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Completed

NCT Number: NCT03896282

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patients discharged on day of surgery

    Time frame: 12 hours

    Success rate of discharge on day of surgery

Secondary outcomes

  1. Patient reported outcomes

    Time frame: 3 months

    Total Oxford hip score (0-48, with 0 being worst and 48 best)

  2. Readmissions

    Time frame: 3 months

    Readmissions within 90 days

  3. Patient reported outcomes

    Time frame: 3 months

    Total Oxford knee score (0-48, with 0 being worst and 48 best)

  4. reoperations

    Time frame: 3 months

    reoperations within 90 days

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Mar 29, 2019
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.