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NCT Number: NCT06127719

The Effects of Surgical Wait Time for Knee Arthroplasty Quality of Life in Patients Awaiting Knee Arthroplasty

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)

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dijklander Hospital

Hoorn, North Holland, 1624NP, Netherlands

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

questionnaires

Other

before surgery, patients are asked to fill out the questionnaires as stated in the outcome measures paragraph

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Monique GM Schokker

CONTACT

[email protected]

+31229855529

Rienk van Beek, drs

CONTACT

[email protected]

+31229257257

Sponsors and collaborators

Lead sponsor

Dijklander Ziekenhuis

Other

Registry information

Official study title

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

Acronym: SIT'NWAIT

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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