NCT04458961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 17, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

June 5, 2020

Last Update Submit

November 15, 2023

Conditions

Arthroplasty, Replacement, Knee

Keywords

ArthropathyArthropathy Related to InfectionArthropathy of Knee JointOne-stageTwo-stageInfectionProsthetic joint infection

Outcome Measures

Primary Outcomes (1)

  • Ease of recruitment of participants

    Number of recruits compared to the number of potential participants.

    20 months

Secondary Outcomes (10)

  • Explaining the study

    20 months

  • Reasons for non-participation

    20 months

  • Patient experience

    2 weeks after surgery

  • Surgeon experience

    20 months

  • Protocol adherence

    20 months

  • +5 more secondary outcomes

Study Arms (2)

One-stage

ACTIVE COMPARATOR
Procedure: One-stage

Two-stage

ACTIVE COMPARATOR
Procedure: Two-stage

Interventions

One-stagePROCEDURE

A one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately.

One-stage
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.

Two-stage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Exeter, Devon, EX2 5DW, United Kingdom

Location

Nuffiels Orthopaedic Centre (NOC)

Oxford, United Kingdom

Location

Related Publications (1)

  • Terry R, Dean S, Hourigan P, Waterson HB, Wylde V, Carpenter N, Whale B, Powell RJ, Tarrant P, Medina-Lara A, Alvand A, Toms AD. MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection. Pilot Feasibility Stud. 2025 Apr 16;11(1):49. doi: 10.1186/s40814-025-01634-4.

    PMID: 40241215DERIVED

MeSH Terms

Conditions

Joint DiseasesInfections

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

  • Andrew Toms, FRCS

    Royal Devon and Exeter NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding of participants and trial personnel will not be possible due to the nature of the intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2020

First Posted

July 7, 2020

Study Start

November 17, 2020

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

GB(2)