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Completed

NCT Number: NCT04458961

MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee Infections Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

one-stage

Procedure

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

Procedure

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.

Primary outcomes

  1. Ease of recruitment of participants

    Time frame: 20 months

    Number of recruits compared to the number of potential participants.

Secondary outcomes

  1. Explaining the study

    Time frame: 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.

  2. Reasons for non-participation

    Time frame: 20 months

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

  3. Patient experience

    Time frame: 2 weeks after surgery

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

  4. Surgeon experience

    Time frame: 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.

  5. Protocol adherence

    Time frame: 20 months

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

  6. Healthcare resource utilisation

    Time frame: 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

  7. Comparison of two sites

    Time frame: 20 months

    Recruitment and attrition rates at the two sites

  8. Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates

    Time frame: 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

  9. Oxford Knee Score (OKS) outcome and completion rates

    Time frame: 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

  10. EQ-5D-5L outcome and completion rates

    Time frame: 20 months

    Patient-reported questionnaire assessing health-related quality of life to be administered pre-, 3 months and 6 months post-operatively

Sponsors and collaborators

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust

Other

Collaborators

  • Nottingham University Hospitals NHS Trust
  • Nuffield Orthopaedic Centre NHS Trust
  • University of Exeter
  • Wrightington, Wigan and Leigh NHS Foundation Trust

Registry information

Official study 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

Acronym: MIKROBE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2020
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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