- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03411083
Silkeborg Knee Replacement Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jutland
-
Silkeborg, Jutland, Denmark, 8600
- Silkeborg Regional Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Assigned for primary Unicompartmental or Total Knee Replacement
- Age ≥ 18 years at the time of recruitment
- Able to read and understand Danish
Exclusion Criteria:
- Not mentally able to reply to the questionnaire
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Knee replacement
Patients assigned for total or unicompartmental knee replacement surgery
|
Fast-track Knee replacement surgery including same day surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
52 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxford Knee Score (OKS) (continous)
Time Frame: Pre 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.
|
Pre surgery
|
Oxford Knee Score (OKS) (continous)
Time Frame: 12 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
|
12 weeks after surgery
|
EQ-5D-5L (continous)
Time Frame: Pre surgery
|
Generic Health Related Quality of Life Patient Reported Outcome Measure
|
Pre surgery
|
EQ-5D-5L (continous)
Time Frame: 12 weeks after surgery
|
Generic Health Related Quality of Life Patient Reported Outcome Measure
|
12 weeks after surgery
|
EQ-5D-5L (continous)
Time Frame: 52 weeks after surgery
|
Generic Health Related Quality of Life Patient Reported Outcome Measure
|
52 weeks after surgery
|
The General Self-efficacy Scale (continous)
Time Frame: Pre surgery
|
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.
|
Pre surgery
|
The General Self-efficacy Scale (continous)
Time Frame: 12 weeks after surgery
|
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
|
12 weeks after surgery
|
Pain Visual Analog Scale (VAS) (continous)
Time Frame: Pre surgery
|
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
|
Pre surgery
|
Pain Visual Analog Scale (VAS) (continous)
Time Frame: 12 weeks after surgery
|
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
|
12 weeks after surgery
|
Pain Visual Analog Scale (VAS) (continous)
Time Frame: 52 weeks after surgery
|
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
|
52 weeks after surgery
|
Analgetic pain medication intake (type and frequence)
Time Frame: Pre surgery
|
Self-reported by the patients
|
Pre surgery
|
Analgetic pain medication intake (type and frequence)
Time Frame: 12 weeks after surgery
|
Self-reported by the patients
|
12 weeks after surgery
|
Analgetic pain medication intake (type and frequence)
Time Frame: 52 weeks after surgery
|
Self-reported by the patients
|
52 weeks after surgery
|
Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
Time Frame: Pre surgery
|
Measures is conducted by a doctor
|
Pre surgery
|
UCLA Activity Scale (continuous)
Time Frame: Pre surgery
|
Patient Reported Outcome Measure, that measures physical activity in patients with knee replacements on a 10-level scale, where "10" is very active
|
Pre surgery
|
UCLA Activity Scale (continuous)
Time Frame: 12 weeks after surgery
|
Patient Reported Outcome Measure, that measures physical activity in patients with knee replacements on a 10-level scale, where "10" is very active
|
12 weeks after surgery
|
UCLA Activity Scale (continuous)
Time Frame: 52 weeks after surgery
|
Patient Reported Outcome Measure, that measures physical activity in patients with knee replacements on a 10-level scale, where "10" is very active
|
52 weeks after surgery
|
Pain Catastrophizing Scale (PCS)
Time Frame: Pre surgery
|
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)
|
Pre surgery
|
Global Perceived Effect (GPE)
Time Frame: 52 weeks after surgery
|
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".
|
52 weeks after surgery
|
Satisfaction with the surgery
Time Frame: 52 weeks after 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"
|
52 weeks after surgery
|
Patient Acceptable Symptom State (PASS)
Time Frame: 52 weeks after surgery
|
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.
|
52 weeks after surgery
|
Global assessment of willingness to repeat the surgery
Time Frame: 52 weeks after 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".
|
52 weeks after surgery
|
Feasibility (length of stay)
Time Frame: 2 weeks after surgery
|
Measured as length of stay and reason for not being discharged on post operative day 0 (same-day) will be provided.
|
2 weeks after surgery
|
Safety (readmission)
Time Frame: 1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
|
|
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
|
The reason for readmission (=complication) in relation to:
|
1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Visual Analog Scale (VAS) (continous)
Time Frame: 2 weeks after surgery
|
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
|
2 weeks after surgery
|
Analgetic pain medication intake (type and frequence)
Time Frame: 2 weeks after surgery
|
Registrated by a nurse
|
2 weeks after surgery
|
Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
Time Frame: 2 weeks after surgery
|
Measures is conducted by a physical therapist
|
2 weeks after surgery
|
Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
Time Frame: pre surgery
|
Measures is conducted by a doctor
|
pre surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lone Ramer Mikkelsen, Msc., Ph.D., Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark
- Principal Investigator: Mette Garval, PT, Msc., Physical Therapy Department, Elective Surgery Centre Silkeborg Regional Hospital, Denmark
- Study Chair: Søren Thorgaard Skou, PT, PhD, Research Unit for Musculoskeletal Function and Physiotherapy University of Southern Denmark
- Principal Investigator: Anne Mette Schmidt, Msc., Ph.D., Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6500009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthroplasty, Replacement, Knee
-
Fondazione Don Carlo Gnocchi OnlusCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipItaly
-
Bornholms RegionskommuneCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipDenmark
-
Central DuPage HospitalTerminatedTotal Knee Replacement | Replacement, Total Knee | Arthroplasty, Knee ReplacementUnited States
-
Campus Bio-Medico UniversityRecruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipItaly
-
SCRI Development Innovations, LLCWithdrawnArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
-
Sunnybrook Health Sciences CentreActive, not recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipCanada
-
University of British ColumbiaThe Arthritis Society, Canada; Centre for Aging SMART; Centre for Advancing Health...Not yet recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipCanada
-
University Hospital, Strasbourg, FranceRecruitingArthroplasty, Hip Replacement | Arthroplasty, Knee ReplacementFrance
-
Henry Ford Health SystemConsumer Sleep SolutionsNot yet recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
-
Haute Ecole de Santé VaudCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipSwitzerland
Clinical Trials on Total or unicompartmental knee replacement
-
University of OxfordUniversity of AberdeenActive, not recruiting
-
Karolinska InstitutetRecruitingUnicondylar- or Total Knee Replacement? Patient Satisfaction, Function and Muscle Mass (UKA or TKA?)Knee OsteoarthritisSweden
-
Rennes University HospitalCompleted
-
Oxford University Hospitals NHS TrustCompletedOsteoarthritis, Knee
-
University of OxfordUnknownArthroplasty, Replacement, KneeUnited Kingdom
-
Anderson Orthopaedic Research InstituteRush University Medical CenterActive, not recruiting
-
Assiut UniversityCompletedKnee Osteoarthritis | Knee ArthroplastyEgypt
-
Hvidovre University HospitalParker Research Institute; Frederiksberg University HospitalRecruitingArthritis | Knee Osteoarthritis | Surgery | Total Knee Arthroplasty | Unicompartmental Knee ArthroplastyDenmark
-
Mayo ClinicCompleted
-
Ottawa Hospital Research InstituteWithdrawnOsteoarthritis, KneeCanada