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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single stage revision | Active Comparator | 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. |
|
| two-stage revision | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single stage revision | Procedure | One-stage exchange hip joint replacement surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported hip function | 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 | Questionnaire will be completed by patients at 9 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Health status and quality of life | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luana Melo, PhD | Contact | 416-864-6060 | melol@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Amit Atrey, MD | Unity Health Toronto | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26407003 | Background | 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. | |
| 28790468 | Background |
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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.
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| Two-stage revision |
| Procedure |
Two-stage exchange hip joint replacement surgery |
|
| Questionnaire will be completed by patients before the surgery and at 6, 9, 12 and 24 months after surgery |
| Reinfection rates | Recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the Musculoskeletal Infection Society criteria.
| will be assessed at 6 weeks, 3, 6, 9,12 and 24 months after surgery |
| Patient-reported hip function | 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 | Questionnaire will be completed by patients at 12 and 24 months after surgery |
| Visual Analog Pain Scale | 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) | 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 | 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 | Will be assessed within 30 days of discharge |
| Hospital length of stay | The duration of a single episode of hospitalization (in days) | Will be assessed from admission to discharge (up to 30 days) |
| 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. |
| 26135702 | Background | 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. |
| 23083433 | Background | 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. |
| 14516026 | Background | 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. |
| 16799001 | Background | 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. |
| 28642256 | Background | 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. |
| 26064901 | Background | 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. |
| 29623671 | Background | 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. |
| 26967645 | Background | 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. |