Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward
Primary Purpose
Arthropathy of Knee, Arthropathy of Hip
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mobilization at a dedicated daycare facility
Sponsored by
About this trial
This is an interventional treatment trial for Arthropathy of Knee
Eligibility Criteria
Inclusion Criteria:
- Patients with clinical and radiological osteoarthritis of the hip suitable for primary cementless THA and patients with clinical and radiological osteoarthritis of the knee suitable for primary Cruciate Retaining (CR) TKA
- Age 18-80
- American Society of Anesthesiologists (ASA) Score (1-2)
- BMI <35
- Interested in and motivated for same day discharge
- Family or relatives to be present for >24 hours after discharge
- Able to understand and give consent to the study
Exclusion Criteria:
- Unable to provide care at own home on day of surgery for >24 hours after discharge
Sites / Locations
- Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
daycare facility
standard patient ward
Arm Description
After surgery patient stay at daycare facility for mobilisation and stay until discharge or transfer to standard patient ward if nor discharged by 20.000
After surgery patients are transferred to standard patient ward for mobilisation and stay until discharge.
Outcomes
Primary Outcome Measures
Patients discharged on day of surgery
Success rate of discharge on day of surgery
Secondary Outcome Measures
Patient reported outcomes
Total Oxford hip score (0-48, with 0 being worst and 48 best)
Readmissions
Readmissions within 90 days
Patient reported outcomes
Total Oxford knee score (0-48, with 0 being worst and 48 best)
reoperations
reoperations within 90 days
Full Information
NCT ID
NCT03896282
First Posted
March 27, 2019
Last Updated
July 29, 2020
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03896282
Brief Title
Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward
Official Title
Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this single center randomized controlled trial (RCT) is to investigate whether outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day discharge, without compromizing safety and outcome.
Detailed Description
Introduction of fast-track total hip arthroplasty (THA) and total knee arthroplasty (TKA) has led to a decrease in length of stay without compromising patient safety and clinical outcome . In recent years outpatient THA and TKA has gained popularity, especially as major focus is placed on reducing cost and increasing efficiency in all medical treatments . Studies have shown outpatient arthroplasty to be feasible both for THA and TKA patients , with up to 70% of unselected patients being potentially eligible for outpatient surgery. Various results are published on success rate of discharged patients on the day of surgery, ranging from 25% to 99% , depending on patient selection and logistic setup. While the majority of published studies utilizes a modern fast-track setup with early mobilization and multimodal pain treatment, the optimal logistic setup remains unknown.
The purpose of this single center randomized controlled trial (RCT) is to investigate whether outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day discharge, without compromizing safety and outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee, Arthropathy of Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
daycare facility
Arm Type
Active Comparator
Arm Description
After surgery patient stay at daycare facility for mobilisation and stay until discharge or transfer to standard patient ward if nor discharged by 20.000
Arm Title
standard patient ward
Arm Type
Active Comparator
Arm Description
After surgery patients are transferred to standard patient ward for mobilisation and stay until discharge.
Intervention Type
Other
Intervention Name(s)
Mobilization at a dedicated daycare facility
Intervention Description
All THA's are performed using a standard posterolateral approach with simple posterior soft-tissue repair. No infiltration anesthesia (LIA) is used in THA's. All TKA's are performed with a standard medial parapatellar approach without the use of tourniquet. Physiotherapy is started as soon as possible after surgery in the dedicated day care facility. Time till first mobilization is recorded as is total time mobilized supervised by a physiotherapist before discharge.
Patients are discharged if fulfilling the discharge criteria before 8 pm. Number of hours spent in hospital in total is recorded.
Primary Outcome Measure Information:
Title
Patients discharged on day of surgery
Description
Success rate of discharge on day of surgery
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Patient reported outcomes
Description
Total Oxford hip score (0-48, with 0 being worst and 48 best)
Time Frame
3 months
Title
Readmissions
Description
Readmissions within 90 days
Time Frame
3 months
Title
Patient reported outcomes
Description
Total Oxford knee score (0-48, with 0 being worst and 48 best)
Time Frame
3 months
Title
reoperations
Description
reoperations within 90 days
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with clinical and radiological osteoarthritis of the hip suitable for primary cementless THA and patients with clinical and radiological osteoarthritis of the knee suitable for primary Cruciate Retaining (CR) TKA
Age 18-80
American Society of Anesthesiologists (ASA) Score (1-2)
BMI <35
Interested in and motivated for same day discharge
Family or relatives to be present for >24 hours after discharge
Able to understand and give consent to the study
Exclusion Criteria:
Unable to provide care at own home on day of surgery for >24 hours after discharge
Facility Information:
Facility Name
Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward
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