Osteoarthritis, Hip Clinical Trial
Official title:
Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
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.
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:
1. The patient was deemed STAR eligible preoperatively, had their hip replacement surgery
and went home the same day as their surgery [presently 24 patients].
2. 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].
3. 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:
1. 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.
2. Charts will be perused for any hospital encounters during the 30 days immediately post
the date of surgery.
3. If encounters are found, the specific nature of the encounter will be ascertained.
4. 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.
5. 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.
6. 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:
1. University of British Columbia Research Ethics Board.
2. 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05773261 -
Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
|
N/A | |
Recruiting |
NCT05223777 -
KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA)
|
N/A | |
Recruiting |
NCT04731077 -
Avenir Complete Post-Market Clinical Follow-Up Study
|
N/A | |
Not yet recruiting |
NCT04448106 -
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
|
Phase 2 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT06162195 -
The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
|
N/A | |
Withdrawn |
NCT02743208 -
Evaluation of a Short Femoral Stem in Total Hip Arthroplasty
|
N/A | |
Completed |
NCT02944448 -
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
|
Phase 2 | |
Active, not recruiting |
NCT02229279 -
Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures
|
N/A | |
Active, not recruiting |
NCT02851992 -
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem
|
N/A | |
Completed |
NCT01618708 -
A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip
|
N/A | |
Completed |
NCT01700933 -
Dose-response: Exercise Therapy on Hip Osteoarthritis
|
N/A | |
Completed |
NCT01214954 -
Early Rehabilitation After Total Hip Replacement
|
N/A | |
Active, not recruiting |
NCT00294424 -
Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements
|
N/A | |
Terminated |
NCT00588861 -
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
|
N/A | |
Withdrawn |
NCT05054595 -
Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention
|
N/A | |
Terminated |
NCT00973141 -
A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain
|
Phase 2 | |
Recruiting |
NCT05014113 -
H-28 DELTA ST-C and Minima Retrospective Study.
|
||
Completed |
NCT01066936 -
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
|
||
Recruiting |
NCT05530551 -
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
|
N/A |