Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03896282 |
Recruitment Status :
Completed
First Posted : March 29, 2019
Last Update Posted : July 30, 2020
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | March 27, 2019 | ||||
First Posted Date ICMJE | March 29, 2019 | ||||
Last Update Posted Date | July 30, 2020 | ||||
Actual Study Start Date ICMJE | August 1, 2017 | ||||
Actual Primary Completion Date | November 1, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Patients discharged on day of surgery [ Time Frame: 12 hours ] Success rate of discharge on day of surgery
|
||||
Original Primary Outcome Measures ICMJE |
Patients discharged on day of surgery [ Time Frame: 12 hours ] Succes rate of discharge on day of surgery
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward | ||||
Official Title ICMJE | 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 ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | 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 ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
50 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | February 1, 2020 | ||||
Actual Primary Completion Date | November 1, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Denmark | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03896282 | ||||
Other Study ID Numbers ICMJE | HVH-SDK141-RCT | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Kirill Gromov, Hvidovre University Hospital | ||||
Study Sponsor ICMJE | Hvidovre University Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Hvidovre University Hospital | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |