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Determinants for Return to Work After Primary Knee Arthroplasty (RTW)

Primary Purpose

Knee Arthropathy, Return to Work

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Primary knee arthroplasty
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Knee Arthropathy

Eligibility Criteria

18 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary knee arthroplasty

Arm Description

Questionnaires

Outcomes

Primary Outcome Measures

Quickscan questionnaire
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.
Work, Osteoarthritis and joint-Replacement Questionnaire (WORQ)
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').

Secondary Outcome Measures

Knee rate and patient's functional abilities
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.
Knee symptoms
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.
Awareness of knee joint/knee prothesis in daily life
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.
Return to sports
Return to sports is measured using the Tegner score during screening visit and at 1 year postoperatively.

Full Information

First Posted
December 1, 2020
Last Updated
September 22, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04665180
Brief Title
Determinants for Return to Work After Primary Knee Arthroplasty
Acronym
RTW
Official Title
Determinants for Return to Work After Primary Knee Arthroplasty: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy, Return to Work

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary knee arthroplasty
Arm Type
Experimental
Arm Description
Questionnaires
Intervention Type
Diagnostic Test
Intervention Name(s)
Primary knee arthroplasty
Intervention Description
Patients who return to work after primary knee arthroplasty
Primary Outcome Measure Information:
Title
Quickscan questionnaire
Description
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
Time frame of 1,5 year postoperatively
Title
Work, Osteoarthritis and joint-Replacement Questionnaire (WORQ)
Description
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
Time frame of 1,5 year postoperatively
Secondary Outcome Measure Information:
Title
Knee rate and patient's functional abilities
Description
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.
Time Frame
within a time frame of 1,5 year postoperatively
Title
Knee symptoms
Description
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.
Time Frame
within a time frame of 1,5 year postoperatively
Title
Awareness of knee joint/knee prothesis in daily life
Description
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.
Time Frame
within a time frame of 1,5 year postoperatively
Title
Return to sports
Description
Return to sports is measured using the Tegner score during screening visit and at 1 year postoperatively.
Time Frame
within a time frame of 1 year postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilde Vandenneucker
Phone
+32 16 33 88 16
Email
hilde.vandenneucker@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Pieter Berger
Phone
+32 16 33 88 71
Email
pieter.berger@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilde Vandenneucker
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilde Vandenneucker
Phone
+32 16 33 88 16
Email
hilde.vandenneucker@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Pieter Berger
Phone
+32 16 33 88 71
Email
pieter.berger@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Hilde Vandenneucker
First Name & Middle Initial & Last Name & Degree
Pieter Berger
First Name & Middle Initial & Last Name & Degree
Anthony Timmerman
First Name & Middle Initial & Last Name & Degree
Lode Godderis

12. IPD Sharing Statement

Plan to Share IPD
No

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Determinants for Return to Work After Primary Knee Arthroplasty

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