REVISITS: Revision Single or Two Stage Surgery (REVISITS)

November 12, 2018 updated by: Unity Health Toronto

REVISITS Trial: Revision Single or Two Stage Surgery for Periprosthetic Hip Infection - a Multicentre Randomized Clinical Trial

Hip replacement surgery is common, with over 60,000 cases in Canada annually. After hip replacement, about 1-2% patients develop a deep infection in their artificial hip implant, called a periprosthetic joint infection (PJI). It can results in severe pain, disability and death.

There are two types of surgical treatment: a single-stage revision that involves removing the joint, thoroughly cleaning the infected area and implanting a new joint, all in the same surgical procedure; a two-stage revision involves removing the joint, waiting at least 8 weeks while treating the patients with antibiotics and then doing re-implantation of the joint.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Peri-prosthetic infection is an uncommon but severe complication of joint replacement (arthroplasty) with a reported rate between 0.6 to 2.2%. Although the likelihood of infection is relatively small, the psychological and economic impact, as well as long-term implications to both the patient and healthcare system, can be catastrophic.

The current gold standard treatment for peri-prosthetic infection is a two-stage strategy, where the artificial hip joint is removed and a new replacement delayed for at least 8 weeks until clear evidence of infection eradication is obtained. During this time the patient may be non-ambulatory, non- or partial-weight bearing and then a wait for re-listing for the second surgery.

An alternative treatment that has recently been more widely used is to perform a single stage revision. That involves removing the implants and then irrigating and debriding and finally implanting the new replacements prostheses. This is all done in one surgery. The advantage of this technique is that there is only one procedure and usually the patient is allowed to bear weight on the joint.

Primary Objective:

To compare pain and physical function assessed by the Oxford hip score, between the single and two-stage revision surgery for a periprosthetic hip infection in adults

Secondary Objectives:

To compare pain, function, quality of life, rates of reinfection, complications, cost-effectiveness and health economic impact.

Tertiary Objectives:

To involve building partnerships between patients, researchers and clinicians. Patients will be engaged in the trial development and knowledge translation.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients aged 18 years or above
  • A clinical diagnosis of deep hip periprosthetic joint infection according to the Musculoskeletal Infection Society criteria
  • Require revision surgery (either single-or two-stage revision) for hip periprosthetic joint infection in the opinion of the treating consultant orthopaedic surgeon
  • The patient is not a candidate for Debridement, Antibiotics and Implant Retention (DAIR) treatment with retention of the implant
  • Willing and able to sign the written consent, follow the protocol and attend follow-up
  • Able to read and understand English

Exclusion Criteria:

  • Culture-negative infection (organism not identified)
  • Patients with systemic sepsis who require emergent surgery
  • Resistant organisms not sensitive to available intravenous antibiotics
  • Revision surgery or previous two-stage reimplant
  • Unable or unwilling to undergo either single-or two-stage revision surgery
  • Cognitive impairment (dementia, Alzheimer, etc.) which will prevent patients from completing the primary outcome measure
  • Medical contra-indication to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: single stage revision
One surgery where the infected artificial joint will be removed along with all components, cement, and any potentially infected material. The surgical site will be debrided and washed out before a new artificial hip joint (prosthesis) is implanted. All the procedures will be done in a single surgery.
Procedure: Single stage revision
One-stage exchange hip joint replacement surgery
ACTIVE_COMPARATOR: two-stage revision

Patients will undergo 2 separated surgeries. In the first operation, the infected artificial joint will be removed along with all components, cement, and any potentially infected material. The surgical site will be debrided, washed out and a spacer will be placed in the hip (temporarily replace prosthesis).

A secondary surgery to re-implant the hip will be performed with an interval period of 4-10 weeks when the infection is cleared.

The site will be debrided and irrigated, and any component/spacer will be removed. A new artificial joint will then be implanted.
Procedure: Two-stage revision
Two-stage exchange hip joint replacement surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported hip function
Time Frame: Questionnaire will be completed by patients at 9 months after surgery
Measured by means of the Oxford Hip Score - A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after hip replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function
Questionnaire will be completed by patients at 9 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health status and quality of life
Time Frame: Questionnaire will be completed by patients before the surgery and at 6, 9, 12 and 24 months after surgery
EuroQol-5D (EQ-5D-5L) is a questionnaire where patients self-rate their level of severity of health status and health-related quality of life. Consists of 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each one of them has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) where patients will indicate how they feel regarding their health status and quality of life.
Questionnaire will be completed by patients before the surgery and at 6, 9, 12 and 24 months after surgery
Reinfection rates
Time Frame: will be assessed at 6 weeks, 3, 6, 9,12 and 24 months after surgery

Recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the Musculoskeletal Infection Society criteria.

  1. There is a sinus tract communicating with the prosthesis; or
  2. A pathogen is isolated by culture from at least two separate tissue or fluid samples obtained from the affected prosthetic joint; or

  3. Four of the following six criteria exist:

    1. Elevated serum erythrocyte sedimentation rate (ESR) and serum C-reactive protein (CRP) concentration
    2. Elevated synovial leukocyte count,
    3. Elevated synovial neutrophil percentage (PMN%)
    4. Presence of purulence in the affected joint
    5. Isolation of a microorganism in one culture of periprosthetic tissue or fluid
    6. Greater than five neutrophils per high-power field in five high-power fields observed from histologic analysis of periprosthetic tissue at 400x magnification
will be assessed at 6 weeks, 3, 6, 9,12 and 24 months after surgery
Patient-reported hip function
Time Frame: Questionnaire will be completed by patients at 12 and 24 months after surgery
Measured by means of the Oxford Hip Score - A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after hip replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function
Questionnaire will be completed by patients at 12 and 24 months after surgery
Visual Analog Pain Scale
Time Frame: Pain scale will be assessed before the surgery and at 24 and 48 hours, 6 weeks, 3,6, 9, 12 and 24 months after surgery
Assess pain from a visual scale that ranges from 0 to 10. Straight line with the endpoints defining extreme limits such as 'no pain at all' (zero) and 'pain as bad as it could be' (ten)
Pain scale will be assessed before the surgery and at 24 and 48 hours, 6 weeks, 3,6, 9, 12 and 24 months after surgery
Hospital readmission
Time Frame: Will be assessed within 30 days of discharge
If patients who were discharged after surgery have an unplanned readmission for any cause to an hospital, the reason for readmission being related or not to the surgery
Will be assessed within 30 days of discharge
Hospital length of stay
Time Frame: Will be assessed from admission to discharge (up to 30 days)
The duration of a single episode of hospitalization (in days)
Will be assessed from admission to discharge (up to 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2019

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 12, 2018

First Posted (ACTUAL)

November 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-0278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthroplasty Complications

Clinical Trials on Single stage revision

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe