Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial
Abstract Introduction Knee osteoarthritis is a common disease with pain as the most prevalent symptom. Previous cohort studies have shown genicular artery embolization to reduce pain symptoms in patients with mild to moderate knee osteoarthritis. Patients resistant to conservative therapy but not el...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-01-01
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| Series: | Trials |
| Online Access: | https://doi.org/10.1186/s13063-021-05942-x |
| _version_ | 1798034719892307968 |
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| author | T. A. van Zadelhoff A. Moelker S. M. A. Bierma-Zeinstra P. K. Bos G. P. Krestin E. H. G. Oei |
| author_facet | T. A. van Zadelhoff A. Moelker S. M. A. Bierma-Zeinstra P. K. Bos G. P. Krestin E. H. G. Oei |
| author_sort | T. A. van Zadelhoff |
| collection | DOAJ |
| description | Abstract Introduction Knee osteoarthritis is a common disease with pain as the most prevalent symptom. Previous cohort studies have shown genicular artery embolization to reduce pain symptoms in patients with mild to moderate knee osteoarthritis. Patients resistant to conservative therapy but not eligible yet for surgical treatment due to young age or comorbidities may profit from an effective and sustained pain reduction treatment. This study is a randomized sham-controlled trial to evaluate the efficacy of genicular artery embolization in patients with knee osteoarthritis. Methods and analysis Fifty-eight patients with mild-to-moderate knee osteoarthritis will be recruited and randomly allocated to the treatment or control group in a 1:1 ratio. Participants in the treatment group will undergo genicular artery embolization. Patients in the control group will undergo sham treatment. Outcome measurements will be assessed at baseline and after 1, 4, 8, and 12 months with questionnaires, pressure pain threshold testing, and MR imaging. The MR imaging protocol is designed to (semi)quantitatively assess osteoarthritis in the knee joint. The primary outcome is the change from baseline of the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale after 4 months. Secondary outcomes include change in osteoarthritis-related questionnaires, pressure pain threshold, and OA-related MRI features, particularly synovitis and bone marrow lesions. Ethics and dissemination This trial will determine the efficacy of genicular artery embolization compared to a sham treatment. This is of importance to assess before proceeding to larger-scale efficiency studies and, ultimately, implementing this treatment into day to day clinical practice. Trial registration ClinicalTrials.gov NCT03884049. Registered on 21 March 2019 |
| first_indexed | 2024-04-11T20:48:10Z |
| format | Article |
| id | doaj.art-52bac4af5b034c0eb00cd2e8ac6b9cf6 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T20:48:10Z |
| publishDate | 2022-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-52bac4af5b034c0eb00cd2e8ac6b9cf62022-12-22T04:03:58ZengBMCTrials1745-62152022-01-012311810.1186/s13063-021-05942-xGenicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trialT. A. van Zadelhoff0A. Moelker1S. M. A. Bierma-Zeinstra2P. K. Bos3G. P. Krestin4E. H. G. Oei5Department of Radiology and Nuclear Medicine, Erasmus MC, University Medical Center RotterdamDepartment of Radiology and Nuclear Medicine, Erasmus MC, University Medical Center RotterdamDepartment of General Practice, Erasmus MC, University Medical Center RotterdamDepartment Orthopaedic surgery, Erasmus MC, University Medical Center RotterdamDepartment of Radiology and Nuclear Medicine, Erasmus MC, University Medical Center RotterdamDepartment of Radiology and Nuclear Medicine, Erasmus MC, University Medical Center RotterdamAbstract Introduction Knee osteoarthritis is a common disease with pain as the most prevalent symptom. Previous cohort studies have shown genicular artery embolization to reduce pain symptoms in patients with mild to moderate knee osteoarthritis. Patients resistant to conservative therapy but not eligible yet for surgical treatment due to young age or comorbidities may profit from an effective and sustained pain reduction treatment. This study is a randomized sham-controlled trial to evaluate the efficacy of genicular artery embolization in patients with knee osteoarthritis. Methods and analysis Fifty-eight patients with mild-to-moderate knee osteoarthritis will be recruited and randomly allocated to the treatment or control group in a 1:1 ratio. Participants in the treatment group will undergo genicular artery embolization. Patients in the control group will undergo sham treatment. Outcome measurements will be assessed at baseline and after 1, 4, 8, and 12 months with questionnaires, pressure pain threshold testing, and MR imaging. The MR imaging protocol is designed to (semi)quantitatively assess osteoarthritis in the knee joint. The primary outcome is the change from baseline of the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale after 4 months. Secondary outcomes include change in osteoarthritis-related questionnaires, pressure pain threshold, and OA-related MRI features, particularly synovitis and bone marrow lesions. Ethics and dissemination This trial will determine the efficacy of genicular artery embolization compared to a sham treatment. This is of importance to assess before proceeding to larger-scale efficiency studies and, ultimately, implementing this treatment into day to day clinical practice. Trial registration ClinicalTrials.gov NCT03884049. Registered on 21 March 2019https://doi.org/10.1186/s13063-021-05942-x |
| spellingShingle | T. A. van Zadelhoff A. Moelker S. M. A. Bierma-Zeinstra P. K. Bos G. P. Krestin E. H. G. Oei Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial Trials |
| title | Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial |
| title_full | Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial |
| title_fullStr | Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial |
| title_full_unstemmed | Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial |
| title_short | Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial |
| title_sort | genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis protocol design of a randomized sham controlled clinical trial |
| url | https://doi.org/10.1186/s13063-021-05942-x |
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