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REVISITS: Revision Single or Two Stage Surgery (REVISITS)

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ClinicalTrials.gov Identifier: NCT03741296
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Total Hip Replacement Arthroplasty Complications Procedure: Single stage revision Procedure: Two-stage revision Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a study is a multicentre, prospective, parallel, two-arm, randomized controlled trial aiming to assess the efficacy of single stage revision peri-prosthetic joint infection of hip arthroplasty in adult's patients, compared to the current gold standard of care, two-stage revision.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REVISITS Trial: Revision Single or Two Stage Surgery for Periprosthetic Hip Infection - a Multicentre Randomized Clinical Trial
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741296


Contacts
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Contact: Luana Melo, PhD 416-864-6060 melol@smh.ca

Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Amit Atrey, MD St. Michael's Hospital, Toronto

Publications:

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03741296     History of Changes
Other Study ID Numbers: 18-0278
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Michael's Hospital, Toronto:
Hip replacement
periprosthetic hip infection
single stage revision
two-stage revision