Osteoarthritis, KneeNCT04367272
Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.
A study testing First Arthroplasty and Second Arthroplasty in people with Osteoarthritis, Knee and Infection, run by Bezmialem Vakif University.
Trial summary
The effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee, Infection, Periprosthetic Fracture Around Prosthetic Joint Implant
- What is being tested?
- First Arthroplasty and Second Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2020to 30 Jun 2021
- 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 to 75 years
- 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
- less than 75 years old
- severe cardiac insufficiency and morbid obesity
Trial locations and contacts
No sites are listed yet.
About this study
The effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first knee. Therefore, this prospective study compared minor and major local complications for 90 days postoperatively between the first and second during knee single-team simultaneous bilateral total knee arthroplasty.
Read the detailed description
The investigators would like to compare operation related technical complications and periprosthetic joint infection rate between the first and second knee.
- Being tested
- First Arthroplasty, Second Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First ArthroplastyProcedure or surgery
First Knee
Second ArthroplastyProcedure or surgery
Second Knee
| Study group | Role | What they receive |
|---|---|---|
| First Knee | Active comparator | The first knee is the knee where the surgery will begin to be applied. Receives: Procedure: First Arthroplasty |
| Second Knee | Experimental | The second knee is the knee where the surgeon will apply secondly. Receives: Procedure: Second Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local complications
Local operation related complications rate
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 posted29 Apr 2020
- Study start15 May 2020 (estimated)
- Primary completion15 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 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
- NCT04367272
- Sponsor's protocol ID
- 27.04.2020-02
- Status last verified
- Apr 2020
- First submitted
- 25 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT04367272
- Acronym / sponsor ID
- 27.04.2020-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 29 Apr 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 effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first knee. Therefore, this prospective study compared minor and major local complications for 90 days postoperatively between the first and second during knee single-team simultaneous bilateral total knee arthroplasty.
Detailed description
The investigators would like to compare operation related technical complications and periprosthetic joint infection rate between the first and second knee.
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 |
|---|---|---|
| First Knee | Active comparator | Procedure: First ArthroplastyThe first knee is the knee where the surgery will begin to be applied. |
| Second Knee | Experimental | Procedure: Second ArthroplastyThe second knee is the knee where the surgeon will apply secondly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary bilateral knee osteoarthritis with refractory to conservative treatment
- Patients who accept participation in the research and the randomization
Key exclusion criteria (3 listed)
- no history of malignancy
- less than 75 years old
- severe cardiac insufficiency and morbid obesity
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 |
|---|---|---|
| First ArthroplastyFirst Knee | Procedure or surgery | First Knee |
| Second ArthroplastySecond Knee | Procedure or surgery | Second Knee |
Primary outcome
Local complications
Time frame: 90 days
Local operation related complications rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing First Arthroplasty and Second Arthroplasty in people with Osteoarthritis, Knee and Infection, run by Bezmialem Vakif University.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Orkhan Aliyev, MD (+905059917419, orkhanaliyev@outlook.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local complications (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 30 Apr 2020.