Bilateral Knee OsteoarthritisNCT04975165
Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties
A study testing Total knee arthroplasty in people with Bilateral Knee Osteoarthritis, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty is a well-known treatment of the end-stage osteoarthritis of the knee. In the case of bilateral end-stage knee osteoarthritis, both of the knees need total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Bilateral Knee Osteoarthritis
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 May 2021to 31 Jan 2023
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of bilateral primary knee osteoarthritis Age 55 to 85 years Must be able to walk without support
Who cannot join
- Rheumatological joint diseases Previous knee surgery Neuromuscular diseases Unilateral knee osteoarthritis Insufficiency of knee collateral ligaments.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gulhane Teaching and Research Hospital
Ankara, 06010
Deniz Cankaya, Assoc.Prof., +90 542 6688056, cankayadeniz78@gmail.com
About this study
Official title: Comparison of Smart-phone Based Gait Analysis Between Simultaneous and Staged Total Knee Arthroplasties
Total knee arthroplasty is a well-known treatment of the end-stage osteoarthritis of the knee. In the case of bilateral end-stage knee osteoarthritis, both of the knees need total knee arthroplasty. Bilateral total knee arthroplasty could be performed simultaneously or staged according to the preference of the patients. Simultaneous total knee arthroplasty is defined as the replacement of both knees in a single surgery. The major advantage of simultaneous total knee arthroplasty this surgery is that it requires only one hospital stay and a rehabilitation period to recover both knees, but higher blood transfusion rates and thromboembolism risk are still major concerns. Therefore, in this comparative study, smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing simultaneous and staged total knee arthroplasty, at 3, 6, and 12 months postoperatively
Read the detailed description
Patients with bilateral end-stage knee osteoarthritis will be included in the current study. Bilateral total knee arthroplasty will be performed simultaneously or staged according to the preference of the patients. We will have two groups: staged total knee arthroplasty and simultaneous total knee arthroplasty groups. The patients will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (Knee Society Scores and Knee Injury and Osteoarthritis Outcome Score), life quality (SF-12), and smart-phone based gait analysis. All data will be calculated as mean and standard deviation values. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).
- Conditions
- Bilateral Knee Osteoarthritis
- Being tested
- Total knee arthroplasty
- Keywords
- Bilateral knee arthroplasty, Gait analysis, Smart-phone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Staged total knee arthroplasty | Experimental | Staged replacement of both knees in two separate surgeries. Receives: Procedure: Total knee arthroplasty |
| Simultaneous total knee arthroplasty | Experimental | Simultaneous replacement of both knees in a single surgery. Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
smart-phone based gait analysis
Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application
Measured: Change from preoperative gait analysis at 3rd month gait analysis
smart-phone based gait analysis
Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application
Measured: Change from 3rd month gait analysis at 6th month gait analysis
smart-phone based gait analysis
Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application
Measured: Change from 6th month gait analysis at 12th month gait analysis
Secondary outcomes (3)
Knee functional scores
Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )
Measured: Change from preoperative Knee Society Scores (KSS) at 3rd month Knee Society Score (KSS)
Knee functional scores
Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )
Measured: Change from 3rd month Knee Society Scores (KSS) at 6th month Knee Society Score (KSS)
Knee functional scores
Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )
Measured: Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start26 May 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Knee OsteoarthritisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Deniz CANKAYA, Gulhane Training and Research Hospital
- Investigators
- Deniz CANKAYA, Assoc.Prof., Study chair, Gulhane Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975165
- Sponsor's protocol ID
- 2021/16
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- 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 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Smart-phone Based Gait Analysis Between Simultaneous and Staged Total Knee Arthroplasties
- ClinicalTrials.gov ID
- NCT04975165
- Acronym / sponsor ID
- 2021/16
- Conditions
- Bilateral Knee Osteoarthritis
- Keywords
- Bilateral knee arthroplasty, Gait analysis, Smart-phone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 26 May 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 23 Jul 2021 (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.
Total knee arthroplasty is a well-known treatment of the end-stage osteoarthritis of the knee. In the case of bilateral end-stage knee osteoarthritis, both of the knees need total knee arthroplasty. Bilateral total knee arthroplasty could be performed simultaneously or staged according to the preference of the patients. Simultaneous total knee arthroplasty is defined as the replacement of both knees in a single surgery. The major advantage of simultaneous total knee arthroplasty this surgery is that it requires only one hospital stay and a rehabilitation period to recover both knees, but higher blood transfusion rates and thromboembolism risk are still major concerns. Therefore, in this comparative study, smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing simultaneous and staged total knee arthroplasty, at 3, 6, and 12 months postoperatively
Detailed description
Patients with bilateral end-stage knee osteoarthritis will be included in the current study. Bilateral total knee arthroplasty will be performed simultaneously or staged according to the preference of the patients. We will have two groups: staged total knee arthroplasty and simultaneous total knee arthroplasty groups. The patients will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (Knee Society Scores and Knee Injury and Osteoarthritis Outcome Score), life quality (SF-12), and smart-phone based gait analysis. All data will be calculated as mean and standard deviation values. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staged total knee arthroplasty | Experimental | Procedure: Total knee arthroplastyStaged replacement of both knees in two separate surgeries. |
| Simultaneous total knee arthroplasty | Experimental | Procedure: Total knee arthroplastySimultaneous replacement of both knees in a single surgery. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of bilateral primary knee osteoarthritis Age 55 to 85 years Must be able to walk without support
Key exclusion criteria (1 listed)
- Rheumatological joint diseases Previous knee surgery Neuromuscular diseases Unilateral knee osteoarthritis Insufficiency of knee collateral ligaments.
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 |
|---|---|---|
| Total knee arthroplastyBilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty | Procedure or surgery | Simultaneous total knee arthroplasty, Staged total knee arthroplasty |
Primary outcome
smart-phone based gait analysis
Time frame: Change from preoperative gait analysis at 3rd month gait analysis
Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application
smart-phone based gait analysis
Time frame: Change from 3rd month gait analysis at 6th month gait analysis
Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application
smart-phone based gait analysis
Time frame: Change from 6th month gait analysis at 12th month gait analysis
Gait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application
3 secondary outcomes
Knee functional scores
Time frame: Change from preoperative Knee Society Scores (KSS) at 3rd month Knee Society Score (KSS)
Knee functional scores
Time frame: Change from 3rd month Knee Society Scores (KSS) at 6th month Knee Society Score (KSS)
Knee functional scores
Time frame: Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- 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.
Deniz CANKAYA, Assoc.Prof. study chair
Gulhane Teaching and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Bilateral Knee Osteoarthritis, run by Gulhane Training and Research Hospital 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 29 Jul 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 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 Deniz Cankaya, Assoc.Prof. (+90 542 6688056, cankayadeniz78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smart-phone based gait analysis (time frame: Change from preoperative gait analysis at 3rd month gait analysis). The study lists 3 primary outcomes in all. 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 29 Jul 2021.