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NCT05380648
Predicting Outcome of Total Knee Replacement Surgery in Patients With Knee Osteoarthritis
trial testing Total knee arthroplasty in Osteoarthritis, Knee in 223 participants. Completed in 14 July 2023.
14 July 2023
Quick facts
| Lead sponsor | Universiteit Antwerpen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 223 |
| Start date | 8 March 2018 |
| Primary completion | 14 July 2023 |
| Estimated completion | 14 July 2023 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Total knee arthroplasty — full drug profile →
Conditions studied
- Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
- Arthroplasty, Replacement, Knee — all drugs for Arthroplasty, Replacement, Knee →
Sponsor
Universiteit Antwerpen — full company profile →
Who can join
40 and older, any sex, with Osteoarthritis, Knee or Arthroplasty, Replacement, Knee. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Vervullens S, Meert L, Smeets RJEM, Verbrugghe J, et al · · 2025 · cited 7× · PMID 38751081 · DOI 10.1002/ksa.12265 -
Does pain intensity after total knee arthroplasty depend on somatosensory functioning in knee osteoarthritis patients? A prospective cohort study.
Vervullens S, Meert L, Smeets RJEM, Verbrugghe J, et al · · 2024 · cited 6× · PMID 38668988 · DOI 10.1007/s10067-024-06976-7 -
Unravelling relationships between obesity, diabetes, and factors related to somatosensory functioning in knee osteoarthritis patients.
Meert L, Vervullens S, Heusdens CHW, Smeets RJEM, et al · · 2024 · cited 5× · PMID 38913223 · DOI 10.1007/s10067-024-07022-2 -
A biopsychosocial approach to phenotyping people with knee osteoarthritis awaiting total knee arthroplasty: A secondary cohort analysis.
Vervullens S, Meert L, Smeets RJEM, van der Nest G, et al · · 2024 · cited 2× · PMID 39489935 · DOI 10.1016/j.rehab.2024.101895 -
Application of the IASP Grading System to Identify Underlying Pain Mechanisms in Patients With Knee Osteoarthritis: A Prospective Cohort Study.
Vervullens S, Meert L, Meeus M, Heusdens CHW, et al · · 2024 · cited 1× · PMID 39016267 · DOI 10.1097/ajp.0000000000001234
Verify or expand the search:
- PubMed search for NCT05380648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Total knee arthroplasty
Trials testing the same drug.
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- NCT07489963 — Functional Impact at 12 Months Post-op of Posterior Cruciate Ligament Conservation During Robotic-assisted Surgery (MAKO · NA · recruiting
- NCT06726993 — Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA · NA · not yet recruiting
- NCT06553118 — Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery · not yet recruiting
- NCT05965765 — Effection of Total Knee Arthroplasty on Knee Joint · NA · completed
Other recruiting trials for Osteoarthritis, Knee
Currently open trials in the same condition.
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Other Universiteit Antwerpen trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05380648 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universiteit Antwerpen
- Last refreshed: 29 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05380648.
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