascertained.
- Study personnel will decide, based on the clinical presentation and documentation available on the patient's chart, whether the encounter may be considered a "surgically related problem, inquiry or complication". Examples of surgically related problems include (but are not limited to) wound or surgical site infection, deep vein thrombosis, pneumonia, urinary tract infection, pain issues as a result of having surgery, failure or concerns for the function of the new prosthesis, trauma or falls as a result of reduced mobility following surgery.
- Some encounters may be obvious as surgically related problems - eg. concerns for a possible wound infection at the surgical site. Others may be less obviously surgically related depending on the presentation - eg. sepsis or organ failure. It will be left to the PI to invigilate and decide whether the reasons for hospital encounter are or are not obviously surgical in nature. For those deemed not obviously surgical, opinion will be sought from 2 independent specialists in Perioperative Internal Medicine on whether they feel the encounters to be related to the patient's hip arthroplasty. Reviewers will be blinded to each other's opinions. If both Reviewers agree that the encounter was for a surgically related problem then it will be tallied as such. If there is disagreement or both believe the problem to not be surgically related then it will not be considered a surgically related hospital encounter.
- If a hospital encounter is found amongst the patient's records, but no documentation about the nature of the encounter is available, then the Patient's Orthopedic Surgeon will be contacted to see if they retain any record of postoperative up to 30 day encounters and what the nature of the encounter was. Patients will NOT be contacted for the purpose of this QA study.
Approval for this study has been attained from the following:
- University of British Columbia Research Ethics Board.
- Vancouver Coastal Health Research Institute.
Study Personnel who will be retaining and invigilating patient charts will be the PI - a staff Anesthesiologist, a Resident in the UBC Anesthesiology Post-Graduate Program, and a UBC Medical Student.
It is anticipated that between 100 and 150 patients will have been through the STAR process at the time retrospective chart review begins.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eligible & Discharged Same Day | – | Other: Eligible for Same Day Discharge, Procedure: Primary Single Joint Total Hip Arthroplasty, Other: Discharge Same DaySurgeon earmarks patient as potentially eligible for Same Day Discharge. Preoperative Assessment by Physiotherapy and Anesthesia confirms patient is Same Day Discharge eligible. Patient undergoes Primary Single Joint Total Hip Arthroplasty and is discharged home on the day of surgery. |
| Eligible but NOT Discharged Same Day | – | Other: Eligible for Same Day Discharge, Procedure: Primary Single Joint Total Hip ArthroplastySurgeon earmarks patient as potentially eligible for Same Day Discharge. Preoperative Assessment by Physiotherapy and Anesthesia confirms patient is Same Day Discharge eligible. Patient undergoes Primary Single Joint Total Hip Arthroplasty but is NOT discharged home on the same day as the surgery, and remains in hospital for a minimum of one night following surgery. Reasons for not being discharged same day include potential problems related to Surgery (eg. complication), Anesthesia (eg. prolonged effect), or patient factors (egs. pain, nausea, mobility difficulties, etc.). |
| Not Eligible for Discharge Same Day | – | Procedure: Primary Single Joint Total Hip ArthroplastySurgeon earmarks patient as potentially eligible for Same Day Discharge. Preoperative Assessment by Physiotherapy and/or Anesthesia deems the patient to NOT be eligible for Same Day Discharge. The patient undergoes Primary Single Joint Total Hip Arthroplasty and remains for a minimum of one overnight in hospital following hip replacement surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hip joint pathology being booked for elective joint replacement by Orthopedics and earmarked by the surgeon as potentially Same Day Discharge eligible at the time of surgical booking.
Key inclusion criteria (1 listed)
- Surgical Team submits patient as potentially eligible for Same Day Discharge at the time of surgical booking.
Key exclusion criteria (1 listed)
- Excluded if the patient never has a surgical procedure despite surgical booking and preoperative assessment. All patients must undergo surgery to be included.
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 |
|---|---|---|
| Eligible for Same Day DischargePreoperative Physiotherapy and Anesthesia Criteria met. | Other | Eligible & Discharged Same Day, Eligible but NOT Discharged Same Day |
| Primary Single Joint Total Hip ArthroplastyTotal Hip Replacement Surgery | Procedure or surgery | Eligible & Discharged Same Day, Eligible but NOT Discharged Same Day, Not Eligible for Discharge Same Day |
| Discharge Same DayPostoperative criteria for Same Day Discharge met. | Other | Eligible & Discharged Same Day |
Primary outcome
The number of patients who return to hospital for assessment and/or treatment of a surgical related problem or complication following Primary Total Hip Arthroplasty.
Time frame: Within 30 days of elective Total Hip Arthroplasty surgery
Patient records will be reviewed for hospital encounters within 30 days of their surgical procedure. If encounters are found within this timeframe, it will be discerned whether the encounter is for a surgically related problem or complication. Examples of surgically related problems include (but are not limited to) wound or surgical site infection, deep vein thrombosis, pulmonary embolism, pneumonia, urinary tract infection, pain issues as a result of having surgery, failure or concerns for the function of the new prosthesis, trauma or falls as a result of reduced mobility following surgery.
1 secondary outcome
The number of Patients who return to hospital for assessment and/or treatment of surgical related problems or complications following Primary Total Hip Arthroplasty.
Time frame: Within 7 days of elective Total Hip Arthroplasty surgery
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 22 Apr 2020.
- Background: PubMed 30449455Meneghini R, Gibson W, Halsey D, Padgett D, Berend K, Della Valle CJ. The American Association of Hip and Knee Surgeons, Hip Society, Knee Society, and American Academy of Orthopaedic Surgeons Position Statement on Outpatient Joint Replacement. J Arthroplasty. 2018 Dec;33(12):3599-3601. doi: 10.1016/j.arth.2018.10.029. No abstract available.
- Background: PubMed 26336897Poitras S, Wood KS, Savard J, Dervin GF, Beaule PE. Predicting early clinical function after hip or knee arthroplasty. Bone Joint Res. 2015 Sep;4(9):145-51. doi: 10.1302/2046-3758.49.2000417.
- Background: PubMed 30738619Ziemba-Davis M, Caccavallo P, Meneghini RM. Outpatient Joint Arthroplasty-Patient Selection: Update on the Outpatient Arthroplasty Risk Assessment Score. J Arthroplasty. 2019 Jul;34(7S):S40-S43. doi: 10.1016/j.arth.2019.01.007. Epub 2019 Jan 15.
- Background: PubMed 28390881Meneghini RM, Ziemba-Davis M, Ishmael MK, Kuzma AL, Caccavallo P. Safe Selection of Outpatient Joint Arthroplasty Patients With Medical Risk Stratification: the "Outpatient Arthroplasty Risk Assessment Score". J Arthroplasty. 2017 Aug;32(8):2325-2331. doi: 10.1016/j.arth.2017.03.004. Epub 2017 Mar 14.
- Background: PubMed 28089186Sher A, Keswani A, Yao DH, Anderson M, Koenig K, Moucha CS. Predictors of Same-Day Discharge in Primary Total Joint Arthroplasty Patients and Risk Factors for Post-Discharge Complications. J Arthroplasty. 2017 Sep;32(9S):S150-S156.e1. doi: 10.1016/j.arth.2016.12.017. Epub 2016 Dec 22.
- Background: PubMed 27106923Kort NP, Bemelmans YFL, van der Kuy PHM, Jansen J, Schotanus MGM. Patient selection criteria for outpatient joint arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2668-2675. doi: 10.1007/s00167-016-4140-z. Epub 2016 Apr 22.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Donald J Young, MD principal investigator
University of British Columbia, Vancouver Coastal Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Arthroplasty Complications, run by University of British Columbia at 1 site in Canada.
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 22 Apr 2020. 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 Canada. 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?
The number of patients who return to hospital for assessment and/or treatment of a surgical related problem or complication following Primary Total Hip Arthroplasty. (time frame: Within 30 days of elective Total Hip Arthroplasty surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120324, which also lists 6 linked publications.
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 22 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.