Silkeborg Knee Replacement Cohort Study

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Silkeborg Knee Replacement Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411083
• Other study ID #: 6500009
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: March 23, 2021

Study information

• Verified date: May 2020
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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:

1. 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

2. 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)

3. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225
• Est. completion date: March 23, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Procedure:
• Total or unicompartmental knee replacement
Fast-track Knee replacement surgery including same day surgery

Locations

Country	Name	City	State
Denmark	Silkeborg Regional Hospital	Silkeborg	Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	2 weeks after surgery
Other	Analgetic pain medication intake (type and frequence)	Registrated by a nurse	2 weeks after surgery
Other	Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)	Measures is conducted by a physical therapist	2 weeks after surgery
Other	Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)	Measures is conducted by a doctor	pre surgery
Primary	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.	52 weeks after surgery
Secondary	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.	Pre surgery
Secondary	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	12 weeks after surgery
Secondary	EQ-5D-5L (continous)	Generic Health Related Quality of Life Patient Reported Outcome Measure	Pre surgery
Secondary	EQ-5D-5L (continous)	Generic Health Related Quality of Life Patient Reported Outcome Measure	12 weeks after surgery
Secondary	EQ-5D-5L (continous)	Generic Health Related Quality of Life Patient Reported Outcome Measure	52 weeks after surgery
Secondary	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.	Pre surgery
Secondary	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	12 weeks after surgery
Secondary	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	Pre surgery
Secondary	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	12 weeks after surgery
Secondary	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	52 weeks after surgery
Secondary	Analgetic pain medication intake (type and frequence)	Self-reported by the patients	Pre surgery
Secondary	Analgetic pain medication intake (type and frequence)	Self-reported by the patients	12 weeks after surgery
Secondary	Analgetic pain medication intake (type and frequence)	Self-reported by the patients	52 weeks after surgery
Secondary	Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)	Measures is conducted by a doctor	Pre surgery
Secondary	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	Pre surgery
Secondary	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	12 weeks after surgery
Secondary	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	52 weeks after surgery
Secondary	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)	Pre surgery
Secondary	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".	52 weeks after surgery
Secondary	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"	52 weeks after surgery
Secondary	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.	52 weeks after surgery
Secondary	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".	52 weeks after surgery
Secondary	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.	2 weeks after surgery
Secondary	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)	1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
Secondary	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.	1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge