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

• ClinicalTrials.gov Identifier: NCT03896282
• Recruitment Status: Completed
• First Posted: March 29, 2019
• Last Update Posted: July 30, 2020
• Sponsor: Hvidovre University Hospital
• Information provided by (Responsible Party): Kirill Gromov, Hvidovre University Hospital

Tracking Information

• First Submitted Date: March 27, 2019
• First Posted Date: March 29, 2019
• Last Update Posted Date: July 30, 2020
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: November 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2019)

Patients discharged on day of surgery [ Time Frame: 12 hours ]

Success rate of discharge on day of surgery

Original Primary Outcome Measures (submitted: March 28, 2019)

Patients discharged on day of surgery [ Time Frame: 12 hours ]

Succes rate of discharge on day of surgery

Current Secondary Outcome Measures (submitted: March 29, 2019)

• Patient reported outcomes [ Time Frame: 3 months ]
  Total Oxford hip score (0-48, with 0 being worst and 48 best)
• Readmissions [ Time Frame: 3 months ]
  Readmissions within 90 days
• Patient reported outcomes [ Time Frame: 3 months ]
  Total Oxford knee score (0-48, with 0 being worst and 48 best)
• reoperations [ Time Frame: 3 months ]
  reoperations within 90 days

Original Secondary Outcome Measures (submitted: March 28, 2019)

• Patient reported outcomes [ Time Frame: 3 months ]
  Oxford hip score
• Readmissions [ Time Frame: 3 months ]
  Readmissions within 90 days
• Patient reported outcomes [ Time Frame: 3 months ]
  Oxford knee score
• reoperations [ Time Frame: 3 months ]
  reoperations within 90 days

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Arthropathy of Knee
• Arthropathy of Hip

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.

Study Arms

• 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
  Intervention: Other: Mobilization at a dedicated daycare facility
• Active Comparator: standard patient ward
  After surgery patients are transferred to standard patient ward for mobilisation and stay until discharge.
  Intervention: Other: Mobilization at a dedicated daycare facility

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 28, 2019): 50
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 1, 2020
• Actual Primary Completion Date: November 1, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT03896282
• Other Study ID Numbers: HVH-SDK141-RCT
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Kirill Gromov, Hvidovre University Hospital
• Study Sponsor: Hvidovre University Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hvidovre University Hospital
• Verification Date: July 2020