NCT03741296

REVISITS: Revision Single or Two Stage Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Hip Replacement
• Arthroplasty Complications

Interventions

Type	Name	Description
PROCEDURE	Single stage revision	One-stage exchange hip joint replacement surgery
PROCEDURE	Two-stage revision	Two-stage exchange hip joint replacement surgery

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-09-01
• Completion: 2022-12-01
• First posted: 2018-11-14
• Last updated: 2018-11-14