Gonarthrosis; PrimaryNCT04434690
Radiologic Results 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 Gonarthrosis; Primary, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral TKA), and single-stage, a sequential bilateral… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Gonarthrosis; Primary
- 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
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 31 Oct 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 35 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 without severe extra-articular deformities severe cardiac insufficiency and morbid obesity without systemic inflammatory diseases
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
Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral TKA), and single-stage, a sequential bilateral TKA (single surgeon bilateral TKA). The purpose of this study is to evaluate the radiological results in the single-stage bilateral TKA in terms of two surgeons bilateral TKA and single surgeon bilateral TKA.
Read the detailed description
Investigators will enroll 136 participants with primary bilateral symptomatic knee osteoarthritis that will refractory to conservative treatment who will undergo bilateral TKA under single anaesthesia after 15.06.2020. Investigators will include patients who were less than 75 years old, with no history of malignancy, without severe extra-articular deformities, and without the systemic inflammatory disease, severe cardiac insufficiency, and morbid obesity (>40 kg/m2 or 35 or more and experiencing obesity-related health conditions). An informed consent form will be obtained from all patients.
- Conditions
- Gonarthrosis; Primary
- Being tested
- Simultaneous bilateral total knee arthroplasty, Sequenced bilateral TKA
- Medical subject headings
- Osteoarthritis, Knee
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 surgeons bilateral TKA group
Sequenced bilateral TKAProcedure or surgery
Single surgeon bilateral TKA group
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous | 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.
Radiological examination
Coronal and Sagittal Alignment
Measured: 14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Jun 2020
- Primary completion30 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonarthrosis; PrimaryStudies 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
- 80 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
- NCT04434690
- Sponsor's protocol ID
- 71306642-050.01.04
- Status last verified
- Jun 2020
- First submitted
- 13 Jun 2020
- Last updated
- 17 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 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04434690
- Acronym / sponsor ID
- 71306642-050.01.04
- Conditions
- Gonarthrosis; Primary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 17 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.
Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral TKA), and single-stage, a sequential bilateral TKA (single surgeon bilateral TKA). The purpose of this study is to evaluate the radiological results in the single-stage bilateral TKA in terms of two surgeons bilateral TKA and single surgeon bilateral TKA.
Detailed description
Investigators will enroll 136 participants with primary bilateral symptomatic knee osteoarthritis that will refractory to conservative treatment who will undergo bilateral TKA under single anaesthesia after 15.06.2020. Investigators will include patients who were less than 75 years old, with no history of malignancy, without severe extra-articular deformities, and without the systemic inflammatory disease, severe cardiac insufficiency, and morbid obesity (>40 kg/m2 or 35 or more and experiencing obesity-related health conditions). An informed consent form will be obtained from all patients.
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 |
|---|---|---|
| Simultaneous | 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
- 35 to 75 years
- 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 less than 75 years old without severe extra-articular deformities severe cardiac insufficiency and morbid obesity without systemic inflammatory diseases
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 surgeons bilateral TKA group | Procedure or surgery | Simultaneous |
| Sequenced bilateral TKASingle surgeon bilateral TKA group | Procedure or surgery | Single surgeon bilateral TKA group |
Primary outcome
Radiological examination
Time frame: 14days
Coronal and Sagittal Alignment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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 Gonarthrosis; Primary, 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 17 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?
Contact Orkhan Aliyev, MD (+90 505 991 71 19, orkhanaliyev@outlook.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological examination (time frame: 14days). 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 17 Jun 2020.