Clinical trial NCT06127719: The Effects of Surgical Wait Time for Knee Arthroplasty Quality of Life in Patients Awaiting Knee Arthroplasty
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Keywords: knee arthroplasty
surgical waiting time
waiting list
knee pain
total knee arthroplasy
partial knee arthroplasty
knee function
quality of life
Osteoarthritis
Lead sponsor: Dijklander Ziekenhuis
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of adult patients on the waiting list for knee arthroplasty (TKA or PKA).

Brief summary: 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)

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Knee function measured with the Oxford knee score (OKS)
timeFrame: Baseline, before surgery
Secondary outcomes:
measure: numeric rating scale for pain (NRS)
timeFrame: baseline, before surgery, 6 and 12 months postoperatively
measure: Health related quality of life with the euroqol 5 dimensions (EQ-5D-5L)
timeFrame: baseline, before surgery, 6 and 12 months postoperatively
measure: Hospital anxiety and depression scale (HADS)
timeFrame: baseline, before surgery, 6 and 12 months postoperatively
measure: Pain catastrophizing scale (PCS)
timeFrame: baseline, before surgery, 6 and 12 months postoperatively
Other outcomes:
measure: medical consumption questionnaire (iMCQ)
timeFrame: before surgery
measure: Knee function measured with the Oxford knee score (OKS)
timeFrame: 6 and 12 months postoperatively
Locations:
city: Hoorn
country: Netherlands
facility: Dijklander Hospital
state: Noord-Holland
Study officials:
affiliation: Department of anesthesiology Dijklander Hospital
name: Gezina TM Oei, dr
role: STUDY_DIRECTOR
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