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

NCT06127719 | Recruiting

• 1 other identifier: DOC 23-023
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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)

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, before surgery

Secondary Outcomes (4)

• numeric rating scale for pain (NRS)

  baseline, before surgery, 6 and 12 months postoperatively

• Health related quality of life with the euroqol 5 dimensions (EQ-5D-5L)

  baseline, before surgery, 6 and 12 months postoperatively

• Hospital anxiety and depression scale (HADS)

  baseline, before surgery, 6 and 12 months postoperatively

• Pain catastrophizing scale (PCS)

  baseline, before surgery, 6 and 12 months postoperatively

Other Outcomes (2)

• medical consumption questionnaire (iMCQ)

  before surgery

• Knee function measured with the Oxford knee score (OKS)

  6 and 12 months postoperatively

Study Arms (1)

patient on the waiting list for knee arthroplasty

adult patient on the waiting list for knee arthroplasty

Other: questionnaires

Interventions

questionnaires OTHER

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

patient on the waiting list for knee arthroplasty

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Dijklander Ziekenhuis: lead

Study Sites (1)

Dijklander Hospital

Hoorn, North Holland, 1624NP, Netherlands

RECRUITING

Related Publications (12)

• 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.

  PMID: 34505846 BACKGROUND

• Bertrix 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.

  PMID: 4024017 BACKGROUND

• Bunt CW, Jonas CE, Chang JG. Knee Pain in Adults and Adolescents: The Initial Evaluation. Am Fam Physician. 2018 Nov 1;98(9):576-585.

  PMID: 30325638 BACKGROUND

• Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.

  PMID: 31034380 BACKGROUND

• Bruyere 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.

  PMID: 31126594 BACKGROUND

• Bannuru 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.

  PMID: 31278997 BACKGROUND

• van Geene AR, Saris DB, Custers RJ. [Pain following primary total knee replacement: causes, diagnosis and treatment]. Ned Tijdschr Geneeskd. 2015;159:A8445. Dutch.

  PMID: 26395566 BACKGROUND

• Bedard 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.

  PMID: 32381441 BACKGROUND

• Clement 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.

  PMID: 33752468 BACKGROUND

• Clement 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.

  PMID: 36317352 BACKGROUND

• Farrow 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.

  PMID: 34521769 BACKGROUND

• Henry 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.

  PMID: 32762996 BACKGROUND

Related Links

• Dutch national guideline for non-traumatic knee complaints
• Dutch national guideline for knee arthroplasty

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gezina TM Oei, dr

  Department of anesthesiology Dijklander Hospital

  STUDY DIRECTOR

Central Study Contacts

Rienk van Beek, drs

CONTACT

+31229257257; r.vanbeek@dijklander.nl

Monique GM Schokker

CONTACT

+31229855529; m.g.m.schokker@dijklander.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

NL (1)