Clinical trial NCT03741296: REVISITS: Revision Single or Two Stage Surgery
Official title: REVISITS Trial: Revision Single or Two Stage Surgery for Periprosthetic Hip Infection - a Multicentre Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Replacement
Arthroplasty Complications
Keywords: Hip replacement
periprosthetic hip infection
single stage revision
two-stage revision
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient-reported hip function
timeFrame: Questionnaire will be completed by patients at 9 months after surgery
Secondary outcomes:
measure: Health status and quality of life
timeFrame: Questionnaire will be completed by patients before the surgery and at 6, 9, 12 and 24 months after surgery
measure: Reinfection rates
timeFrame: will be assessed at 6 weeks, 3, 6, 9,12 and 24 months after surgery
measure: Patient-reported hip function
timeFrame: Questionnaire will be completed by patients at 12 and 24 months after surgery
measure: Visual Analog Pain Scale
timeFrame: 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
measure: Hospital readmission
timeFrame: Will be assessed within 30 days of discharge
measure: Hospital length of stay
timeFrame: Will be assessed from admission to discharge (up to 30 days)
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto
name: Amit Atrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kunutsor SK, Whitehouse MR, Blom AW, Beswick AD; INFORM Team. Re-Infection Outcomes following One- and Two-Stage Surgical Revision of Infected Hip Prosthesis: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 25;10(9):e0139166. doi: 10.1371/journal.pone.0139166. eCollection 2015.
citation: Lopez D, Leach I, Moore E, Norrish AR. Management of the Infected Total Hip Arthroplasty. Indian J Orthop. 2017 Jul-Aug;51(4):397-404. doi: 10.4103/ortho.IJOrtho_307_16.
citation: Kapadia BH, Berg RA, Daley JA, Fritz J, Bhave A, Mont MA. Periprosthetic joint infection. Lancet. 2016 Jan 23;387(10016):386-394. doi: 10.1016/S0140-6736(14)61798-0. Epub 2015 Jun 28.
citation: Dale H, Fenstad AM, Hallan G, Havelin LI, Furnes O, Overgaard S, Pedersen AB, Karrholm J, Garellick G, Pulkkinen P, Eskelinen A, Makela K, Engesaeter LB. Increasing risk of prosthetic joint infection after total hip arthroplasty. Acta Orthop. 2012 Oct;83(5):449-58. doi: 10.3109/17453674.2012.733918.
citation: Blom AW, Taylor AH, Pattison G, Whitehouse S, Bannister GC. Infection after total hip arthroplasty. The Avon experience. J Bone Joint Surg Br. 2003 Sep;85(7):956-9. doi: 10.1302/0301-620x.85b7.14095.
citation: Phillips JE, Crane TP, Noy M, Elliott TS, Grimer RJ. The incidence of deep prosthetic infections in a specialist orthopaedic hospital: a 15-year prospective survey. J Bone Joint Surg Br. 2006 Jul;88(7):943-8. doi: 10.1302/0301-620X.88B7.17150.
citation: Lenguerrand E, Whitehouse MR, Beswick AD, Jones SA, Porter ML, Blom AW. Revision for prosthetic joint infection following hip arthroplasty: Evidence from the National Joint Registry. Bone Joint Res. 2017 Jun;6(6):391-398. doi: 10.1302/2046-3758.66.BJR-2017-0003.R1.
citation: Chen SY, Hu CC, Chen CC, Chang YH, Hsieh PH. Two-Stage Revision Arthroplasty for Periprosthetic Hip Infection: Mean Follow-Up of Ten Years. Biomed Res Int. 2015;2015:345475. doi: 10.1155/2015/345475. Epub 2015 Apr 29.
citation: Kunutsor SK, Whitehouse MR, Blom AW, Board T, Kay P, Wroblewski BM, Zeller V, Chen SY, Hsieh PH, Masri BA, Herman A, Jenny JY, Schwarzkopf R, Whittaker JP, Burston B, Huang R, Restrepo C, Parvizi J, Rudelli S, Honda E, Uip DE, Bori G, Munoz-Mahamud E, Darley E, Ribera A, Canas E, Cabo J, Cordero-Ampuero J, Redo MLS, Strange S, Lenguerrand E, Gooberman-Hill R, Webb J, MacGowan A, Dieppe P, Wilson M, Beswick AD; Global Infection Orthopaedic Management Collaboration. One- and two-stage surgical revision of peri-prosthetic joint infection of the hip: a pooled individual participant data analysis of 44 cohort studies. Eur J Epidemiol. 2018 Oct;33(10):933-946. doi: 10.1007/s10654-018-0377-9. Epub 2018 Apr 5.
citation: Kunutsor SK, Whitehouse MR, Lenguerrand E, Blom AW, Beswick AD; INFORM Team. Re-Infection Outcomes Following One- And Two-Stage Surgical Revision of Infected Knee Prosthesis: A Systematic Review and Meta-Analysis. PLoS One. 2016 Mar 11;11(3):e0151537. doi: 10.1371/journal.pone.0151537. eCollection 2016.