Osteoarthritis, KneePhase 2ALBANCT04135170
Antibiotic Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty
A Phase 2 study testing ALBC vs plain bone cement in people with Osteoarthritis, Knee, run by The Norwegian Arthroplasty Register at 1 site in Norway.
Trial summary
Introduction: The current evidence on the efficacy of Antibiotic Loaded Bone Cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- ALBC vs plain bone cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,172 participants
- Where
- 1 siteNorway
- Study dates
- 14 Jan 2021to 31 Dec 2025
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients undergoing full-cemented primary TKA irrespective of the diagnosis leading to TKA
Who cannot join
- any history of infection in the knee, a need for fully stabilized or hinged TKA, a history of allergy to the antibiotics used in the cement, inability or not willing to consent for inclusion in NAR or the trial, and participation in other studies that might have pharmacological interaction with this trial.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Department of Orthopeadic Surgery, Haukeland University Hospital
Bergen
Ove Furnes, PhD, 55975690 ext. 0047, ove.nord.furnes@helse-bergen.no
About this study
Official title: Antibiotic Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicenter Randomized Controlled Non-inferiority Trial (Acronym: ALBA Trial)
Introduction: The current evidence on the efficacy of Antibiotic Loaded Bone Cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the US where ALBC use is not approved in low-risk patients. It has been claimed that the antibiotic in ALBC increase the risk of aseptic loosening, risk of systemic toxicity, allergic reaction, and bacterial resistance. Therefore we designed a double-blinded (patients and data analysts) pragmatic multicenter register-based randomized controlled non-inferiority trial to investigate the effects of ALBC compared to plain bone cement in primary total knee arthroplasty (TKA).
Methods and analysis: A minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomized into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. . The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be:
Read more
- risk of revision due to any reason including aseptic loosening at 1-, 6-, 10-, and 20-years of follow-up;
- patient related outcome measures (PROMs) like function, pain, satisfaction, and health-related quality of life at 1-, 6-, and 10-years of follow-up;
- risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions at 1-, 6-, 10-, and 20-years of follow-up; and
- cost-effectiveness of routine ALBC vs plain bone cement use in primary TKA. We will use 1:1 randomization with random permuted blocks and stratify by participating hospitals to randomize patients to receive ALBC or plain bone cement. Inclusion, randomization, and follow-up will be through the Norwegian Arthroplasty Register.
Ethics and dissemination: The trial has been approved by the Western Norway Regional Committees on Medical and Health Research Ethics (REK-Vest) (reference number: 2019/751/REK vest) dated: 21.06.2019. The trial results will be reported following the Consolidated Standards of Reporting Trials Extension (CONSORT Extension) reporting guideline 2010 statement for non-inferiority trials. The trial results will be reported to the public through national and international scientific conferences, participating hospitals, patient organizations, and peer-reviewed journals.
Discussion: If we find that plain bone cement is non-inferior to the ALBC, it will challenge the routine use of ALBC in primary arthroplasty, due to ecological concerns and costs. However, if routine use of ALBC is associated with a reduced risk of PJI and with minor impact on bacterial resistance, PROMs, and costs, the well-established use of prophylactic ALBC in primary arthroplasty will be supported
- Conditions
- Osteoarthritis, Knee
- Being tested
- ALBC vs plain bone cement
- Keywords
- Register based randomized control trial, Non-inferiority, Total knee arthroplasty, Antibiotic loaded bone cement, Plain bone cement, Antibiotic resistance bacteria, Periprosthetic joint infection, Patient reported outcome measure, Health related quality of life, Pain, Function, Satisfaction, Revision surgery, Primary surgery
- Medical subject headings
- Osteoarthritis, Knee, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALBC vs plain bone cementCombination product
The patients undergoing full-cemented primary total knee arthroplasty are allocated to either ALBC or plain bone cement and compare the effectiveness of ALBC use vs pain bone cement bone cement without antibiotic) with respect to revision due to PJI one year after primary TKA surgery.
| Study group | Role | What they receive |
|---|---|---|
| Plain bone cement | Experimental | Not described Receives: Combination Product: ALBC vs plain bone cement |
| Antibiotic loaded bone cement | Active comparator | Not described Receives: Combination Product: ALBC vs plain bone cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of revision due to PJI
Measured: 1-year follow-up
Secondary outcomes (6)
risk of revision due to any reason including aseptic loosening
Measured: 1-, 6-, 10-, and 20-years follow-up
risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions
Measured: 1-, 6-, 10-, and 20-years follow-up
Change in mean scores from baseline function (in activity of daily life) on the Knee injury and Osteoarthritis Outcome Score (KOOS).
Measured: 1-, 6-, and 10-years follow-up
Change in mean scores from baselinein in Visual Analog Sale (the scores range from 0 to 100, with 0 indicating the worst possible state and 100 indicating the best possible state) for pain.
Measured: 1-, 6-, and 10-years follow-up
Change in mean scores from baseline in EQ-5D-5L for health related quality of life(HRQoL).
Measured: 1-, 6-, and 10-years follow-up
Mean scores in Visual Analog Sale ( the scores range from 0 to 100, with 0 indicating the worst possible state and 100 indicating the best possible state) for patient satisfaction.
Measured: 1-, 6-, and 10-years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start14 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing full-cemented primary TKA in any Norwegian hospitals are eligible for participation irrespectively of the diagnosis leading to TKA. and randomly assigned to receive ALBC (control group) or plain bone cement (experimental group).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9,172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Norwegian Arthroplasty Register
- Sponsor type
- Other government
- Collaborators
- Helse Vest
- Responsible party
- Principal investigator, Asst. professor Tesfaye Hordofa Leta (Nurse, Postdoc fellow), The Norwegian Arthroplasty Register
- Investigators
- Ove Furnes, MD/PhD, Study chair, The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135170
- Sponsor's protocol ID
- NorwegianArthroplastyRegister
- Acronym
- ALBA
- Status last verified
- Jan 2021
- First submitted
- 20 Sep 2019
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leta TH, Gjertsen JE, Dale H, Hallan G, Lygre SHL, Fenstad AM, Dyrhovden GS, Westberg M, Wik TS, Jakobsen RB, Aamodt A, Rohrl SM, Gothesen OJ, Lindalen E, Heir S, Ludvigsen J, Bruun T, Hansen AK, Aune KEM, Warholm M, Skjetne JP, Badawy M, Hovding P, Husby OS, Karlsen OE, Furnes O. Antibiotic-Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicentre Randomised Controlled Non-inferiority Trial (ALBA trial). BMJ Open. 2021 Jan 28;11(1):e041096. doi: 10.1136/bmjopen-2020-041096.
PubMed 33509845
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicenter Randomized Controlled Non-inferiority Trial (Acronym: ALBA Trial)
- ClinicalTrials.gov ID
- NCT04135170
- Acronym / sponsor ID
- ALBA / NorwegianArthroplastyRegister
- Conditions
- Osteoarthritis, Knee
- Keywords
- Register based randomized control trial, Non-inferiority, Total knee arthroplasty, Antibiotic loaded bone cement, Plain bone cement, Antibiotic resistance bacteria, Periprosthetic joint infection, Patient reported outcome measure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,172 participants (estimated)
- Lead sponsor
- The Norwegian Arthroplasty RegisterOther government
- Collaborators
- Helse Vest
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Oct 2019 (actual)
- 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.
Introduction: The current evidence on the efficacy of Antibiotic Loaded Bone Cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the US where ALBC use is not approved in low-risk patients. It has been claimed that the antibiotic in ALBC increase the risk of aseptic loosening, risk of systemic toxicity, allergic reaction, and bacterial resistance. Therefore we designed a double-blinded (patients and data analysts) pragmatic multicenter register-based randomized controlled non-inferiority trial to investigate the effects of ALBC compared to plain bone cement in primary total knee arthroplasty (TKA).
Methods and analysis: A minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomized into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. . The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be:
- risk of revision due to any reason including aseptic loosening at 1-, 6-, 10-, and 20-years of follow-up;
- patient related outcome measures (PROMs) like function, pain, satisfaction, and health-related quality of life at 1-, 6-, and 10-years of follow-up;
- risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions at 1-, 6-, 10-, and 20-years of follow-up; and
- cost-effectiveness of routine ALBC vs plain bone cement use in primary TKA. We will use 1:1 randomization with random permuted blocks and stratify by participating hospitals to randomize patients to receive ALBC or plain bone cement. Inclusion, randomization, and follow-up will be through the Norwegian Arthroplasty Register.
Ethics and dissemination: The trial has been approved by the Western Norway Regional Committees on Medical and Health Research Ethics (REK-Vest) (reference number: 2019/751/REK vest) dated: 21.06.2019. The trial results will be reported following the Consolidated Standards of Reporting Trials Extension (CONSORT Extension) reporting guideline 2010 statement for non-inferiority trials. The trial results will be reported to the public through national and international scientific conferences, participating hospitals, patient organizations, and peer-reviewed journals.
Discussion: If we find that plain bone cement is non-inferior to the ALBC, it will challenge the routine use of ALBC in primary arthroplasty, due to ecological concerns and costs. However, if routine use of ALBC is associated with a reduced risk of PJI and with minor impact on bacterial resistance, PROMs, and costs, the well-established use of prophylactic ALBC in primary arthroplasty will be supported
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients undergoing full-cemented primary TKA in any Norwegian hospitals are eligible for participation irrespectively of the diagnosis leading to TKA. and randomly assigned to receive ALBC (control group) or plain bone cement (experimental group).
| Arm | Type | Receives |
|---|---|---|
| Plain bone cement | Experimental | Combination Product: ALBC vs plain bone cement |
| Antibiotic loaded bone cement | Active comparator | Combination Product: ALBC vs plain bone cement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing full-cemented primary TKA irrespective of the diagnosis leading to TKA
Key exclusion criteria (1 listed)
- any history of infection in the knee, a need for fully stabilized or hinged TKA, a history of allergy to the antibiotics used in the cement, inability or not willing to consent for inclusion in NAR or the trial, and participation in other studies that might have pharmacological interaction with this trial.
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 |
|---|---|---|
| ALBC vs plain bone cementThe patients undergoing full-cemented primary total knee arthroplasty are allocated to either ALBC or plain bone cement and compare the effectiveness of ALBC use vs pain bone cement bone cement without antibiotic) with respect to revision due to PJI one year after primary TKA surgery. | Combination product | Antibiotic loaded bone cement, Plain bone cement |
Primary outcome
risk of revision due to PJI
Time frame: 1-year follow-up
6 secondary outcomes
risk of revision due to any reason including aseptic loosening
Time frame: 1-, 6-, 10-, and 20-years follow-up
risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions
Time frame: 1-, 6-, 10-, and 20-years follow-up
Change in mean scores from baseline function (in activity of daily life) on the Knee injury and Osteoarthritis Outcome Score (KOOS).
Time frame: 1-, 6-, and 10-years follow-up
Change in mean scores from baselinein in Visual Analog Sale (the scores range from 0 to 100, with 0 indicating the worst possible state and 100 indicating the best possible state) for pain.
Time frame: 1-, 6-, and 10-years follow-up
Change in mean scores from baseline in EQ-5D-5L for health related quality of life(HRQoL).
Time frame: 1-, 6-, and 10-years follow-up
Mean scores in Visual Analog Sale ( the scores range from 0 to 100, with 0 indicating the worst possible state and 100 indicating the best possible state) for patient satisfaction.
Time frame: 1-, 6-, and 10-years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 33509845Leta TH, Gjertsen JE, Dale H, Hallan G, Lygre SHL, Fenstad AM, Dyrhovden GS, Westberg M, Wik TS, Jakobsen RB, Aamodt A, Rohrl SM, Gothesen OJ, Lindalen E, Heir S, Ludvigsen J, Bruun T, Hansen AK, Aune KEM, Warholm M, Skjetne JP, Badawy M, Hovding P, Husby OS, Karlsen OE, Furnes O. Antibiotic-Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicentre Randomised Controlled Non-inferiority Trial (ALBA trial). BMJ Open. 2021 Jan 28;11(1):e041096. doi: 10.1136/bmjopen-2020-041096.
- Individual participant dataSharing planned: No
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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.
Ove Furnes, MD/PhD study chair
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALBC vs plain bone cement in people with Osteoarthritis, Knee, run by The Norwegian Arthroplasty Register at 1 site in Norway.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jan 2021. 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 Norway. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tesfaye H Leta, PhD (+4791691925, tesfaye.hordofa.leta@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of revision due to PJI (time frame: 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04135170, which also lists 1 linked publication.
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 19 Jan 2021.