REVISITS: Revision Single or Two Stage Surgery

Unity Health Toronto

Status: Unknown

Conditions: Total Hip Replacement; Arthroplasty Complications

Treatments: Procedure: Single stage revision; Procedure: Two-stage revision

Study type: Interventional

Funder types: Other

Identifiers

NCT03741296

18-0278

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

single stage revision

Active Comparator group

Description:

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.

Treatment:

Procedure: Single stage revision

two-stage revision

Active Comparator group

Description:

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.

Treatment:

Procedure: Two-stage revision