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Trial record 2 of 3486 for:    Facility

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

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ClinicalTrials.gov Identifier: NCT03896282
Recruitment Status : Active, not recruiting
First Posted : March 29, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Kirill Gromov, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Arthropathy of Knee Arthropathy of Hip Other: Mobilization at a dedicated daycare facility Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward - a Randomized Controlled Trial
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : November 1, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Active Comparator: daycare facility
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

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.


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





Primary Outcome Measures :
  1. Patients discharged on day of surgery [ Time Frame: 12 hours ]
    Success rate of discharge on day of surgery


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896282


Locations
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Denmark
Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital

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Responsible Party: Kirill Gromov, MD, PhD, Ass. professor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03896282     History of Changes
Other Study ID Numbers: HVH-SDK141-RCT
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases