The Effects of Surgical Wait Time for Knee Arthroplasty Quality of Life in Patients Awaiting Knee Arthroplasty (SIT'NWAIT)

December 11, 2023 updated by: Dijklander Ziekenhuis

The Effects of Surgical Wait Time on Function, Pain and Health Related Quality of Life in Patients Awaiting Knee Arthroplasty: a Prospective Multicenter Cohort Study

This study prospectively evaluates the effect of surgical wait time on knee function, pain and quality of life in patients waiting for knee arthroplasty (TKA or PKA)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis (OA) is a common condition, leading to pain and disability. The knee is the most affected joint, accounting for almost 80 percent of the total prevalence of OA. The pooled global prevalence of knee OA is 22.9% in individuals aged 40 and over. Correspondingly, there are around 654.1 million individuals with knee OA in 2020 worldwide. The number of people affected with symptomatic knee OA is likely to increase because of the aging population and the obesity epidemic.

Pain is the most important symptom in knee OA. It is intermittent, typically weight bearing and progressive over time. Additional symptoms are crepitus, swelling and morning stiffness. The knee is often swollen and has diminished range of motion (ROM). Not only does OA lead to functional disability, but also influences social participation and quality of life.

Knee OA is a progressive disease, which requires continuous management. Treatment consists of conservative as well as invasive treatments, as described in national and international guidelines. First line treatments are patient education, physical therapy, weight loss, different pharmacological treatments and intra-articular steroid injections. More advanced OA may require surgery. Knee arthroplasty, (total knee arthroplasty (TKA) or partial knee arthroplasty (PKA)) can provide excellent pain relief, remarkable deformity correction, and satisfactory functional recovery.

Since the beginning of the covid19 pandemic, surgeons have been asked to only perform essential surgeries in order to preserve healthcare resources. This has led to an increase in patients on the waiting list, resulting in unusually high wait times. Despite the decrease in covid related healthcare consumption, waiting times are yet to return to pre-covid duration. Currently, time to surgery in our hospital is approximately 7 months as opposed to 2-3 months pre-covid.

Long wait times may be a substantial burden for patients. There have been reports of worsening pain, deterioration in quality of life and increased opioid use and frailty. The effects on pain catastrophizing, fear and anxiety have not yet been studied.

It is important to better understand the effects of long surgical wait times on pre-operative knee function, pain and quality of life as well as to investigate how this effects outcome after surgery.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Noord-Holland
      • Hoorn, Noord-Holland, Netherlands, 1624NP
        • Recruiting
        • Dijklander hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population consists of adult patients on the waiting list for knee arthroplasty (TKA or PKA).

Description

Inclusion Criteria:

  • on the waiting list for partial or total knee arthroplasty
  • written informed consent

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient on the waiting list for knee arthroplasty
adult patient on the waiting list for knee arthroplasty
Other: questionnaires
before surgery, patients are asked to fill out the questionnaires as stated in the outcome measures paragraph

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee function measured with the Oxford knee score (OKS)
Time Frame: Baseline, before surgery
This questionnaire consists of 12 items, which are divided into disease-specific and generic questions. Scores can range from 0 - 48, lower scores indicate more functional limitations and pain.
Baseline, before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numeric rating scale for pain (NRS)
Time Frame: baseline, before surgery, 6 and 12 months postoperatively
This scale consists of 11 numbers from 0-10, where 0 means no pain at all and 10 is the most pain imaginable. The patient should circle the number that best represents the severity of pain experienced over the past week
baseline, before surgery, 6 and 12 months postoperatively
Health related quality of life with the euroqol 5 dimensions (EQ-5D-5L)
Time Frame: baseline, before surgery, 6 and 12 months postoperatively
The EQ-5D is a questionnaire that scores five health dimensions (mobility, self-care, daily activities, pain/discomfort and anxiety/depression). Patient must indicate their health status: no problems, slight problems, moderate problems, severe problems, extreme problems.
baseline, before surgery, 6 and 12 months postoperatively
Hospital anxiety and depression scale (HADS)
Time Frame: baseline, before surgery, 6 and 12 months postoperatively
This is a short questionnaire that is easy to use. The scale examines feelings in the past week and consists of an anxiety scale and a depression scale with both 7 items. The higher a patient scores on this questionnaire, the more complaints one experiences.
baseline, before surgery, 6 and 12 months postoperatively
Pain catastrophizing scale (PCS)
Time Frame: baseline, before surgery, 6 and 12 months postoperatively
This self-assessment questionnaire consists of 13 statements that contain a number of thoughts and feelings that one may experience having pain. The items are divided into the categories rumination, magnification and helplessness, with each item scored on a 5-point scale. The sum of scores ranges from 0 - 52, with higher scores indicating higher levels of catastrophizing.
baseline, before surgery, 6 and 12 months postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
medical consumption questionnaire (iMCQ)
Time Frame: before surgery
The iMCQ includes questions related to frequently occurring contacts with health care providers. Reference is made to healthcare consumption due to illness, disability or psychiatric problems, without specifying a particular disease. Healthcare consumption in the preceding 13 weeks is applicable.
before surgery
Knee function measured with the Oxford knee score (OKS)
Time Frame: 6 and 12 months postoperatively
This questionnaire consists of 12 items, which are divided into disease-specific and generic questions. Scores can range from 0 - 48, lower scores indicate more functional limitations and pain.
6 and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dijklander Ziekenhuis

Investigators

  • Study Director: Gezina TM Oei, dr, Department of anesthesiology Dijklander Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC 23-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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