NCT05380648

Brief Summary

Osteoarthritis (OA) is the main cause of pain and disability in elderly. For knee OA, a total knee replacement (TKR) is an effective surgical treatment, and the majority of patients report substantial pain relief and functional improvement following surgery. However, 20-40% of patients undergoing TKR are dissatisfied with postsurgical outcome. Even after revision, some patients keep complaining of persisting pain. In this study, the investigators will examine putative prognostic factors on the basis of the biopsychosocial model. Besides several psychological factors (measured with questionnaires), the investigators will assess structural impairments (such as radiographic severity of OA), functional impairments (muscle weakness and proprioceptive deficits), anesthetic procedures, immediate postoperative pain management, metabolic factors (body composition and hemoglobin A1c), inflammatory factors (C-Reactive Protein) and the investigators also will examine the role of altered central pain processing (CPP) (primary and secondary mechanical hyperalgesia, mechanical temporal summation, thermal primary and secondary hyperalgesia, endogenous pain modulation). With a longitudinal study design, this study will explore which factors are predictive of poor outcome in knee OA patients after TKR. Moreover, the interrelationship between CPP, structural, functional, metabolic, inflammatory and psychological factors, and the clinical expression of knee OA (pain, symptoms, physical performance and quality of life) will be investigated. Further research on the role of the aforementioned putative prognostic factors on postsurgical outcome could contribute to better management of these patients, since these factors may be particularly important for patient-tailored treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

5.4 years

First QC Date

April 29, 2021

Last Update Submit

December 21, 2023

Conditions

Osteoarthritis, KneeArthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (6)

  • Pain intensity

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

    Change from baseline pain intensity at 3 months postoperative

  • Pain intensity

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

    Change from baseline pain intensity at 1 year postoperative

  • Pain intensity

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

    Change from 3 months postoperative at 1 year postoperative

  • Pain intensity

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

    Baseline (preoperative)

  • Pain intensity

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

    3 months postoperative

  • Pain intensity

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

    1 year postoperative

Secondary Outcomes (139)

  • Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Change from baseline (preoperative) to 3 months postoperative

  • Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Change from baseline (preoperative) to 1 year postoperative

  • Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Change from 3 months postoperative to 1 year postoperative

  • Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Baseline (preoperative)

  • Central pain processing: mechanical local and widespread hyperalgesia allodynia

    3 months postoperative

  • +134 more secondary outcomes

Interventions

Total knee arthroplastyPROCEDURE

Total knee arthroplasty surgery will be performed by different orthopedist.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Knee OA patients awaiting primary TKR surgery will be recruited at the University Hospital of Antwerp (BE), AZ Monica (BE), the academic hospital of Maastricht (NL) and St Jans Gasthuis Weert (NL). In each hospital, at least one orthopaedic surgeon already agreed to participate in this study and to recruit patients.

You may qualify if:

  • Knee OA patients \>40 years awaiting TKR surgery. Both men and women of all ethnical backgrounds are included.

You may not qualify if:

  • Patients with diagnosis of neurological/ systemic diseases, possibly impacting pain
  • Patients who are not capable of understanding and speaking Dutch
  • Revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Antwerp

Antwerp, 2610, Belgium

Location

Related Publications (3)

  • Vervullens S, Meert L, Smeets RJEM, van der Nest G, Verbrugghe J, Verdonk P, Rahusen FTG, Meeus M. A biopsychosocial approach to phenotyping people with knee osteoarthritis awaiting total knee arthroplasty: A secondary cohort analysis. Ann Phys Rehabil Med. 2024 Nov;67(8):101895. doi: 10.1016/j.rehab.2024.101895. Epub 2024 Oct 28.

    PMID: 39489935DERIVED

  • Vervullens S, Meert L, Smeets RJEM, Verbrugghe J, Baert I, Rahusen FTG, Heusdens CHW, Verdonk P, Meeus M. Preoperative glycaemic control, number of pain locations, structural knee damage, self-reported central sensitisation, satisfaction and personal control are predictive of 1-year postoperative pain, and change in pain from pre- to 1-year posttotal knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2025 Jan;33(1):201-219. doi: 10.1002/ksa.12265. Epub 2024 May 15.

    PMID: 38751081DERIVED

  • Vervullens S, Meert L, Smeets RJEM, Verbrugghe J, Verdonk P, Meeus M. Does pain intensity after total knee arthroplasty depend on somatosensory functioning in knee osteoarthritis patients? A prospective cohort study. Clin Rheumatol. 2024 Jun;43(6):2047-2059. doi: 10.1007/s10067-024-06976-7. Epub 2024 Apr 26.

    PMID: 38668988DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Sophie Vervullens

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

  • Lotte Meert

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

  • Mira Meeus

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

  • Isabel Baert

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

  • Rob J.E.M. Smeets

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral student Sophie Vervullens

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 19, 2022

Study Start

March 8, 2018

Primary Completion

July 14, 2023

Study Completion

July 14, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations

BE(1)