Determinants for Return to Work After Primary Knee Arthroplasty

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Recruiting
CT.gov ID
NCT04665180
Collaborator
(none)
200
1
1
46.6
4.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Primary knee arthroplasty
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Determinants for Return to Work After Primary Knee Arthroplasty: a Prospective Study
Actual Study Start Date :
Jan 12, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Primary knee arthroplasty

Questionnaires

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

Outcome Measures

Primary Outcome Measures

  1. Return to work after primary knee arthroplasty [within a 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.

  2. Return to work after primary knee arthroplasty [within a 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.

Secondary Outcome Measures

  1. Knee rate and patient's functional abilities [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.

  2. Knee symptoms [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.

  3. Awareness of knee joint/knee prothesis in daily life [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.

  4. Return to sports [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 63 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Leuven Leuven Vlaams-Brabant Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04665180
Other Study ID Numbers:
  • S63495
First Posted:
Dec 11, 2020
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2021