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

Arthropathy of Knee Clinical Trial

Official title:

Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896282
• Other study ID #: HVH-SDK141-RCT
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: July 2020
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 1, 2020
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Hip
• Arthropathy of Knee
• Joint Diseases

Intervention

Other:
• Mobilization at a dedicated daycare facility
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.

Locations

Country	Name	City	State
Denmark	Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients discharged on day of surgery	Success rate of discharge on day of surgery	12 hours
Secondary	Patient reported outcomes	Total Oxford hip score (0-48, with 0 being worst and 48 best)	3 months
Secondary	Readmissions	Readmissions within 90 days	3 months
Secondary	Patient reported outcomes	Total Oxford knee score (0-48, with 0 being worst and 48 best)	3 months
Secondary	reoperations	reoperations within 90 days	3 months