Knee OsteoarthritisSIT'NWAITNCT06127719
The Effects of Surgical Wait Time for Knee Arthroplasty Quality of Life in Patients Awaiting Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Dijklander Ziekenhuis at 1 site in Netherlands.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- questionnaires
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients on the waiting list for knee arthroplasty (TKA or PKA).
Who may be able to join
- on the waiting list for partial or total knee arthroplasty
- written informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Dijklander Hospital
Hoorn, North Holland, 1624NP
About this study
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
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)
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- questionnaires
- Keywords
- knee arthroplasty, surgical waiting time, waiting list, knee pain, total knee arthroplasy, partial knee arthroplasty, knee function, quality of life, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
before surgery, patients are asked to fill out the questionnaires as stated in the outcome measures paragraph
| Study group | Role | What they receive |
|---|---|---|
| patient on the waiting list for knee arthroplasty | adult patient on the waiting list for knee arthroplasty Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee function measured with the Oxford knee score (OKS)
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.
Measured: Baseline, before surgery
Secondary outcomes (4)
numeric rating scale for pain (NRS)
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
Measured: baseline, before surgery, 6 and 12 months postoperatively
Health related quality of life with the euroqol 5 dimensions (EQ-5D-5L)
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.
Measured: baseline, before surgery, 6 and 12 months postoperatively
Hospital anxiety and depression scale (HADS)
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.
Measured: baseline, before surgery, 6 and 12 months postoperatively
Pain catastrophizing scale (PCS)
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.
Measured: baseline, before surgery, 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dijklander Ziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gezina TM Oei, dr, Study director, Department of anesthesiology Dijklander Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127719
- Sponsor's protocol ID
- DOC 23-023
- Acronym
- SIT'NWAIT
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.
PubMed 34505846Bertrix L, Lakhal M, Timour Chah Q, Lang J, Foussat C, Faucon G. [Caudal anesthesia by lidocaine in children. Diffusion in the blood and possible cardiac effects]. Therapie. 1985 Jul-Aug;40(4):225-9. No abstract available. French.
PubMed 4024017Bunt CW, Jonas CE, Chang JG. Knee Pain in Adults and Adolescents: The Initial Evaluation. Am Fam Physician. 2018 Nov 1;98(9):576-585.
PubMed 30325638Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
PubMed 31034380Bruyere O, Honvo G, Veronese N, Arden NK, Branco J, Curtis EM, Al-Daghri NM, Herrero-Beaumont G, Martel-Pelletier J, Pelletier JP, Rannou F, Rizzoli R, Roth R, Uebelhart D, Cooper C, Reginster JY. An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Semin Arthritis Rheum. 2019 Dec;49(3):337-350. doi: 10.1016/j.semarthrit.2019.04.008. Epub 2019 Apr 30.
PubMed 31126594Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
PubMed 31278997van Geene AR, Saris DB, Custers RJ. [Pain following primary total knee replacement: causes, diagnosis and treatment]. Ned Tijdschr Geneeskd. 2015;159:A8445. Dutch.
PubMed 26395566Bedard NA, Elkins JM, Brown TS. Effect of COVID-19 on Hip and Knee Arthroplasty Surgical Volume in the United States. J Arthroplasty. 2020 Jul;35(7S):S45-S48. doi: 10.1016/j.arth.2020.04.060. Epub 2020 Apr 24.
PubMed 32381441Clement ND, Scott CEH, Murray JRD, Howie CR, Deehan DJ; IMPACT-Restart Collaboration. The number of patients "worse than death" while waiting for a hip or knee arthroplasty has nearly doubled during the COVID-19 pandemic. Bone Joint J. 2021 Apr;103-B(4):672-680. doi: 10.1302/0301-620X.103B.BJJ-2021-0104.R1. Epub 2021 Mar 23.
PubMed 33752468Clement ND, Wickramasinghe NR, Bayram JM, Hughes K, Oag E, Heinz N, Fraser E, Jefferies JG, Dall GF, Ballantyne A, Jenkins PJ. Significant deterioration in quality of life and increased frailty in patients waiting more than six months for total hip or knee arthroplasty : a cross-sectional multicentre study. Bone Joint J. 2022 Nov;104-B(11):1215-1224. doi: 10.1302/0301-620X.104B11.BJJ-2022-0470.R2.
PubMed 36317352Farrow L, Gardner WT, Tang CC, Low R, Forget P, Ashcroft GP. Impact of COVID-19 on opioid use in those awaiting hip and knee arthroplasty: a retrospective cohort study. BMJ Qual Saf. 2023 Aug;32(8):479-484. doi: 10.1136/bmjqs-2021-013450. Epub 2021 Sep 14.
PubMed 34521769Henry EB, Barry LE, Hobbins AP, McClure NS, O'Neill C. Estimation of an Instrument-Defined Minimally Important Difference in EQ-5D-5L Index Scores Based on Scoring Algorithms Derived Using the EQ-VT Version 2 Valuation Protocols. Value Health. 2020 Jul;23(7):936-944. doi: 10.1016/j.jval.2020.03.003. Epub 2020 May 14.
PubMed 32762996
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06127719
- Acronym / sponsor ID
- SIT'NWAIT / DOC 23-023
- Conditions
- Knee Osteoarthritis
- Keywords
- knee arthroplasty, surgical waiting time, waiting list, knee pain, total knee arthroplasy, partial knee arthroplasty, knee function, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dijklander ZiekenhuisUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient on the waiting list for knee arthroplasty | – | Other: questionnairesadult patient on the waiting list for knee arthroplasty |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients on the waiting list for knee arthroplasty (TKA or PKA).
Key inclusion criteria (2 listed)
- on the waiting list for partial or total knee arthroplasty
- written informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesbefore surgery, patients are asked to fill out the questionnaires as stated in the outcome measures paragraph | Other | patient on the waiting list for knee arthroplasty |
Primary outcome
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.
4 secondary outcomes
numeric rating scale for pain (NRS)
Time frame: 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
Hospital anxiety and depression scale (HADS)
Time frame: baseline, before surgery, 6 and 12 months postoperatively
Pain catastrophizing scale (PCS)
Time frame: baseline, before surgery, 6 and 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Background: PubMed 34505846Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.
- Background: PubMed 4024017Bertrix L, Lakhal M, Timour Chah Q, Lang J, Foussat C, Faucon G. [Caudal anesthesia by lidocaine in children. Diffusion in the blood and possible cardiac effects]. Therapie. 1985 Jul-Aug;40(4):225-9. No abstract available. French.
- Background: PubMed 30325638Bunt CW, Jonas CE, Chang JG. Knee Pain in Adults and Adolescents: The Initial Evaluation. Am Fam Physician. 2018 Nov 1;98(9):576-585.
- Background: PubMed 31034380Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
- Background: PubMed 31126594Bruyere O, Honvo G, Veronese N, Arden NK, Branco J, Curtis EM, Al-Daghri NM, Herrero-Beaumont G, Martel-Pelletier J, Pelletier JP, Rannou F, Rizzoli R, Roth R, Uebelhart D, Cooper C, Reginster JY. An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Semin Arthritis Rheum. 2019 Dec;49(3):337-350. doi: 10.1016/j.semarthrit.2019.04.008. Epub 2019 Apr 30.
- Background: PubMed 31278997Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
- Background: PubMed 26395566van Geene AR, Saris DB, Custers RJ. [Pain following primary total knee replacement: causes, diagnosis and treatment]. Ned Tijdschr Geneeskd. 2015;159:A8445. Dutch.
- Background: PubMed 32381441Bedard NA, Elkins JM, Brown TS. Effect of COVID-19 on Hip and Knee Arthroplasty Surgical Volume in the United States. J Arthroplasty. 2020 Jul;35(7S):S45-S48. doi: 10.1016/j.arth.2020.04.060. Epub 2020 Apr 24.
- Background: PubMed 33752468Clement ND, Scott CEH, Murray JRD, Howie CR, Deehan DJ; IMPACT-Restart Collaboration. The number of patients "worse than death" while waiting for a hip or knee arthroplasty has nearly doubled during the COVID-19 pandemic. Bone Joint J. 2021 Apr;103-B(4):672-680. doi: 10.1302/0301-620X.103B.BJJ-2021-0104.R1. Epub 2021 Mar 23.
- Background: PubMed 36317352Clement ND, Wickramasinghe NR, Bayram JM, Hughes K, Oag E, Heinz N, Fraser E, Jefferies JG, Dall GF, Ballantyne A, Jenkins PJ. Significant deterioration in quality of life and increased frailty in patients waiting more than six months for total hip or knee arthroplasty : a cross-sectional multicentre study. Bone Joint J. 2022 Nov;104-B(11):1215-1224. doi: 10.1302/0301-620X.104B11.BJJ-2022-0470.R2.
- Background: PubMed 34521769Farrow L, Gardner WT, Tang CC, Low R, Forget P, Ashcroft GP. Impact of COVID-19 on opioid use in those awaiting hip and knee arthroplasty: a retrospective cohort study. BMJ Qual Saf. 2023 Aug;32(8):479-484. doi: 10.1136/bmjqs-2021-013450. Epub 2021 Sep 14.
- Background: PubMed 32762996Henry EB, Barry LE, Hobbins AP, McClure NS, O'Neill C. Estimation of an Instrument-Defined Minimally Important Difference in EQ-5D-5L Index Scores Based on Scoring Algorithms Derived Using the EQ-VT Version 2 Valuation Protocols. Value Health. 2020 Jul;23(7):936-944. doi: 10.1016/j.jval.2020.03.003. Epub 2020 May 14.
- Dutch national guideline for knee arthroplastyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gezina TM Oei, dr study director
Department of anesthesiology Dijklander Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Dijklander Ziekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rienk van Beek, drs (+31229257257, r.vanbeek@dijklander.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee function measured with the Oxford knee score (OKS) (time frame: Baseline, before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127719, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.