Arthroplasty, Replacement, KneeMIKROBENCT04458961
MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence
A study testing One-stage and Two-stage in people with Arthroplasty, Replacement, Knee, run by Royal Devon and Exeter NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- One-stage and Two-stage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 17 Nov 2020to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter NHS Trust (RD&E NHSFT)
Exeter, Devon, EX2 5DW
Nuffiels Orthopaedic Centre (NOC)
Oxford
About this study
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
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.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- One-stage, Two-stage
- Keywords
- Arthropathy, Arthropathy Related to Infection, Arthropathy of Knee Joint, One-stage, Two-stage, Infection, Prosthetic joint infection
- Medical subject headings
- Joint Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-stageProcedure or surgery
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-stageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| One-stage | Active comparator | Not described Receives: Procedure: One-stage |
| Two-stage | Active comparator | Not described Receives: Procedure: Two-stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of recruitment of participants
Number of recruits compared to the number of potential participants.
Measured: 20 months
Secondary outcomes (10)
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.
Measured: 20 months
Reasons for non-participation
Qualitative analysis of semi-structured interviews with those patients who declined to participate in the trial.
Measured: 20 months
Patient experience
Experience and acceptability of the process of recruitment, randomisation and study participation via qualitative analysis of semi-structured interview.
Measured: 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.
Measured: 20 months
Protocol adherence
Assessment of any deviations or violations to protocol that occur during the trial.
Measured: 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
Measured: 20 months
Comparison of two sites
Recruitment and attrition rates at the two sites
Measured: 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
Measured: 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
Measured: 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
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start17 Nov 2020
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter, Nuffield Orthopaedic Centre NHS Trust, Nottingham University Hospitals NHS Trust, Wrightington, Wigan and Leigh NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andrew Toms, FRCS, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458961
- Sponsor's protocol ID
- 272334
- Acronym
- MIKROBE
- Status last verified
- Nov 2023
- First submitted
- 5 Jun 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40241215
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04458961
- Acronym / sponsor ID
- MIKROBE / 272334
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Arthropathy, Arthropathy Related to Infection, Arthropathy of Knee Joint, One-stage, Two-stage, Infection, Prosthetic joint infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter, Nuffield Orthopaedic Centre NHS Trust, Nottingham University Hospitals NHS Trust, Wrightington, Wigan and Leigh NHS Foundation Trust
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-stage | Active comparator | Procedure: One-stage |
| Two-stage | Active comparator | Procedure: Two-stage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-stageA one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately. | Procedure or surgery | One-stage |
| Two-stageA 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. | Procedure or surgery | Two-stage |
Primary outcome
Ease of recruitment of participants
Time frame: 20 months
Number of recruits compared to the number of potential participants.
10 secondary outcomes
Explaining the study
Time frame: 20 months
Reasons for non-participation
Time frame: 20 months
Patient experience
Time frame: 2 weeks after surgery
Surgeon experience
Time frame: 20 months
Protocol adherence
Time frame: 20 months
Healthcare resource utilisation
Time frame: 20 months
Comparison of two sites
Time frame: 20 months
Knee injury and Osteoarthritis Outcome Score (KOOS) outcome and completion rates
Time frame: 20 months
Oxford Knee Score (OKS) outcome and completion rates
Time frame: 20 months
EQ-5D-5L outcome and completion rates
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 40241215Terry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Toms, FRCS principal investigator
Royal Devon and Exeter NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-stage and Two-stage in people with Arthroplasty, Replacement, Knee, run by Royal Devon and Exeter NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of recruitment of participants (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04458961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.