OsteoarthritisNCT02544620
Out Patient Surgery for Total Knee and Hip Replacement and Unicompartmental Knee Replacement - a Feasibility Study
An observational study of Osteoarthritis, run by Kirill Gromov at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate feasibly of outpatient Total Knee Replacement, Total Hip Replacement and Unicompartmental Knee Replacement in a modern fast-track setup. The design is as an observational prospective study, evaluating patients that fulfil discharge criteria on the day of the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Does fulfil of discharge criteria on the day of the surgery and Does not fulfil of discharge criteria on the day of the surgery
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to 31 Dec 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Unselected primary THA/TKA/UKA * ASA score I/II * Can be operated as #1 or #2 * No sleep apnea treated with CPAP
Who may be able to join
- Unselected primary THA/TKA
- ASA score I/II
- Can be operated as #1 or #2
- No sleep apnea treated with CPAP
Who cannot join
- Selected primary THA/TKA
- ASA score > 2
- Cannot be operated as #1 or #2
- Sleep apnea treated with CPAP
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate feasibly of outpatient Total Knee Replacement, Total Hip Replacement and Unicompartmental Knee Replacement in a modern fast-track setup. The design is as an observational prospective study, evaluating patients that fulfil discharge criteria on the day of the surgery. The investigators will further evaluate safety aspects, such a early morbidity and mortality, as well as patient satisfaction.
Read the detailed description
Fast-track total hip arthroplasty (THA), total knee arthroplasty (TKA) and Unicompartmental Knee arthroplasty (UKA) with length of stay (LOS) of 1-3 is a well established concept for treating hip and knee osteoarthritis, resulting in short reconvalescence, high patient satisfaction, and an excellent safety profile (lower or similar mortality / morbidity compared to conventional pathways with longer LOS). LOS have been significantly reduced during the past decade, and several centers have published even shorter hospitals stays: <24 hours, with patients staying the night at the hospital but also outpatient surgery, with patients being discharged on the day of surgery.
However, these proposed pathways with extremely short LOS, are performed on very selected patients, with few details on patient satisfaction, outcome and most important patient safety. Therefore, it is not possible to draw conclusions on feasibility of outpatient THA, TKA and UKA surgery in a general and unselected population. Further on, there is a need for investigation of safety aspects of outpatient surgery in respect to mortality, morbidity, patient satisfaction and patient reported outcomes. As some, most likely healthy and younger, patients might benefit from outpatient surgery - eg discharge on the day of surgery, while others might not; the first step is to identify the patients that are suitable for outpatient THA and TKA surgery and investigate the safety aspects in respect to mortality, morbidity, patient satisfaction and patient reported outcomes.
Aim:
The aim of this study is to investigate "feasibility" and "safety" of outpatient THA, TKA and UKA surgery, respectively as follows:
Feasibility
- Proportion of patients, that can be included in the study according to inclusion criteria stated below, and be evaluated for potential same-day discharge (I) (I = included)
- Proportion of included patients (I), that are discharged on the day of surgery (U) and those who are not discharged and stay for >1 day (B)
- Identify reasons for patients not being able to be discharged on the day of surgery (B)
Safety
- risk for complications (morbidity) in group (U) compared to group (B) (are there complications that potentially could have been avoided is the patient was not discharged)
- readmissions in group (U ) compared to group (B) within 90 days
- mortality in group (U ) compared to group (B) within 90 days
- patient satisfaction in group (U ) compared to group (B)
- Patient reported outcome (Oxford knee score + range of motion for TKA and UKA group, and Oxford hip score for THA group) in group (U) compared to group (B)
- contacts to primary sector in group (U ) compared to group (B) within 7 days.
- use of rescue morphine (pain journal) for 7 days post op in group (U ) compared to group (B)
- Conditions
- Osteoarthritis
- Being tested
- Does fulfil of discharge criteria on the day of the surgery, Does not fulfil of discharge criteria on the day of the surgery
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Does fulfil of discharge criteria on the day of the surgeryOther
Does not fulfil of discharge criteria on the day of the surgeryOther
| Study group | Role | What they receive |
|---|---|---|
| Total Hip arthroplasty | * Unselected primary THA
* American Society of Anesthesiologists (ASA) score I/II
* Can be operated as #1 or #2
* No sleep apnea treated with Continuous positive airway pressure (CPAP) Receives: Other: Does fulfil of discharge criteria on the day of the surgery; Other: Does not fulfil of discharge criteria on the day of the surgery | |
| Total Knee arthroplasty | * Unselected primary TKA
* American Society of Anesthesiologists (ASA) score I/II
* Can be operated as #1 or #2
* No sleep apnea treated with Continuous positive airway pressure (CPAP) Receives: Other: Does fulfil of discharge criteria on the day of the surgery; Other: Does not fulfil of discharge criteria on the day of the surgery | |
| unicompartmental knee arthroplasty | * Unselected primary UKA
* American Society of Anesthesiologists (ASA) score I/II
* Can be operated as #1 or #2
* No sleep apnea treated with Continuous positive airway pressure (CPAP) Receives: Other: Does fulfil of discharge criteria on the day of the surgery; Other: Does not fulfil of discharge criteria on the day of the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fulfilment of same day discharge criteria
On the days of surgery following discharge criteria are continuously evaluated:
- < 500 ml intraoperative blood loss
- Back in patient ward <15.00
- Received instruction from physiotherapist and is safely mobilized
- No clinical symptoms of anemia
- Pain <3 while resting, <5 during exercise.
- Spontaneous urination
- Post op x-ray is performed and approved
- Relatives or friends with patient for >24 hours
- Motivated and accepts same day discharge
- Standard discharge criteria fulfilled
- Can be discharged before 20.00
If all of the above criteria are fulfilled, the patient can be discharged
Measured: 12 hours
Secondary outcomes (3)
Readmissions
Measured: 3 months
Patient reported satisfaction
OKS (Oxford Knee score) and ROM (Range og motion) for TKA and UKA, OHS for THA
Measured: 3 months
Use of rescue morphine
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion31 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirill Gromov
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Vejle Hospital, Holsterbro Sygehus, DK
- Responsible party
- Sponsor-investigator, Kirill Gromov, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544620
- Sponsor's protocol ID
- HVH-SK-TKA-THA-UKA
- Status last verified
- Mar 2019
- First submitted
- 6 Sep 2015
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out Patient Surgery for Total Knee and Hip Replacement and Unicompartmental Knee Replacement - a Feasibility Study
- ClinicalTrials.gov ID
- NCT02544620
- Acronym / sponsor ID
- HVH-SK-TKA-THA-UKA
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Kirill GromovUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Vejle Hospital, Holsterbro Sygehus, DK
- Study start
- Sep 2015
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Sep 2015 (estimated)
- 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 study is to evaluate feasibly of outpatient Total Knee Replacement, Total Hip Replacement and Unicompartmental Knee Replacement in a modern fast-track setup. The design is as an observational prospective study, evaluating patients that fulfil discharge criteria on the day of the surgery. The investigators will further evaluate safety aspects, such a early morbidity and mortality, as well as patient satisfaction.
Detailed description
Fast-track total hip arthroplasty (THA), total knee arthroplasty (TKA) and Unicompartmental Knee arthroplasty (UKA) with length of stay (LOS) of 1-3 is a well established concept for treating hip and knee osteoarthritis, resulting in short reconvalescence, high patient satisfaction, and an excellent safety profile (lower or similar mortality / morbidity compared to conventional pathways with longer LOS). LOS have been significantly reduced during the past decade, and several centers have published even shorter hospitals stays: <24 hours, with patients staying the night at the hospital but also outpatient surgery, with patients being discharged on the day of surgery.
However, these proposed pathways with extremely short LOS, are performed on very selected patients, with few details on patient satisfaction, outcome and most important patient safety. Therefore, it is not possible to draw conclusions on feasibility of outpatient THA, TKA and UKA surgery in a general and unselected population. Further on, there is a need for investigation of safety aspects of outpatient surgery in respect to mortality, morbidity, patient satisfaction and patient reported outcomes. As some, most likely healthy and younger, patients might benefit from outpatient surgery - eg discharge on the day of surgery, while others might not; the first step is to identify the patients that are suitable for outpatient THA and TKA surgery and investigate the safety aspects in respect to mortality, morbidity, patient satisfaction and patient reported outcomes.
Aim:
The aim of this study is to investigate "feasibility" and "safety" of outpatient THA, TKA and UKA surgery, respectively as follows:
Feasibility
- Proportion of patients, that can be included in the study according to inclusion criteria stated below, and be evaluated for potential same-day discharge (I) (I = included)
- Proportion of included patients (I), that are discharged on the day of surgery (U) and those who are not discharged and stay for >1 day (B)
- Identify reasons for patients not being able to be discharged on the day of surgery (B)
Safety
- risk for complications (morbidity) in group (U) compared to group (B) (are there complications that potentially could have been avoided is the patient was not discharged)
- readmissions in group (U ) compared to group (B) within 90 days
- mortality in group (U ) compared to group (B) within 90 days
- patient satisfaction in group (U ) compared to group (B)
- Patient reported outcome (Oxford knee score + range of motion for TKA and UKA group, and Oxford hip score for THA group) in group (U) compared to group (B)
- contacts to primary sector in group (U ) compared to group (B) within 7 days.
- use of rescue morphine (pain journal) for 7 days post op in group (U ) compared to group (B)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total Hip arthroplasty | – | Other: Does fulfil of discharge criteria on the day of the surgery, Other: Does not fulfil of discharge criteria on the day of the surgery* Unselected primary THA * American Society of Anesthesiologists (ASA) score I/II * Can be operated as #1 or #2 * No sleep apnea treated with Continuous positive airway pressure (CPAP) |
| Total Knee arthroplasty | – | Other: Does fulfil of discharge criteria on the day of the surgery, Other: Does not fulfil of discharge criteria on the day of the surgery* Unselected primary TKA * American Society of Anesthesiologists (ASA) score I/II * Can be operated as #1 or #2 * No sleep apnea treated with Continuous positive airway pressure (CPAP) |
| unicompartmental knee arthroplasty | – | Other: Does fulfil of discharge criteria on the day of the surgery, Other: Does not fulfil of discharge criteria on the day of the surgery* Unselected primary UKA * American Society of Anesthesiologists (ASA) score I/II * Can be operated as #1 or #2 * No sleep apnea treated with Continuous positive airway pressure (CPAP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Unselected primary THA/TKA/UKA * ASA score I/II * Can be operated as #1 or #2 * No sleep apnea treated with CPAP
Key inclusion criteria (4 listed)
- Unselected primary THA/TKA
- ASA score I/II
- Can be operated as #1 or #2
- No sleep apnea treated with CPAP
Key exclusion criteria (4 listed)
- Selected primary THA/TKA
- ASA score > 2
- Cannot be operated as #1 or #2
- Sleep apnea treated with CPAP
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 |
|---|---|---|
| Does fulfil of discharge criteria on the day of the surgery | Other | Total Hip arthroplasty, Total Knee arthroplasty, unicompartmental knee arthroplasty |
| Does not fulfil of discharge criteria on the day of the surgery | Other | Total Hip arthroplasty, Total Knee arthroplasty, unicompartmental knee arthroplasty |
Primary outcome
Fulfilment of same day discharge criteria
Time frame: 12 hours
On the days of surgery following discharge criteria are continuously evaluated: * < 500 ml intraoperative blood loss * Back in patient ward <15.00 * Received instruction from physiotherapist and is safely mobilized * No clinical symptoms of anemia * Pain <3 while resting, <5 during exercise. * Spontaneous urination * Post op x-ray is performed and approved * Relatives or friends with patient for >24 hours * Motivated and accepts same day discharge * Standard discharge criteria fulfilled * Can be discharged before 20.00 If all of the above criteria are fulfilled, the patient can be discharged
3 secondary outcomes
Readmissions
Time frame: 3 months
Patient reported satisfaction
Time frame: 3 months
Use of rescue morphine
Time frame: 7 days
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 28 Mar 2019.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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?
An observational study of Osteoarthritis, run by Kirill Gromov 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 4 inclusion and 4 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 28 Mar 2019. 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?
Fulfilment of same day discharge criteria (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 28 Mar 2019.