Determinants for Return to Work After Primary Knee Arthroplasty

Knee Arthropathy Clinical Trial

— RTW  

Official title:

Determinants for Return to Work After Primary Knee Arthroplasty: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665180
• Other study ID #: S63495
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Hilde Vandenneucker
• Phone: +32 16 33 88 16
• Email: hilde.vandenneucker[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 63 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy
• Return to Work

Intervention

Diagnostic Test:
• Primary knee arthroplasty
Patients who return to work after primary knee arthroplasty

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	within a time frame of 1,5 year postoperatively
Secondary	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.	within a time frame of 1,5 year postoperatively
Secondary	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.	within a time frame of 1,5 year postoperatively
Secondary	Return to sports	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