Determinants for Return to Work After Primary Knee Arthroplasty

NCT04665180 | Active Not Recruiting

• 1 other identifier: S63495
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthropathy; Return to Work

Outcome Measures

Primary Outcomes (2)

• 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.

  Time frame of 1,5 year postoperatively

• 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').

  Time frame of 1,5 year postoperatively

Secondary Outcomes (4)

• Knee rate and patient's functional abilities

  within a time frame of 1,5 year postoperatively

• Knee symptoms

  within a time frame of 1,5 year postoperatively

• Awareness of knee joint/knee prothesis in daily life

  within a time frame of 1,5 year postoperatively

• Return to sports

  within a time frame of 1 year postoperatively

Study Arms (1)

Primary knee arthroplasty

EXPERIMENTAL

Questionnaires

Diagnostic Test: Primary knee arthroplasty

Interventions

Primary knee arthroplasty DIAGNOSTIC_TEST

Patients who return to work after primary knee arthroplasty

Primary knee arthroplasty

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Officials

• Hilde Vandenneucker

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 11, 2020
• Study Start: January 12, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)