Same-day SurgeryNCT04790591
Is Partial Knee Replacement as Same-day Surgery Generalizable?
A study testing Same-day surgery in people with Same-day Surgery, run by Region Skane at 2 sites in Sweden.
Trial summary
Fast-track/rapid recovery/Enhanced Recovery After Surgery (ERAS) programs have proven both safe and effective in joint replacement surgery, to the degree where same-day surgery have been tested in selected cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Same-day Surgery
- What is being tested?
- Same-day surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSweden
- Study dates
- 7 Feb 2019to 18 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All participants/patients that will undergo a partial knee replacement (PKR) procedure within one consecutive year by one high-volume surgeon (i.e. no preselection of patients will be made)
Who cannot join
- PKR procedures performed by other surgeons
- One-stage bilateral PKR procedures
- PKR procedures not given the first surgery slot of the day
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Skåne University Hospital
Lund, Region Skåne, 221 85
Trelleborg Hospital
Trelleborg, Region Skåne, 231 85
About this study
Official title: Is Partial Knee Replacement as Same-day Surgery Generalizable? A Non-selective Interventional Study on Efficacy, Patient Satisfaction, and Safety in a Public Hospital Setting
Fast-track/rapid recovery/Enhanced Recovery After Surgery (ERAS) programs have proven both safe and effective in joint replacement surgery, to the degree where same-day surgery have been tested in selected cases. A transition of the minor partial knee replacement (PKR) procedure, compared with the alternative and more commonly used total knee replacement (TKR) for knee osteoarthritis, into a same-day regime seems reasonable. Especially as PKR is reported to have lower risk of short-term complications than does TKR.
The aim of this study is to assess efficacy, patient satisfaction and safety outcome measures for PKR when using a same-day surgery protocol in a Swedish healthcare context where ERAS programs nowadays are considered common ground.
Read more
With no preselection of patients, all PKR cases by one high-volume surgeon will chronologically be scheduled as the first morning case for one consecutive year, and thereby be included in the study. In order for discharge, strict post-surgery criteria will have to be met.
The thesis is that the same-day surgery will be both feasible and safe.
Read the detailed description
The eligibility for being considered a medial PKR is either antero-medial osteoarthritis or spontaneous osteonecrosis of the knee. The study-protocol has a pragmatic approach to whom of the PKR candidates will be considered for same-day surgery, as no preselection of patients will be done prior to surgery. I.e., everyone considered for a PKR procedure will be informed prior to surgery by a multidisciplinary team (anesthesiologist, nurse, physiotherapist, and surgeon) that if the surgery will be scheduled in the morning, he/she will then be following a same-day surgery protocol and likely be discharged to home later the same day.
All of one high-volume surgeon´s (MT) first morning slots for one consecutive year will be dedicated to patients who will undergo PKR surgery, and thereby also be included in the study. The slots will be filled continuously as the patients are put up for surgery. When all slots have been taken within one week any additional PKR cases will be assigned to surgery later in the day the same week (as will all the THRs and the TKRs during this period) and consequently not taking part in this study. The operation scheduling will be put together on a weekly basis, in a strict chronological order, by a team of nurses without any insight from the surgeon in question.
The criteria for discharge will be based strictly on postoperative parameters categorized into four dimensions - vital parameters, urinary function, bleeding, and mobilization. The vital parameters will be measured and scored by the National Early Warning Score (NEWS), where the threshold for discharge will be conservatively set to zero (NEWS 0). The urinary function algorithm for discharge will, in short, be if no need for catheterization and less than 200 ml of residual volume after spontaneous void. A compression stocking will be removed six hours post-surgery and if no ongoing bleeding discharge can be considered. Last, but not least, a physiotherapist will evaluate whether basic activity of daily living (ADL) can be performed in a safely manner using crutches.
Primary outcome measures for this three-month follow-up will be safety, i.e. number of adverse events and readmissions. Secondary aims will be feasibility such as same-day surgery achievement and extra outpatient visits needed and for what reasons. Patient-satisfaction will also be evaluated after the participants/patients have ben discharged to their own home. A two-arm subgroup analysis will be conducted between those aged <80 yrs and classified as ASA <3 and those aged ≥80 yrs. and/or classified as ASA class ≥3.
Descriptive data will be presented as unadjusted means with standard deviations (SD), medians with range, or as numbers with proportions (%). The between-group differences will be presented as means with 95% confidence intervals (95% CI) and p values using Welch's test, Mann-Whitney U-test and Likelihood Ratio Test (or when violated Fisher's exact test) for numerical, ordinal and categorical variables respectively. Multivariate analyses will be conducted using logistic regression.
- Conditions
- Same-day Surgery
- Being tested
- Same-day surgery
- Keywords
- Arthroplasty, PKR, Same-day discharge, Same-day surgery, UKA
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-day surgeryProcedure or surgery
To be allowed same-day discharge certain postoperative criteria have to be met. These are categorized into four dimensions - vital parameters, urinary function, bleeding, and mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Age <80 yrs. and ASA class <3 | Active comparator | To follow a same-day surgery protocol when undergoing a partial knee replacement procedure. Receives: Procedure: Same-day surgery |
| Age ≥80 yrs. and/or ASA class ≥3 | Active comparator | To follow a same-day surgery protocol when undergoing a partial knee replacement procedure. Receives: Procedure: Same-day surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - adverse events and/or readmissions
Number of severe complications that may have had a causal association with the same-day surgery and any readmissions, no matter the cause
Measured: 3 months
Secondary outcomes (2)
Feasibility - same-day surgery discharge and resources relocated from the inpatient to the outpatient department
Number of participants that will achieve discharge on the day of surgery and number of additional outpatient visits required compared to planned
Measured: 12 hours and 3 months respectively
Patient-satisfaction
Number of participants that will agree on all three of the following statements when phoned the day after surgery: "A positive experience; would do it again; can recommend to others"
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start7 Feb 2019
- Primary completion14 Feb 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Same-day SurgeryStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Open clinical trial with a subgroup analysis (One can argue whether this study should be defined as a cohort study or as an open clinical trial. The idea of the study originated from the need to observe/confirm the feasibility and safety aspects of a routine which as of today has become common practice, namely same-day surgery, but as such it may also be categorized as a treatment... Either way, based on the preselection of age and comorbidity often reported in the literature, a two-arm subgroup analysis of the nonselective study participants will be conducted.)
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Tveit, Region Skane
- Investigators
- Magnus Tveit, MD, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790591
- Sponsor's protocol ID
- 2020-02000
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Partial Knee Replacement as Same-day Surgery Generalizable? A Non-selective Interventional Study on Efficacy, Patient Satisfaction, and Safety in a Public Hospital Setting
- ClinicalTrials.gov ID
- NCT04790591
- Acronym / sponsor ID
- 2020-02000
- Conditions
- Same-day Surgery
- Keywords
- Arthroplasty, PKR, Same-day discharge, Same-day surgery, UKA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 10 Mar 2021 (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.
Fast-track/rapid recovery/Enhanced Recovery After Surgery (ERAS) programs have proven both safe and effective in joint replacement surgery, to the degree where same-day surgery have been tested in selected cases. A transition of the minor partial knee replacement (PKR) procedure, compared with the alternative and more commonly used total knee replacement (TKR) for knee osteoarthritis, into a same-day regime seems reasonable. Especially as PKR is reported to have lower risk of short-term complications than does TKR.
The aim of this study is to assess efficacy, patient satisfaction and safety outcome measures for PKR when using a same-day surgery protocol in a Swedish healthcare context where ERAS programs nowadays are considered common ground.
With no preselection of patients, all PKR cases by one high-volume surgeon will chronologically be scheduled as the first morning case for one consecutive year, and thereby be included in the study. In order for discharge, strict post-surgery criteria will have to be met.
The thesis is that the same-day surgery will be both feasible and safe.
Detailed description
The eligibility for being considered a medial PKR is either antero-medial osteoarthritis or spontaneous osteonecrosis of the knee. The study-protocol has a pragmatic approach to whom of the PKR candidates will be considered for same-day surgery, as no preselection of patients will be done prior to surgery. I.e., everyone considered for a PKR procedure will be informed prior to surgery by a multidisciplinary team (anesthesiologist, nurse, physiotherapist, and surgeon) that if the surgery will be scheduled in the morning, he/she will then be following a same-day surgery protocol and likely be discharged to home later the same day.
All of one high-volume surgeon´s (MT) first morning slots for one consecutive year will be dedicated to patients who will undergo PKR surgery, and thereby also be included in the study. The slots will be filled continuously as the patients are put up for surgery. When all slots have been taken within one week any additional PKR cases will be assigned to surgery later in the day the same week (as will all the THRs and the TKRs during this period) and consequently not taking part in this study. The operation scheduling will be put together on a weekly basis, in a strict chronological order, by a team of nurses without any insight from the surgeon in question.
The criteria for discharge will be based strictly on postoperative parameters categorized into four dimensions - vital parameters, urinary function, bleeding, and mobilization. The vital parameters will be measured and scored by the National Early Warning Score (NEWS), where the threshold for discharge will be conservatively set to zero (NEWS 0). The urinary function algorithm for discharge will, in short, be if no need for catheterization and less than 200 ml of residual volume after spontaneous void. A compression stocking will be removed six hours post-surgery and if no ongoing bleeding discharge can be considered. Last, but not least, a physiotherapist will evaluate whether basic activity of daily living (ADL) can be performed in a safely manner using crutches.
Primary outcome measures for this three-month follow-up will be safety, i.e. number of adverse events and readmissions. Secondary aims will be feasibility such as same-day surgery achievement and extra outpatient visits needed and for what reasons. Patient-satisfaction will also be evaluated after the participants/patients have ben discharged to their own home. A two-arm subgroup analysis will be conducted between those aged <80 yrs and classified as ASA <3 and those aged ≥80 yrs. and/or classified as ASA class ≥3.
Descriptive data will be presented as unadjusted means with standard deviations (SD), medians with range, or as numbers with proportions (%). The between-group differences will be presented as means with 95% confidence intervals (95% CI) and p values using Welch's test, Mann-Whitney U-test and Likelihood Ratio Test (or when violated Fisher's exact test) for numerical, ordinal and categorical variables respectively. Multivariate analyses will be conducted using logistic regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open clinical trial with a subgroup analysis (One can argue whether this study should be defined as a cohort study or as an open clinical trial. The idea of the study originated from the need to observe/confirm the feasibility and safety aspects of a routine which as of today has become common practice, namely same-day surgery, but as such it may also be categorized as a treatment... Either way, based on the preselection of age and comorbidity often reported in the literature, a two-arm subgroup analysis of the nonselective study participants will be conducted.)
| Arm | Type | Receives |
|---|---|---|
| Age <80 yrs. and ASA class <3 | Active comparator | Procedure: Same-day surgeryTo follow a same-day surgery protocol when undergoing a partial knee replacement procedure. |
| Age ≥80 yrs. and/or ASA class ≥3 | Active comparator | Procedure: Same-day surgeryTo follow a same-day surgery protocol when undergoing a partial knee replacement procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All participants/patients that will undergo a partial knee replacement (PKR) procedure within one consecutive year by one high-volume surgeon (i.e. no preselection of patients will be made)
Key exclusion criteria (3 listed)
- PKR procedures performed by other surgeons
- One-stage bilateral PKR procedures
- PKR procedures not given the first surgery slot of the day
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 |
|---|---|---|
| Same-day surgeryTo be allowed same-day discharge certain postoperative criteria have to be met. These are categorized into four dimensions - vital parameters, urinary function, bleeding, and mobilization. | Procedure or surgery | Age <80 yrs. and ASA class <3, Age ≥80 yrs. and/or ASA class ≥3 |
Primary outcome
Safety - adverse events and/or readmissions
Time frame: 3 months
Number of severe complications that may have had a causal association with the same-day surgery and any readmissions, no matter the cause
2 secondary outcomes
Feasibility - same-day surgery discharge and resources relocated from the inpatient to the outpatient department
Time frame: 12 hours and 3 months respectively
Patient-satisfaction
Time frame: 24 hours
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 12 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Magnus Tveit, MD, PhD principal investigator
Region Skane
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same-day surgery in people with Same-day Surgery, run by Region Skane at 2 sites in Sweden.
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 1 inclusion and 3 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Safety - adverse events and/or readmissions (time frame: 3 months). 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 12 Mar 2021.