InfectionPhase 3ABCNCT01079559
The Effectiveness of Antibiotic Cement (ABC) Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Trial
A Phase 3 study testing Simplex™ P with Tobramycin and Simplex™ P in people with Infection and Osteoarthritis of the Knee, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
Rationale: Infection following total knee replacement (TKA) is a devastating complication that usually requires prosthesis removal, hospitalization while the infection is eradicated, and a second surgery to implant a revision prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Osteoarthritis of the Knee
- What is being tested?
- Simplex™ P with Tobramycin and Simplex™ P
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with osteoarthritis of the knee,
- patients who are undergoing primary knee replacement,
- patients who are able to provide informed consent.
Who cannot join
- patients with a prior joint infection,
- patients who have a known allergy to tobramycin, and
- patients who have no fixed address.
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5W9
About this study
Official title: The Effectiveness of Antibiotic Cement Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Feasibility Study
Rationale: Infection following total knee replacement (TKA) is a devastating complication that usually requires prosthesis removal, hospitalization while the infection is eradicated, and a second surgery to implant a revision prosthesis. For primary TKA, prophylactic antibiotic-loaded cement (ABC) may not only reduce the rate of infection it may also reduce the rate of revisions due to implant loosening. Current controversy about the use of ABC exists around the world. Without a definitive trial, patients will be exposed to a treatment of uncertain efficacy that may cause antibiotic resistant bacterial strains and will certainly generate high costs to the healthcare system. Purpose: To determine, 1) the extent to which ABC compared to regular cement reduces the infection rate in patients over the first two years following TKA and, 2) the resource use implications associated with the use of ABC for TKA. Methods: This is a randomized clinical trial in which 8,800 patients with undergoing primary TKA are allocated to either Simplex™ P with Tobramycin or Simplex™ P bone cement. We will exclude patients with a prior joint infection, an allergy to tobramycin, and those with no fixed address. All patients will be administered IV antibiotics immediately prior to surgery. Patients and surgeons will be blind to group allocation. The primary outcome measure is infection. Follow-up visits will take place at 6 weeks and 3, 12 and 24 months postoperative. A blinded adjudicator will review all reported infections and determine whether the putative infection is a study event. Blinded radiologists will interpret the 2 year series of radiographs for each patient. We will compare the rates of infection and implant loosening between the two treatment groups using survival analyses. This study includes a full economic analysis.
- Conditions
- Infection, Osteoarthritis of the Knee
- Being tested
- Simplex™ P with Tobramycin, Simplex™ P
- Keywords
- total knee arthroplasty, infection, antibiotic bone cement
- Medical subject headings
- Infections, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplex™ P with TobramycinDevice
All patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference.
Simplex™ PDevice
All patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference.
| Study group | Role | What they receive |
|---|---|---|
| Simplex™ P | Active comparator | All patients will receive preoperative antibiotics administered within the hour prior to surgery. All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference. Receives: Device: Simplex™ P |
| Simplex™ P with Tobramycin | Experimental | All patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference. Receives: Device: Simplex™ P with Tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative risk of infection
patients suspected of having an infected total knee replacement in the post-operative period will be evaluated clinically, and will undergo lab evaluation and an aspiration
Measured: 6 weeks and 3, 12 and 24 months postoperative
Secondary outcomes (3)
radiographic evidence of prosthetic failure
Measured: 6 weeks and 3, 12 and 24 months postoperative
patient-reported disease-specific health-related quality of life (HRQOL)
Measured: 6 weeks and 3, 12 and 24 months postoperative
cost-effectiveness
Measured: 6 weeks and 3, 12 and 24 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dianne Bryant, University of Western Ontario, Canada
- Investigators
- Dianne Bryant, PhD, Principal investigator, Western University, CanadaSteven J MacDonald, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079559
- Sponsor's protocol ID
- CIHR-2010-222495
- Acronym
- ABC
- Status last verified
- Feb 2013
- First submitted
- 1 Mar 2010
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Antibiotic Cement Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Feasibility Study
- ClinicalTrials.gov ID
- NCT01079559
- Acronym / sponsor ID
- ABC / CIHR-2010-222495
- Conditions
- Infection, Osteoarthritis of the Knee
- Keywords
- total knee arthroplasty, infection, antibiotic bone cement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Infection following total knee replacement (TKA) is a devastating complication that usually requires prosthesis removal, hospitalization while the infection is eradicated, and a second surgery to implant a revision prosthesis. For primary TKA, prophylactic antibiotic-loaded cement (ABC) may not only reduce the rate of infection it may also reduce the rate of revisions due to implant loosening. Current controversy about the use of ABC exists around the world. Without a definitive trial, patients will be exposed to a treatment of uncertain efficacy that may cause antibiotic resistant bacterial strains and will certainly generate high costs to the healthcare system. Purpose: To determine, 1) the extent to which ABC compared to regular cement reduces the infection rate in patients over the first two years following TKA and, 2) the resource use implications associated with the use of ABC for TKA. Methods: This is a randomized clinical trial in which 8,800 patients with undergoing primary TKA are allocated to either Simplex™ P with Tobramycin or Simplex™ P bone cement. We will exclude patients with a prior joint infection, an allergy to tobramycin, and those with no fixed address. All patients will be administered IV antibiotics immediately prior to surgery. Patients and surgeons will be blind to group allocation. The primary outcome measure is infection. Follow-up visits will take place at 6 weeks and 3, 12 and 24 months postoperative. A blinded adjudicator will review all reported infections and determine whether the putative infection is a study event. Blinded radiologists will interpret the 2 year series of radiographs for each patient. We will compare the rates of infection and implant loosening between the two treatment groups using survival analyses. This study includes a full economic analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simplex™ P | Active comparator | Device: Simplex™ PAll patients will receive preoperative antibiotics administered within the hour prior to surgery. All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference. |
| Simplex™ P with Tobramycin | Experimental | Device: Simplex™ P with TobramycinAll patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with osteoarthritis of the knee,
- patients who are undergoing primary knee replacement,
- patients who are able to provide informed consent.
Key exclusion criteria (3 listed)
- patients with a prior joint infection,
- patients who have a known allergy to tobramycin, and
- patients who have no fixed address.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simplex™ P with TobramycinAll patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference. | Device | Simplex™ P with Tobramycin |
| Simplex™ PAll patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference. | Device | Simplex™ P |
Primary outcome
relative risk of infection
Time frame: 6 weeks and 3, 12 and 24 months postoperative
patients suspected of having an infected total knee replacement in the post-operative period will be evaluated clinically, and will undergo lab evaluation and an aspiration
3 secondary outcomes
radiographic evidence of prosthetic failure
Time frame: 6 weeks and 3, 12 and 24 months postoperative
patient-reported disease-specific health-related quality of life (HRQOL)
Time frame: 6 weeks and 3, 12 and 24 months postoperative
cost-effectiveness
Time frame: 6 weeks and 3, 12 and 24 months postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dianne Bryant, PhD principal investigator
Western University, Canada
Steven J MacDonald, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simplex™ P with Tobramycin and Simplex™ P in people with Infection and Osteoarthritis of the Knee, run by University of Western Ontario, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative risk of infection (time frame: 6 weeks and 3, 12 and 24 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013.