MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection
Abstract Background Total knee replacement surgery is common, with over 107,000 operations performed in the UK in 2019. After surgery, about 1% of patients develop a deep infection, known as a prosthetic joint infection. Two types of operations, one- or two-stage revision surgery, are routinely perf...
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| Language: | English |
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BMC
2025-04-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-025-01634-4 |
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| author | Rohini Terry Sarah Dean Patrick Hourigan Hugh Ben Waterson Vikki Wylde Natalie Carpenter Bethany Whale Roy J. Powell Polly Tarrant Antonieta Medina-Lara Abtin Alvand Andrew D. Toms |
| author_facet | Rohini Terry Sarah Dean Patrick Hourigan Hugh Ben Waterson Vikki Wylde Natalie Carpenter Bethany Whale Roy J. Powell Polly Tarrant Antonieta Medina-Lara Abtin Alvand Andrew D. Toms |
| author_sort | Rohini Terry |
| collection | DOAJ |
| description | Abstract Background Total knee replacement surgery is common, with over 107,000 operations performed in the UK in 2019. After surgery, about 1% of patients develop a deep infection, known as a prosthetic joint infection. Two types of operations, one- or two-stage revision surgery, are routinely performed to treat the infection. Re-infection rates are similar, but there is uncertainty regarding longer-term outcomes for patients. The aim of this study was to establish the feasibility of conducting a future randomised controlled trial that will compare clinical and cost-effectiveness of one-stage versus two-stage revision knee surgery for prosthetic joint infection. Methods Following eligibility screening, consenting patients took part in an audio-recorded consultation with their surgeon and were then randomised on a 1:1 allocation to one-stage or two-stage revision surgery. Patient-reported outcome measures were administered at baseline and 3 and 6 months postoperatively. Embedded qualitative work with patient participants and nonparticipants and with surgeons to understand the acceptability of trial processes and involvement was undertaken. Patient and public involvement and engagement activities were conducted throughout the study. Results Of 136 patients screened, only 3 were randomised and had surgery as part of the study. Qualitative data were collected from the three participants, as well as from two eligible patients who declined participation and two who withdrew from participation after the initial patient-surgeon consultation. Five surgeons took part in qualitative interviews prior to study end. Conclusion This study indicated that a larger randomised controlled trial evaluating one-stage versus two-stage revision knee surgery for prosthetic joint infection is not feasible with the current straightforward randomised controlled trial design. Future research needs to consider the most appropriate study design and methodology to address this important research question. Trial registration No.: NCT04458961. |
| format | Article |
| id | doaj-art-e0565ee7830e438c8fa6744035fdbd72 |
| institution | DOAJ |
| issn | 2055-5784 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj-art-e0565ee7830e438c8fa6744035fdbd722025-08-20T03:18:27ZengBMCPilot and Feasibility Studies2055-57842025-04-0111111410.1186/s40814-025-01634-4MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infectionRohini Terry0Sarah Dean1Patrick Hourigan2Hugh Ben Waterson3Vikki Wylde4Natalie Carpenter5Bethany Whale6Roy J. Powell7Polly Tarrant8Antonieta Medina-Lara9Abtin Alvand10Andrew D. Toms11University of Exeter Medical School, St Luke’S CampusUniversity of Exeter Medical School, St Luke’S CampusExeter Knee Reconstruction Unit, Princess Elizabeth Orthopaedic Centre, Royal Devon University Hospital NHS TrustExeter Knee Reconstruction Unit, Princess Elizabeth Orthopaedic Centre, Royal Devon University Hospital NHS TrustMusculoskeletal Research Unit, NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Medical School, University of BristolUniversity of Exeter Medical School, St Luke’S CampusUniversity of Exeter Medical School, St Luke’S CampusNIHR Research Design Service South WestExeter Knee Reconstruction Unit, Princess Elizabeth Orthopaedic Centre, Royal Devon University Hospital NHS TrustUniversity of Exeter Medical School, St Luke’S CampusNuffield Department of Orthopaedics (NOC), University of OxfordExeter Knee Reconstruction Unit, Princess Elizabeth Orthopaedic Centre, Royal Devon University Hospital NHS TrustAbstract Background Total knee replacement surgery is common, with over 107,000 operations performed in the UK in 2019. After surgery, about 1% of patients develop a deep infection, known as a prosthetic joint infection. Two types of operations, one- or two-stage revision surgery, are routinely performed to treat the infection. Re-infection rates are similar, but there is uncertainty regarding longer-term outcomes for patients. The aim of this study was to establish the feasibility of conducting a future randomised controlled trial that will compare clinical and cost-effectiveness of one-stage versus two-stage revision knee surgery for prosthetic joint infection. Methods Following eligibility screening, consenting patients took part in an audio-recorded consultation with their surgeon and were then randomised on a 1:1 allocation to one-stage or two-stage revision surgery. Patient-reported outcome measures were administered at baseline and 3 and 6 months postoperatively. Embedded qualitative work with patient participants and nonparticipants and with surgeons to understand the acceptability of trial processes and involvement was undertaken. Patient and public involvement and engagement activities were conducted throughout the study. Results Of 136 patients screened, only 3 were randomised and had surgery as part of the study. Qualitative data were collected from the three participants, as well as from two eligible patients who declined participation and two who withdrew from participation after the initial patient-surgeon consultation. Five surgeons took part in qualitative interviews prior to study end. Conclusion This study indicated that a larger randomised controlled trial evaluating one-stage versus two-stage revision knee surgery for prosthetic joint infection is not feasible with the current straightforward randomised controlled trial design. Future research needs to consider the most appropriate study design and methodology to address this important research question. Trial registration No.: NCT04458961.https://doi.org/10.1186/s40814-025-01634-4Total knee replacementProsthetic joint infectionOrthopaedic surgeryFeasibilityEquipoiseRecruitment |
| spellingShingle | Rohini Terry Sarah Dean Patrick Hourigan Hugh Ben Waterson Vikki Wylde Natalie Carpenter Bethany Whale Roy J. Powell Polly Tarrant Antonieta Medina-Lara Abtin Alvand Andrew D. Toms MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection Pilot and Feasibility Studies Total knee replacement Prosthetic joint infection Orthopaedic surgery Feasibility Equipoise Recruitment |
| title | MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection |
| title_full | MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection |
| title_fullStr | MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection |
| title_full_unstemmed | MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection |
| title_short | MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection |
| title_sort | mikrobe a feasibility study for a randomised controlled trial of one stage or two stage surgery for prosthetic knee infection |
| topic | Total knee replacement Prosthetic joint infection Orthopaedic surgery Feasibility Equipoise Recruitment |
| url | https://doi.org/10.1186/s40814-025-01634-4 |
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