MIKROBE Management of Infected Knee Replacements-Obtaining Best Evidence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-17

Study Completion Date

2023-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate Patient Outcomes and Safety and Effectiveness of Robotic Assisted Unicompartmental Knee Replacements Versus Conventional Unicompartmental Knee for Subjects With Primary Arthritis of the Knee Joint Involving One (UKA) Compartment (Medial or Lateral)

NCT06036212

Arthroplasty, Replacement, Knee Unicompartmental Knee Arthroplasty

WITHDRAWN NA

Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

NCT00862316

Knee Arthritis

COMPLETED NA

Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants

NCT05876143

Unicompartmental Knee Arthroplasty

RECRUITING

Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses

NCT02860767

Prosthesis-Related Infections

COMPLETED

RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty

NCT04095637

Unicompartmental Knee Replacement Osteo Arthritis Knee Surgery

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arthroplasty, Replacement, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Blinding of participants and trial personnel will not be possible due to the nature of the intervention

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

One-stage

Group Type ACTIVE_COMPARATOR

One-stage

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Two-stage

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No