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

Sponsor
Dijklander Ziekenhuis (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06127719
Collaborator
(none)
150
1
48
3.1

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaires

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 had 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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Knee function measured with the Oxford knee score (OKS) [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 Outcome Measures

  1. numeric rating scale for pain (NRS) [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 his/her pain experienced over the past week

  2. Health related quality of life with the euroqol 5 dimensions (EQ-5D-5L) [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). The patient must indicate how he experiences his health status: no problems, slight problems, moderate problems, severe problems, extreme problems.

  3. Hospital anxiety and depression scale (HADS) [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 he/she experiences.

  4. Pain catastrophizing scale (PCS) [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 Outcome Measures

  1. medical consumption questionnaire (iMCQ) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • on the waiting list for partial or total knee arthroplasty

  • written informed consent

Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dijklander Hospital Hoorn Noord-Holland Netherlands 1624NP

Sponsors and Collaborators

  • Dijklander Ziekenhuis

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Dijklander Ziekenhuis
ClinicalTrials.gov Identifier:
NCT06127719
Other Study ID Numbers:
  • DOC 23-023
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dijklander Ziekenhuis
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023