Clinical trial NCT03411083: Silkeborg Knee Replacement Cohort Study
Official title: Silkeborg Knee Replacement Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 1225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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:

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)

   February 2024
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxford Knee Score (OKS) (continous)
timeFrame: 52 weeks after surgery
Secondary outcomes:
measure: Oxford Knee Score (OKS) (continous)
timeFrame: Pre surgery
measure: Oxford Knee Score (OKS) (continous)
timeFrame: 12 weeks after surgery
measure: EQ-5D-5L (continous)
timeFrame: Pre surgery
measure: EQ-5D-5L (continous)
timeFrame: 12 weeks after surgery
measure: EQ-5D-5L (continous)
timeFrame: 52 weeks after surgery
measure: The General Self-efficacy Scale (continous)
timeFrame: Pre surgery
measure: The General Self-efficacy Scale (continous)
timeFrame: 12 weeks after surgery
measure: Pain Visual Analog Scale (VAS) (continous)
timeFrame: Pre surgery
measure: Pain Visual Analog Scale (VAS) (continous)
timeFrame: 12 weeks after surgery
measure: Pain Visual Analog Scale (VAS) (continous)
timeFrame: 52 weeks after surgery
measure: Analgetic pain medication intake (type and frequence)
timeFrame: Pre surgery
measure: Analgetic pain medication intake (type and frequence)
timeFrame: 12 weeks after surgery
measure: Analgetic pain medication intake (type and frequence)
timeFrame: 52 weeks after surgery
measure: Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
timeFrame: Pre surgery
measure: UCLA Activity Scale (continuous)
timeFrame: Pre surgery
measure: UCLA Activity Scale (continuous)
timeFrame: 12 weeks after surgery
measure: UCLA Activity Scale (continuous)
timeFrame: 52 weeks after surgery
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Pre surgery
measure: Global Perceived Effect (GPE)
timeFrame: 52 weeks after surgery
measure: Satisfaction with the surgery
timeFrame: 52 weeks after surgery
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 52 weeks after surgery
measure: Global assessment of willingness to repeat the surgery
timeFrame: 52 weeks after surgery
measure: Feasibility (length of stay)
timeFrame: 2 weeks after surgery
measure: Safety (readmission)
timeFrame: 1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
measure: Safety (complications)
timeFrame: 1) 2 weeks after surgery, 2) 2 weeks after surgery, and 3) 90 days after discharge
Other outcomes:
measure: Pain Visual Analog Scale (VAS) (continous)
timeFrame: 2 weeks after surgery
measure: Analgetic pain medication intake (type and frequence)
timeFrame: 2 weeks after surgery
measure: Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
timeFrame: 2 weeks after surgery
measure: Range of Motion (ROM) in passive knee flexion and passive knee extension (degrees)
timeFrame: pre surgery
Locations:
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
state: Jutland
Study officials:
affiliation: Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark
name: Lone Ramer Mikkelsen, Msc., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Physical Therapy Department, Elective Surgery Centre Silkeborg Regional Hospital, Denmark
name: Mette Garval, PT, Msc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Unit for Musculoskeletal Function and Physiotherapy University of Southern Denmark
name: Søren Thorgaard Skou, PT, PhD
role: STUDY_CHAIR
affiliation: Interdisciplinary Research Unit Elective Surgery Centre Silkeborg Regional Hospital, Denmark
name: Anne Mette Schmidt, Msc., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: