Arthroplasty, Replacement, KneeNCT03411083
Silkeborg Knee Replacement Cohort Study
An observational study of Arthroplasty, Replacement, Knee, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
In this cohort study, we will investigate short and long term outcomes after knee replacement surgery and identify preoperative and early postoperative factors associated with long term outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Total or unicompartmental knee replacement
- Type of treatment
- Surgery or procedure
- How many people
- 1,225 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 23 Mar 2021
- 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: Patients assigned for primary knee replacement in the period from February 2018 to May 2020 will be consecutively recruited to the cohort from Silkeborg Regional Hospital Denmark.
Who may be able to join
- Assigned for primary Unicompartmental or Total Knee Replacement
- Age ≥ 18 years at the time of recruitment
- Able to read and understand Danish
Who cannot join
- Not mentally able to reply to the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
In this cohort study, we will investigate short and long term outcomes after knee replacement surgery and identify preoperative and early postoperative factors associated with long term outcome.
Read the detailed description
All patients follow the same fast-track program including same day surgery for elective knee replacement surgery at the Silkeborg Regional Hospital in Denmark, which includes detailed preoperative written information, multidisciplinary education course for patients and relatives, optimized multimodal pain treatment and early postoperative rehabilitation. Before the admission for surgery, patients will be asked to fulfill several questionnaires and baseline information regarding work situation, educational level and previous treatments. At two weeks there, there is a scheduled follow up by a physical therapist and a nurse at the hospital. At three months there is a scheduled follow up by telephone with a physical therapist.
The study will adhere methodologically to the STROBE guidelines and checklist for prospective cohort studies (www.strobe-statement.org).
Further description is provided elsewhere as eligibility criteria and outcome measures.
Addition to the description:
In January 2019 we started collecting 1 year follow-up data and included questions regarding treatment success, satisfaction and willingness to repeat the surgery.
In March 2019 we decided to make a change in the baseline collection of relevant predictors for primary outcome. The reason for the change was to be able to answer more relevant scientific questions in the cohort study. We replaced "The General Self-efficacy Scale" with "Pain Catastrophizing Scale" and excluded "The General Self-efficacy Scale" from the 12 weeks follow-up collection of outcome measures.
March 2020:
The SIKS study was planned to continue recruitment until reaching minimum 1,000 TKA patients with follow-up data which was deemed sufficient for the purpose of the planned studies. In March 2020, the COVID-19 pandemic closed down all elective orthopaedic surgeries. Because of that, we decided to stop the recruitment to the cohort study with the last patient included (at March 16th, 2020, prior to the COVID-19 lockdown).
December 2020:
The first substudies are planned using data from the SIKS cohort:
- Predictors of knee pain and functional outcome following Total Knee Arthroplasty - a prospective cohort study with 12 months follow up Primary outcome: Oxford Knee Score at 12 months
- Is it feasible and safe to discharge patients on the day of surgery after a total knee arthroplasty? Primary outcomes Feasibility measured as length of stay Safety measures as readmission (phone calls, outpatient visits and inpatient visits) and the related reason Secondary outcomes Oxfort knee score (90 days) Pain intensity (90 days)
- Associations between preoperative BMI and postoperative physical activity level and functional capacity 12 months after UKA or TKA surgery. Primary outcome UCLA scale (12 months) Secondary outcomes Oxford Knee Score (12 months) February 2024
- Opioid use at 3 and 12 months following primary knee arthroplasty: a prospective cohort study
Primary outcome: Patient-reported use of opioids 3 and 12 months after knee arthroplasty.
Secondary outcome: Patient-reported causes for opioid use 3 and 12 months after knee arthroplasty.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Total or unicompartmental knee replacement
- Keywords
- Rehabilitation, Recovery of function, Outcome Assessment (Health Care), Patient Reported outcome Measures, Treatment Outcome, Pain, Postoperative, Pain Management, Orthopedic Surgery
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total or unicompartmental knee replacementProcedure or surgery
Fast-track Knee replacement surgery including same day surgery
| Study group | Role | What they receive |
|---|---|---|
| Knee replacement | Patients assigned for total or unicompartmental knee replacement surgery Receives: Procedure: Total or unicompartmental knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score (OKS) (continous)
Disease specific Patient Reported Outcome Measure regarding function and pain. Each question is answered by ticking a box on a five-point Likert scale. Responses are then totalled to obtain a score between 0 and 48, with 48 being the best.
Measured: 52 weeks after surgery
Secondary outcomes (25)
Oxford Knee Score (OKS) (continous)
Disease specific Patient Reported Outcome Measure regarding function and pain. Each question is answered by ticking a box on a five-point Likert scale. Responses are then totalled to obtain a score between 0 and 48, with 48 being the best.
Measured: Pre surgery
Oxford Knee Score (OKS) (continous)
Disease specific Patient Reported Outcome Measure regarding function and pain. Each question is answered by ticking a box on a five-point Likert scale. Responses are then totalled to obtain a score between 0 and 48, with 48 being the best
Measured: 12 weeks after surgery
EQ-5D-5L (continous)
Generic Health Related Quality of Life Patient Reported Outcome Measure
Measured: Pre surgery
EQ-5D-5L (continous)
Generic Health Related Quality of Life Patient Reported Outcome Measure
Measured: 12 weeks after surgery
EQ-5D-5L (continous)
Generic Health Related Quality of Life Patient Reported Outcome Measure
Measured: 52 weeks after surgery
The General Self-efficacy Scale (continous)
A generic Patient Reported Outcome Measure. The General Self-efficacy Scale measures self-efficacy, defined as an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments.Each question is answered by ticking a box on a four-point Likert scale. Responses are then totalled to obtain a score between 10 and 40, with 40 being the best. he General Self-efficacy Scale measures self-efficacy, defined as an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments.Each question is answered by ticking a box on a four-point Likert scale. Responses are then totalled to obtain a score between 10 and 40, with 40 being the best. The General Self-efficacy Scale is included in the data collection from January 2019 til March 2019, which corresponds to about 550 patient responds.
Measured: Pre surgery
The General Self-efficacy Scale (continous)
A generic Patient Reported Outcome Measure. The General Self-efficacy Scale measures self-efficacy, defined as an individual's belief in his or her capacity to execute behaviors necessary to produce specific performance attainments. Each question is answered by ticking a box on a four-point Likert scale. Responses are then totalled to obtain a score between 10 and 40, with 40 being the best. The General Self-efficacy Scale is included in the data collection from January 2019 til June 2019, which corresponds to about 550 patient responds
Measured: 12 weeks after surgery
Pain Visual Analog Scale (VAS) (continous)
Measured in rest and activity. The pain VAS is a generic pain measure on a continuous scale comprised of a horizontal line orientated from the left (worst) to the right (best), 100 mm in length
Measured: Pre surgery
Pain Visual Analog Scale (VAS) (continous)
Measured in rest and activity. The pain VAS is a generic pain measure on a continuous scale comprised of a horizontal line orientated from the left (worst) to the right (best), 100 mm in length
Measured: 12 weeks after surgery
Pain Visual Analog Scale (VAS) (continous)
Measured in rest and activity. The pain VAS is a generic pain measure on a continuous scale comprised of a horizontal line orientated from the left (worst) to the right (best), 100 mm in length
Measured: 52 weeks after surgery
Analgetic pain medication intake (type and frequence)
Self-reported by the patients
Measured: Pre surgery
Analgetic pain medication intake (type and frequence)
Self-reported by the patients
Measured: 12 weeks after surgery
Analgetic pain medication intake (type and frequence)
Self-reported by the patients
Measured: 52 weeks after surgery
Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
Measures is conducted by a doctor
Measured: Pre surgery
UCLA Activity Scale (continuous)
Patient Reported Outcome Measure, that measures physical activity in patients with knee replacements on a 10-level scale, where "10" is very active
Measured: Pre surgery
UCLA Activity Scale (continuous)
Patient Reported Outcome Measure, that measures physical activity in patients with knee replacements on a 10-level scale, where "10" is very active
Measured: 12 weeks after surgery
UCLA Activity Scale (continuous)
Patient Reported Outcome Measure, that measures physical activity in patients with knee replacements on a 10-level scale, where "10" is very active
Measured: 52 weeks after surgery
Pain Catastrophizing Scale (PCS)
Patient Reported Outcome Measure, that measures how patients experience pain. Pain catastrophizing is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event such as surgery for example. Each of the 13 questions is answered by ticking a box on a 5 point Likert Scale from 0 (not at all) to 4 (all the time). A total score is yielded (ranging from 0-52 and 0 being the best), along with three subscale scores assessing rumination, magnification and helplessness. The PCS is included in the data collection from March 2019 til end of the cohort study, which corresponds to about 950 patient responses (instead of The General Self-efficacy Scale)
Measured: Pre surgery
Global Perceived Effect (GPE)
GPE measures patients' perception of the change in their knee problems after the surgery. GPE will be assessed with the anchor question "Overall, how are the problems now (pain and ability to perform daily activities) in the knee on which you had surgery, compared to prior to your operation?" Patients respond on a 7-point scale ranging from "better, an important improvement" to "worse, an important deterioration".
Measured: 52 weeks after surgery
Satisfaction with the surgery
Satisfaction is measured with the question "Overall, how satisfied are you with the sugery?". Patients respond on a 5 point scale ranging from "very satisfied" to "very unsatisfied"
Measured: 52 weeks after surgery
Patient Acceptable Symptom State (PASS)
PASS measures satisfaction with the current knee function and will be assessed with the anchor question ""When you think of your knee function, will you consider your current condition as satisfying? With knee function, you should take into account your activities of daily living, your level of pain and other symptoms". Patients respond "yes" or "no". If patients respond "no" they are asked if the consider the treatment of ther knee problem as a failure.
Measured: 52 weeks after surgery
Global assessment of willingness to repeat the surgery
Assessed with the anchor question "knowing what your knee arthroplasty surgery did for you, if you could go back in time, would you still have undergone this surgery?" Patients respond "yes", "no" or "uncertain".
Measured: 52 weeks after surgery
Feasibility (length of stay)
Measured as length of stay and reason for not being discharged on post operative day 0 (same-day) will be provided.
Measured: 2 weeks after surgery
Safety (readmission)
- number of patient-initiated phone calls
- number of unscheduled visits in the outpatient clinic
- number of inpatient readmission (admission to hospital ward taking up a bed)
Measured: 1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
Safety (complications)
The reason for readmission (=complication) in relation to:
- patient-initiated phone calls
- unscheduled visits in the outpatient clinic
- inpatient readmission (admission to hospital ward taking up a bed) will be reported.
Measured: 1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Feb 2018
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lone Ramer Mikkelsen, Msc., Ph.D., Principal investigator, Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, DenmarkMette Garval, PT, Msc., Principal investigator, Physical Therapy Department, Elective Surgery Centre Silkeborg Regional Hospital, DenmarkSøren Thorgaard Skou, PT, PhD, Study chair, Research Unit for Musculoskeletal Function and Physiotherapy University of Southern DenmarkAnne Mette Schmidt, Msc., Ph.D., Principal investigator, Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411083
- Sponsor's protocol ID
- 6500009
- Status last verified
- May 2020
- First submitted
- 19 Jan 2018
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silkeborg Knee Replacement Cohort Study
- ClinicalTrials.gov ID
- NCT03411083
- Acronym / sponsor ID
- 6500009
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Rehabilitation, Recovery of function, Outcome Assessment (Health Care), Patient Reported outcome Measures, Treatment Outcome, Pain, Postoperative, Pain Management, Orthopedic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,225 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 25 Jan 2018 (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.
In this cohort study, we will investigate short and long term outcomes after knee replacement surgery and identify preoperative and early postoperative factors associated with long term outcome.
Detailed description
All patients follow the same fast-track program including same day surgery for elective knee replacement surgery at the Silkeborg Regional Hospital in Denmark, which includes detailed preoperative written information, multidisciplinary education course for patients and relatives, optimized multimodal pain treatment and early postoperative rehabilitation. Before the admission for surgery, patients will be asked to fulfill several questionnaires and baseline information regarding work situation, educational level and previous treatments. At two weeks there, there is a scheduled follow up by a physical therapist and a nurse at the hospital. At three months there is a scheduled follow up by telephone with a physical therapist.
The study will adhere methodologically to the STROBE guidelines and checklist for prospective cohort studies (www.strobe-statement.org).
Further description is provided elsewhere as eligibility criteria and outcome measures.
Addition to the description:
In January 2019 we started collecting 1 year follow-up data and included questions regarding treatment success, satisfaction and willingness to repeat the surgery.
In March 2019 we decided to make a change in the baseline collection of relevant predictors for primary outcome. The reason for the change was to be able to answer more relevant scientific questions in the cohort study. We replaced "The General Self-efficacy Scale" with "Pain Catastrophizing Scale" and excluded "The General Self-efficacy Scale" from the 12 weeks follow-up collection of outcome measures.
March 2020:
The SIKS study was planned to continue recruitment until reaching minimum 1,000 TKA patients with follow-up data which was deemed sufficient for the purpose of the planned studies. In March 2020, the COVID-19 pandemic closed down all elective orthopaedic surgeries. Because of that, we decided to stop the recruitment to the cohort study with the last patient included (at March 16th, 2020, prior to the COVID-19 lockdown).
December 2020:
The first substudies are planned using data from the SIKS cohort:
- Predictors of knee pain and functional outcome following Total Knee Arthroplasty - a prospective cohort study with 12 months follow up Primary outcome: Oxford Knee Score at 12 months
- Is it feasible and safe to discharge patients on the day of surgery after a total knee arthroplasty? Primary outcomes Feasibility measured as length of stay Safety measures as readmission (phone calls, outpatient visits and inpatient visits) and the related reason Secondary outcomes Oxfort knee score (90 days) Pain intensity (90 days)
- Associations between preoperative BMI and postoperative physical activity level and functional capacity 12 months after UKA or TKA surgery. Primary outcome UCLA scale (12 months) Secondary outcomes Oxford Knee Score (12 months) February 2024
- Opioid use at 3 and 12 months following primary knee arthroplasty: a prospective cohort study
Primary outcome: Patient-reported use of opioids 3 and 12 months after knee arthroplasty.
Secondary outcome: Patient-reported causes for opioid use 3 and 12 months after knee arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee replacement | – | Procedure: Total or unicompartmental knee replacementPatients assigned for total or unicompartmental knee replacement surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assigned for primary knee replacement in the period from February 2018 to May 2020 will be consecutively recruited to the cohort from Silkeborg Regional Hospital Denmark.
Key inclusion criteria (3 listed)
- Assigned for primary Unicompartmental or Total Knee Replacement
- Age ≥ 18 years at the time of recruitment
- Able to read and understand Danish
Key exclusion criteria (1 listed)
- Not mentally able to reply to the questionnaire
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 |
|---|---|---|
| Total or unicompartmental knee replacementFast-track Knee replacement surgery including same day surgery | Procedure or surgery | Knee replacement |
Primary outcome
Oxford Knee Score (OKS) (continous)
Time frame: 52 weeks after surgery
Disease specific Patient Reported Outcome Measure regarding function and pain. Each question is answered by ticking a box on a five-point Likert scale. Responses are then totalled to obtain a score between 0 and 48, with 48 being the best.
25 secondary outcomes
Oxford Knee Score (OKS) (continous)
Time frame: Pre surgery
Oxford Knee Score (OKS) (continous)
Time frame: 12 weeks after surgery
EQ-5D-5L (continous)
Time frame: Pre surgery
EQ-5D-5L (continous)
Time frame: 12 weeks after surgery
EQ-5D-5L (continous)
Time frame: 52 weeks after surgery
The General Self-efficacy Scale (continous)
Time frame: Pre surgery
The General Self-efficacy Scale (continous)
Time frame: 12 weeks after surgery
Pain Visual Analog Scale (VAS) (continous)
Time frame: Pre surgery
Pain Visual Analog Scale (VAS) (continous)
Time frame: 12 weeks after surgery
Pain Visual Analog Scale (VAS) (continous)
Time frame: 52 weeks after surgery
Analgetic pain medication intake (type and frequence)
Time frame: Pre surgery
Analgetic pain medication intake (type and frequence)
Time frame: 12 weeks after surgery
Analgetic pain medication intake (type and frequence)
Time frame: 52 weeks after surgery
Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
Time frame: Pre surgery
UCLA Activity Scale (continuous)
Time frame: Pre surgery
UCLA Activity Scale (continuous)
Time frame: 12 weeks after surgery
UCLA Activity Scale (continuous)
Time frame: 52 weeks after surgery
Pain Catastrophizing Scale (PCS)
Time frame: Pre surgery
Global Perceived Effect (GPE)
Time frame: 52 weeks after surgery
Satisfaction with the surgery
Time frame: 52 weeks after surgery
Patient Acceptable Symptom State (PASS)
Time frame: 52 weeks after surgery
Global assessment of willingness to repeat the surgery
Time frame: 52 weeks after surgery
Feasibility (length of stay)
Time frame: 2 weeks after surgery
Safety (readmission)
Time frame: 1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
Safety (complications)
Time frame: 1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
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 21 Feb 2025.
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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.
Lone Ramer Mikkelsen, Msc., Ph.D. principal investigator
Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark
Mette Garval, PT, Msc. principal investigator
Physical Therapy Department, Elective Surgery Centre Silkeborg Regional Hospital, Denmark
Søren Thorgaard Skou, PT, PhD study chair
Research Unit for Musculoskeletal Function and Physiotherapy University of Southern Denmark
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 Arthroplasty, Replacement, Knee, run by Central Jutland Regional 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 3 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 21 Feb 2025. 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?
Oxford Knee Score (OKS) (continous) (time frame: 52 weeks after surgery). 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 21 Feb 2025.