Arthropathy of KneeNCT03896282
Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward
A study testing Mobilization at a dedicated daycare facility in people with Arthropathy of Knee and Arthropathy of Hip, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthropathy of Knee, Arthropathy of Hip
- What is being tested?
- Mobilization at a dedicated daycare facility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide care at own home on day of surgery for >24 hours after discharge
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Hvidovre, 2650
About this study
Official title: Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward - a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Arthropathy of Knee, Arthropathy of Hip
- Being tested
- Mobilization at a dedicated daycare facility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization at a dedicated daycare facilityOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Mobilization at a dedicated daycare facility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients discharged on day of surgery
Success rate of discharge on day of surgery
Measured: 12 hours
Secondary outcomes (4)
Patient reported outcomes
Total Oxford hip score (0-48, with 0 being worst and 48 best)
Measured: 3 months
Readmissions
Readmissions within 90 days
Measured: 3 months
Patient reported outcomes
Total Oxford knee score (0-48, with 0 being worst and 48 best)
Measured: 3 months
reoperations
reoperations within 90 days
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Aug 2017
- Primary completion1 Nov 2018
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirill Gromov, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896282
- Sponsor's protocol ID
- HVH-SDK141-RCT
- Status last verified
- Jul 2020
- First submitted
- 27 Mar 2019
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03896282
- Acronym / sponsor ID
- HVH-SDK141-RCT
- Conditions
- Arthropathy of Knee, Arthropathy of Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| daycare facility | Active comparator | Other: Mobilization at a dedicated daycare facilityAfter surgery patient stay at daycare facility for mobilisation and stay until discharge or transfer to standard patient ward if nor discharged by 20.000 |
| standard patient ward | Active comparator | Other: Mobilization at a dedicated daycare facilityAfter surgery patients are transferred to standard patient ward for mobilisation and stay until discharge. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to provide care at own home on day of surgery for >24 hours after discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilization at a dedicated daycare facilityAll 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. | Other | daycare facility, standard patient ward |
Primary outcome
Patients discharged on day of surgery
Time frame: 12 hours
Success rate of discharge on day of surgery
4 secondary outcomes
Patient reported outcomes
Time frame: 3 months
Readmissions
Time frame: 3 months
Patient reported outcomes
Time frame: 3 months
reoperations
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization at a dedicated daycare facility in people with Arthropathy of Knee and Arthropathy of Hip, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients discharged on day of surgery (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.