REVISITS: Revision Single or Two Stage Surgery

NCT03741296 | Unknown

• 1 other identifier: 18-0278
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Total Hip Replacement; Arthroplasty Complications

Keywords

Hip replacement; periprosthetic hip infection; single stage revision; two-stage revision

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

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.

Procedure: Single stage revision

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.

Procedure: Two-stage revision

Interventions

Single stage revision PROCEDURE

One-stage exchange hip joint replacement surgery

single stage revision

Two-stage revision PROCEDURE

Two-stage exchange hip joint replacement surgery

two-stage revision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Related Publications (10)

• 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.

  PMID: 26407003 BACKGROUND

• 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.

  PMID: 28790468 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.

  PMID: 26135702 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.

  PMID: 23083433 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.

  PMID: 14516026 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.

  PMID: 16799001 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.

  PMID: 28642256 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.

  PMID: 26064901 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.

  PMID: 29623671 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.

  PMID: 26967645 BACKGROUND

Study Officials

• Amit Atrey, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luana Melo, PhD

CONTACT

416-864-6060; melol@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 14, 2018
• Study Start: April 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2022
• Last Updated: November 14, 2018

Record last verified: 2018-11