REVISITS Trial: Revision Single or Two Stage Surgery for Periprosthetic Hip Infection - a Multicentre Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Total Hip Replacement
- Sponsor
- Unity Health Toronto
- Enrollment
- 110
- Primary Endpoint
- Patient-reported hip function
- Last Updated
- 7 years ago
Overview
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.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- 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(will be assessed at 6 weeks, 3, 6, 9,12 and 24 months after surgery)
- Patient-reported hip function(Questionnaire will be completed by patients at 12 and 24 months after surgery)
- Visual Analog Pain Scale(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(Will be assessed within 30 days of discharge)
- Hospital length of stay(Will be assessed from admission to discharge (up to 30 days))