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

NCT03896282 | Completed DMC

• 1 other identifier: HVH-SDK141-RCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee; Arthropathy of Hip

Outcome Measures

Primary Outcomes (1)

• Patients discharged on day of surgery

  Success rate of discharge on day of surgery

  12 hours

Secondary Outcomes (4)

• Patient reported outcomes

  3 months

• Readmissions

  3 months

• Patient reported outcomes

  3 months

• reoperations

  3 months

Study Arms (2)

daycare facility

ACTIVE COMPARATOR

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

Other: Mobilization at a dedicated daycare facility

standard patient ward

ACTIVE COMPARATOR

After surgery patients are transferred to standard patient ward for mobilisation and stay until discharge.

Other: Mobilization at a dedicated daycare facility

Interventions

Mobilization at a dedicated daycare facility OTHER

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.

daycare facility; standard patient ward

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide care at own home on day of surgery for \>24 hours after discharge

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Ass. professor

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: August 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: February 1, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

DK (1)