MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

Not Applicable

Completed

• Conditions: Arthroplasty, Replacement, Knee
• Interventions: Procedure: One-stage; Procedure: Two-stage

• Registration Number: NCT04458961
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-07
• Study Start: 2020-11-17
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One-stage	One-stage	-
Two-stage	Two-stage	-

Primary Outcome Measures

Name	Time	Method
Ease of recruitment of participants	20 months	Number of recruits compared to the number of potential participants.

Secondary Outcome Measures

Name	Time	Method
Comparison of two sites	20 months	Recruitment and attrition rates at the two sites
Explaining the study	20 months	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.
Surgeon experience	20 months	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.
Protocol adherence	20 months	Assessment of any deviations or violations to protocol that occur during the trial.
Reasons for non-participation	20 months	Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial.
Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates	20 months	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
Oxford Knee Score (OKS) outcome and completion rates	20 months	Patient-reported questionnaire assessing function and pain after total knee replacement surgery to be administered pre-, 3 months and 6 months post-operatively
EQ-5D-5L outcome and completion rates	20 months	Patient-reported questionnaire assessing health-related quality of life to be administered pre-, 3 months and 6 months post-operatively
Patient experience	2 weeks after surgery	Experience and acceptability of the process of recruitment, randomisation and study participation via qualitative analysis of semi-structured interview.
Healthcare resource utilisation	20 months	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

Trial Locations

Locations (2)

Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter NHS Trust (RD&E NHSFT); 🇬🇧 Exeter, Devon, United Kingdom

Nuffiels Orthopaedic Centre (NOC); 🇬🇧 Oxford, United Kingdom