MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

Arthroplasty, Replacement, Knee Clinical Trial

— MIKROBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04458961
• Other study ID #: 272334
• Status: Completed
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: January 30, 2023

Study information

• Verified date: November 2023
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter NHS Trust (RD&E NHSFT)	Exeter	Devon
United Kingdom	Nuffiels Orthopaedic Centre (NOC)	Oxford

Sponsors (5)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	Nottingham University Hospitals NHS Trust, Nuffield Orthopaedic Centre NHS Trust, University of Exeter, Wrightington, Wigan and Leigh NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of recruitment of participants	Number of recruits compared to the number of potential participants.	20 months
Secondary	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
Secondary	Reasons for non-participation	Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial.	20 months
Secondary	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
Secondary	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
Secondary	Protocol adherence	Assessment of any deviations or violations to protocol that occur during the trial.	20 months
Secondary	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
Secondary	Comparison of two sites	Recruitment and attrition rates at the two sites	20 months
Secondary	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
Secondary	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
Secondary	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