MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

Study Overview
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Brief Summary
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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.

Official Title
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MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence A Feasibility Study for a Randomised Controlled Trial of One-stage or Two-stage Surgery for Prosthetic Knee Infection

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Procedure: One-stage
* Procedure: Two-stage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with prosthetic knee infection suitable for either one-stage or two-stage revision surgery Intra-operatively, all cases must have adequate soft-tissue coverage post debridement to allow single or two stage revision surgery. Case meets the International Consensus Meeting criteria for infection Patients having had a Debridement, Anti-biotic and Implant Retained procedure previously or washout/biopsy only of an infected TKR are suitable Exclusion Criteria: Unable or unwilling to undergo either treatment Lacking capacity to consent to research Refusal to consent to study for any reason Re-revision of prosthetic knee infection if first revision was for infection Presence of tuberculosis infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One-stage<br> | Procedure: One-stage<br>* A one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately.<br>|
| Active Comparator: Two-stage<br> | Procedure: Two-stage<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of recruitment of participants | Number of recruits compared to the number of potential participants. | 20 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthropathy, Arthropathy Related to Infection, Arthropathy of Knee Joint, One-stage, Two-stage, Infection, Prosthetic joint infection