Cargando…
Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial
BACKGROUND: Total knee arthroplasty (TKA) is an effective procedure for late-stage osteoarthritis (OA) of the knee; however, up to 20% of patients remain dissatisfied. In some patients, this may be due to residual inflammation of the synovium. Our aim was to perform the first randomised controlled t...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6109454/ https://www.ncbi.nlm.nih.gov/pubmed/30151238 http://dx.doi.org/10.1186/s40814-018-0336-y |
_version_ | 1783350324356972544 |
---|---|
author | Rankin, Kenneth S. Ramaskandhan, Jayasree Bardgett, Michelle Merrie, Katie Gangadharan, Rajkumar Wilson, Ian Deehan, David |
author_facet | Rankin, Kenneth S. Ramaskandhan, Jayasree Bardgett, Michelle Merrie, Katie Gangadharan, Rajkumar Wilson, Ian Deehan, David |
author_sort | Rankin, Kenneth S. |
collection | PubMed |
description | BACKGROUND: Total knee arthroplasty (TKA) is an effective procedure for late-stage osteoarthritis (OA) of the knee; however, up to 20% of patients remain dissatisfied. In some patients, this may be due to residual inflammation of the synovium. Our aim was to perform the first randomised controlled trial (RCT) of synovectomy during TKA for patients with macroscopically inflamed synovium. The main objectives were to assess recruitment rates, protocol adherence and outcomes relating to safety such as haemoglobin decrease and adverse events. We also collected data on patient-reported outcomes. METHODS: We performed a single-centre pilot RCT. Patients with a macroscopically inflamed synovium were randomised to receive synovectomy versus a control group that did not undergo synovectomy. We determined feasibility by measuring patient enrolment, completeness of follow-up, and safety via haemoglobin decrease and documentation of adverse events. RESULTS: We screened 360 patients with 260 deemed ineligible or could not be recruited. From the 100 eligible patients, 54 were enrolled and 40 progressed through to randomisation. All made it to the 12-month follow-up, indicating good protocol adherence. There were no major differences in adverse events or haemoglobin decrease demonstrating acceptable safety. Outcomes relating to satisfaction were reliably obtained. CONCLUSIONS: Patients with macroscopically inflamed synovium of the knee who are due to undergo TKA can be reliably recruited to a randomised trial and synovectomy can be performed safely. A large number is needed to be screened to identify eligible participants, and therefore, a multi-centre trial would be required to assess whether routine synovectomy would improve outcomes in these patients. TRIAL REGISTRATION: ISRCTN, ISRCTN31010214. Registered 6 October 2016—retrospectively registered ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-018-0336-y) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6109454 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-61094542018-08-27 Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial Rankin, Kenneth S. Ramaskandhan, Jayasree Bardgett, Michelle Merrie, Katie Gangadharan, Rajkumar Wilson, Ian Deehan, David Pilot Feasibility Stud Research BACKGROUND: Total knee arthroplasty (TKA) is an effective procedure for late-stage osteoarthritis (OA) of the knee; however, up to 20% of patients remain dissatisfied. In some patients, this may be due to residual inflammation of the synovium. Our aim was to perform the first randomised controlled trial (RCT) of synovectomy during TKA for patients with macroscopically inflamed synovium. The main objectives were to assess recruitment rates, protocol adherence and outcomes relating to safety such as haemoglobin decrease and adverse events. We also collected data on patient-reported outcomes. METHODS: We performed a single-centre pilot RCT. Patients with a macroscopically inflamed synovium were randomised to receive synovectomy versus a control group that did not undergo synovectomy. We determined feasibility by measuring patient enrolment, completeness of follow-up, and safety via haemoglobin decrease and documentation of adverse events. RESULTS: We screened 360 patients with 260 deemed ineligible or could not be recruited. From the 100 eligible patients, 54 were enrolled and 40 progressed through to randomisation. All made it to the 12-month follow-up, indicating good protocol adherence. There were no major differences in adverse events or haemoglobin decrease demonstrating acceptable safety. Outcomes relating to satisfaction were reliably obtained. CONCLUSIONS: Patients with macroscopically inflamed synovium of the knee who are due to undergo TKA can be reliably recruited to a randomised trial and synovectomy can be performed safely. A large number is needed to be screened to identify eligible participants, and therefore, a multi-centre trial would be required to assess whether routine synovectomy would improve outcomes in these patients. TRIAL REGISTRATION: ISRCTN, ISRCTN31010214. Registered 6 October 2016—retrospectively registered ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-018-0336-y) contains supplementary material, which is available to authorized users. BioMed Central 2018-08-25 /pmc/articles/PMC6109454/ /pubmed/30151238 http://dx.doi.org/10.1186/s40814-018-0336-y Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Rankin, Kenneth S. Ramaskandhan, Jayasree Bardgett, Michelle Merrie, Katie Gangadharan, Rajkumar Wilson, Ian Deehan, David Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial |
title | Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial |
title_full | Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial |
title_fullStr | Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial |
title_full_unstemmed | Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial |
title_short | Synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial |
title_sort | synovectomy during total knee arthroplasty: a pilot single-centre randomised controlled trial |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6109454/ https://www.ncbi.nlm.nih.gov/pubmed/30151238 http://dx.doi.org/10.1186/s40814-018-0336-y |
work_keys_str_mv | AT rankinkenneths synovectomyduringtotalkneearthroplastyapilotsinglecentrerandomisedcontrolledtrial AT ramaskandhanjayasree synovectomyduringtotalkneearthroplastyapilotsinglecentrerandomisedcontrolledtrial AT bardgettmichelle synovectomyduringtotalkneearthroplastyapilotsinglecentrerandomisedcontrolledtrial AT merriekatie synovectomyduringtotalkneearthroplastyapilotsinglecentrerandomisedcontrolledtrial AT gangadharanrajkumar synovectomyduringtotalkneearthroplastyapilotsinglecentrerandomisedcontrolledtrial AT wilsonian synovectomyduringtotalkneearthroplastyapilotsinglecentrerandomisedcontrolledtrial AT deehandavid synovectomyduringtotalkneearthroplastyapilotsinglecentrerandomisedcontrolledtrial |