MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence (MIKROBE)

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Procedure: One-stage; Procedure: Two-stage

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom
    • Nuffiels Orthopaedic Centre (NOC)
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter NHS Trust (RD&E NHSFT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Royal Devon and Exeter NHS Foundation Trust
• Collaborators: Nottingham University Hospitals NHS Trust; University of Exeter; Wrightington, Wigan and Leigh NHS Foundation Trust; Nuffield Orthopaedic Centre NHS Trust
• Investigators: Principal Investigator: Andrew Toms, FRCS, Royal Devon and Exeter NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Infection; Arthropathy; Prosthetic joint infection; Arthropathy Related to Infection; Arthropathy of Knee Joint; One-stage; Two-stage
• Other Study ID Numbers: 272334

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No