search
Back to results

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
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 27, 2019
Last Updated
July 29, 2020
Sponsor
Hvidovre University Hospital
search

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

Learn more about this trial

Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward

We'll reach out to this number within 24 hrs