Infection JointNCT04413565
Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
A study testing Simultaneous bilateral total knee arthroplasty and Sequenced bilateral TKA in people with Infection Joint and Joint Infection, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Joint, Joint Infection, Arthroplasty Complications
- What is being tested?
- Simultaneous bilateral total knee arthroplasty and Sequenced bilateral TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2016to 31 Dec 2020
- Phase
- Interventional
- 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
- Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization
Who cannot join
- no history of malignancy without severe extra-articular deformities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Fatih, 34000
Orkhan Aliyev, 05059917419, orkhanaliyev@outlook.com.tr
About this study
The use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as the indications for TKR continue to increase. Investigators will prospectively compare the incidence of periprosthetic joint infection between groups.
Read the detailed description
924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons bilateral TKA and single surgeon bilateral TKA. While 2 surgeons will perform simultaneous total knee arthroplasty in the two surgeons' bilateral TKA group, one surgeon will perform sequentially in the single surgeon bilateral TKA group. The primary outcome is to compare the incidence of PJI between the groups. Secondary, logistic regression use to estimate the effect of two surgeons bilateral TKA and single surgeon bilateral TKA on the likelihood of a patient being infected.
- Conditions
- Infection Joint, Joint Infection, Arthroplasty Complications
- Being tested
- Simultaneous bilateral total knee arthroplasty, Sequenced bilateral TKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous bilateral total knee arthroplastyProcedure or surgery
Two surgeon bilateral TKA group
Sequenced bilateral TKAProcedure or surgery
Single surgeon bilateral TKA group
| Study group | Role | What they receive |
|---|---|---|
| Two surgeon bilateral TKA group | Experimental | 2 surgeons will perform simultaneous total knee arthroplasty in this group. Receives: Procedure: Simultaneous bilateral total knee arthroplasty |
| Single surgeon bilateral TKA group | Active comparator | One surgeon will perform sequentially tptal knee arthroplasty in this group Receives: Procedure: Sequenced bilateral TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection incedence
Early infection rates
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start8 Dec 2016
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection JointStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 413 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkhan Aliyev, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413565
- Sponsor's protocol ID
- 08.12.2016-71306642-050.01.04
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04413565
- Acronym / sponsor ID
- 08.12.2016-71306642-050.01.04
- Conditions
- Infection Joint, Joint Infection, Arthroplasty Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 413 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Jun 2020 (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.
The use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as the indications for TKR continue to increase. Investigators will prospectively compare the incidence of periprosthetic joint infection between groups.
Detailed description
924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons bilateral TKA and single surgeon bilateral TKA. While 2 surgeons will perform simultaneous total knee arthroplasty in the two surgeons' bilateral TKA group, one surgeon will perform sequentially in the single surgeon bilateral TKA group. The primary outcome is to compare the incidence of PJI between the groups. Secondary, logistic regression use to estimate the effect of two surgeons bilateral TKA and single surgeon bilateral TKA on the likelihood of a patient being infected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two surgeon bilateral TKA group | Experimental | Procedure: Simultaneous bilateral total knee arthroplasty2 surgeons will perform simultaneous total knee arthroplasty in this group. |
| Single surgeon bilateral TKA group | Active comparator | Procedure: Sequenced bilateral TKAOne surgeon will perform sequentially tptal knee arthroplasty in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization
Key exclusion criteria (1 listed)
- no history of malignancy without severe extra-articular deformities
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 |
|---|---|---|
| Simultaneous bilateral total knee arthroplastyTwo surgeon bilateral TKA group | Procedure or surgery | Two surgeon bilateral TKA group |
| Sequenced bilateral TKASingle surgeon bilateral TKA group | Procedure or surgery | Single surgeon bilateral TKA group |
Primary outcome
Infection incedence
Time frame: 90 days
Early infection rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous bilateral total knee arthroplasty and Sequenced bilateral TKA in people with Infection Joint and Joint Infection, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 4 Jun 2020. 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 Turkey (Türkiye). 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection incedence (time frame: 90 days). 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 4 Jun 2020.