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| Name | Class |
|---|---|
| University of Exeter | OTHER |
| Nuffield Orthopaedic Centre NHS Trust | OTHER |
| Nottingham University Hospitals NHS Trust | OTHER |
| Wrightington, Wigan and Leigh NHS Foundation Trust |
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Following a prosthetic knee joint infection, two types of operative approach can be undertaken to treat the infection: a one-stage or two-stage revision operation. Both approaches are widely used and are good at treating infection but we don't know which has the best long-term outcomes for patients. This trial aims to assess the feasibility of conducting a randomised controlled trial to evaluate whether treating a prosthetic knee infection with one-stage revision surgery gives a better outcome than two-stage revision surgery in terms of patient function and pain, and cost-effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-stage | Active Comparator |
| |
| Two-stage | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-stage | Procedure | A one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately. |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of recruitment of participants | Number of recruits compared to the number of potential participants. | 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Explaining the study | Assessment of the process of explaining the study (explanation/recruitment/randomisation) between patients and surgeons via qualitative analysis of audio recording of pre-operative discussions about entering the study. | 20 months |
| Reasons for non-participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Toms, FRCS | Royal Devon and Exeter NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter NHS Trust (RD&E NHSFT) | Exeter | Devon | EX2 5DW | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40241215 | Derived | Terry R, Dean S, Hourigan P, Waterson HB, Wylde V, Carpenter N, Whale B, Powell RJ, Tarrant P, Medina-Lara A, Alvand A, Toms AD. MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection. Pilot Feasibility Stud. 2025 Apr 16;11(1):49. doi: 10.1186/s40814-025-01634-4. |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D007239 | Infections |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| OTHER |
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Blinding of participants and trial personnel will not be possible due to the nature of the intervention
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| Two-stage | Procedure | A two-stage revision operation involves two operations: the joint is removed in one operation, a temporary spacer device is inserted, then the infection is treated with antibiotics, and then a new joint is implanted in a second operation. |
|
Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial. |
| 20 months |
| Patient experience | Experience and acceptability of the process of recruitment, randomisation and study participation via qualitative analysis of semi-structured interview. | 2 weeks after surgery |
| Surgeon experience | Experience of the process of recruitment, randomisation and study participation including thoughts about trial design via qualitative analysis of semi-structured interview after each patient surgery and at the end of the trial. | 20 months |
| Protocol adherence | Assessment of any deviations or violations to protocol that occur during the trial. | 20 months |
| Healthcare resource utilisation | Patient-reported questionnaire assessing heath and social resource use through an adapted questionnaire of the Client Service Receipt Inventory (CSRI) at 3 and 6 months post-operatively | 20 months |
| Comparison of two sites | Recruitment and attrition rates at the two sites | 20 months |
| Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates | Patient-reported questionnaire assessing short-term and long-term symptoms and function in patients with knee injury to be administered pre-, 3 months and 6 months post-operatively | 20 months |
| Oxford Knee Score (OKS) outcome and completion rates | Patient-reported questionnaire assessing function and pain after total knee replacement surgery to be administered pre-, 3 months and 6 months post-operatively | 20 months |
| EQ-5D-5L outcome and completion rates | Patient-reported questionnaire assessing health-related quality of life to be administered pre-, 3 months and 6 months post-operatively | 20 months |
| Nuffiels Orthopaedic Centre (NOC) |
| Oxford |
| United Kingdom |