MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

Royal Devon and Exeter NHS Foundation Trust3 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arthroplasty, Replacement, Knee

Interventions

Two-stagePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Ease of recruitment of participants

Number of recruits compared to the number of potential participants.

Time frame: 20 months

Secondary Outcomes

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.

Time frame: 20 months

Reasons for non-participation

Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial.

Time frame: 20 months

Patient experience

Experience and acceptability of the process of recruitment, randomisation and study participation via qualitative analysis of semi-structured interview.

Time frame: 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.

Time frame: 20 months

Protocol adherence

Assessment of any deviations or violations to protocol that occur during the trial.

Time frame: 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

Time frame: 20 months

Comparison of two sites

Recruitment and attrition rates at the two sites

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 20 months