- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04665180
Determinants for Return to Work After Primary Knee Arthroplasty (RTW)
Determinants for Return to Work After Primary Knee Arthroplasty: a Prospective Study
The increase of end-stage osteoarthritis (OA) in an increasingly younger population is directly correlated with the rising incidence of obesity. As a result, knee arthroplasty (KA), which is a definitive end-stage treatment option, is increasingly performed on working age people. Knowledge and understanding of the underlying factors that drive the ability for people to return to work is crucial.
First and foremost, the investigators would have like to have a clear idea of the percentage of patients who return to work and at what time postoperatively. The investigators would also determine the different factors influencing employment in the patient population after undergoing a knee arthroplasty and register the evolution in the necessity of pain medication pre-and postoperatively. Ideally, the investigators can include a short questionnaire regarding return to sports to gather valuable information.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The increase of end-stage osteoarthritis (OA) in an increasingly younger population is directly correlated with the rising incidence of obesity. As a result, knee arthroplasty (KA), which is a definitive end-stage treatment option, is increasingly performed on working age people. Knowledge and understanding of the underlying factors that drive the ability for people to return to work is crucial.
First and foremost, the investigators would have like to have a clear idea of the percentage of patients who return to work and at what time postoperatively. The investigators would also determine the different factors influencing employment in the patient population after undergoing a knee arthroplasty and register the evolution in the necessity of pain medication pre-and postoperatively. Ideally, the investigators can include a short questionnaire regarding return to sports to gather valuable information.
Adult patients with an indication for primary knee arthroplasty (total + unicondylar) can take part in the study. This will be decided by clinical examination and radiographic evaluation, having the result of the previous therapies and the patient-specific needs in mind (standard of care). The patients have to be younger than or equal to 63 years old at the time of surgery and actively been working 2 years prior to surgery.
In line with the standard of care, the patients will be seen after 4-8 weeks, 3-4 months and 1 year postoperatively. Radiological examinations are foreseen at 4-8 weeks and 1 year postoperatively (standard of care). Pre-operatively, a general questionnaire is filled in by the patients. The patient questionnaires Knee Society Score (KSS), Knee Injury and Osteoarthritis Outcome Score (KOOS), Forgotten Knee Joint Score, Quickscan, Work, Osteoarthritis and joint-Replacement Questionnaire (WORQ) will be filled in by the patients during the screening visit and on each consultation at 4-8 weeks, 3-4 months, 6 months, 1 year and 1,5 year. The Tegner score will be filled in by the patients pre-operatively and at 1 year postoperatively.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- UZ Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Informed consent
- Primary knee arthroplasty (total + unicondylar)
- Patients younger than or equal to 63 years old at the time of surgery
- Actively been working 2 year prior to surgery.
Exclusion Criteria:
- No informed consent
- Revision surgery
- Patients older than 63 years of age at the time of surgery
- Patients who haven't were unable to work due to other, non-knee related, health issues
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Primary knee arthroplasty
Questionnaires
|
Patients who return to work after primary knee arthroplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quickscan questionnaire
Time Frame: Time frame of 1,5 year postoperatively
|
Return to work is measured using the Quickscan questionnaire during screening visit, at 4-8 weeks, 3-4 months, 6 months, 1 year and 1,5 year. In the Quickscan questionnaire, all questions are scored ranging from "0" totally disagree to "5" totally agree. |
Time frame of 1,5 year postoperatively
|
|
Work, Osteoarthritis and joint-Replacement Questionnaire (WORQ)
Time Frame: Time frame of 1,5 year postoperatively
|
Return to work is measured using the Work, Osteoarthritis and joint-Replacement Questionnaire (WORQ) during screening visit, at 4-8 weeks, 3-4 months, 6 months, 1 year and 1,5 year. The WORQ is a patient reported outcome measure (PROM) in which the patient indicates his experiences in 13 knee-stressing activities in the past week by scoring the difficulty the patient experienced. A formula is used to calculate the total score that ranges from 0 ('very much difficulty/ can't do') to 4 ('no difficulty at all'). |
Time frame of 1,5 year postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee rate and patient's functional abilities
Time Frame: within a time frame of 1,5 year postoperatively
|
To rate the knee and patient's functional abilities, the Knee Society Score (KSS) is used during screening visit, at 4-8 weeks, 3-4 months, 6 months, 1 year and 1,5 year.
|
within a time frame of 1,5 year postoperatively
|
|
Knee symptoms
Time Frame: within a time frame of 1,5 year postoperatively
|
Knee symptoms are measured using Knee Injury and Osteoarthritis Outcome Score (KOOS) during screening visit, at 4-8 weeks, 3-4 months, 6 months, 1 year and 1,5 year.
|
within a time frame of 1,5 year postoperatively
|
|
Awareness of knee joint/knee prothesis in daily life
Time Frame: within a time frame of 1,5 year postoperatively
|
Be aware of knee joint/knee prothesis in daily life is measured using the Forgotten Knee Joint Score during screening visit, at 4-8 weeks, 3-4 months, 6 months, 1 year and 1,5 year.
|
within a time frame of 1,5 year postoperatively
|
|
Return to sports
Time Frame: within a time frame of 1 year postoperatively
|
Return to sports is measured using the Tegner score during screening visit and at 1 year postoperatively.
|
within a time frame of 1 year postoperatively
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hilde Vandenneucker, Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- S63495
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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