Osteoarthritis, KneeNCT06323577
Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA
A study testing Restricted kinematic alignment and Mechanical alignment in people with Osteoarthritis, Knee and TKA, run by Thammasat University Hospital at 1 site in Thailand.
Trial summary
The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients. The main question[s] it aims to answer are: Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients? Does rKA have lower pain score… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, TKA
- What is being tested?
- Restricted kinematic alignment and Mechanical alignment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 14 Mar 2024to 31 May 2026
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80 years
- Diagnosis bilateral primary osteoarthritis of knee joint and undergo simultaneous bilateral total knee arthroplasty
- ASA classification I-II
Who cannot join
- Valgus deformity
- BMI > 40kg/m2
- History of previous knee surgery
- Active infection of the knee joint
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Thammasat University
Khlong Luang, Changwat Pathum Thani, 12120
Yot Tanariyakul, M.D., 663930257, y.tanariyakul@gmail.com
Nattapol Tammachote, M.D.
About this study
Official title: Comparison of Functional Outcomes in Restricted Kinematic Alignment and Mechanical Alignment in Robotic Assisted Simultaneous Bilateral Total Knee Arthroplasty. A Randomized Controlled Trial
The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.
The main question[s] it aims to answer are:
- Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?
- Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA.
- Conditions
- Osteoarthritis, Knee, TKA
- Being tested
- Restricted kinematic alignment, Mechanical alignment
- Keywords
- restrict kinematic alignment, mechanical alignment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restricted kinematic alignmentProcedure or surgery
TKA using restricted kinematic alignment under robotic assisted surgery (MAKO).
Mechanical alignmentProcedure or surgery
TKA using mechanical alignment under robotic assisted surgery (MAKO).
| Study group | Role | What they receive |
|---|---|---|
| Restricted kinematic alignment | Experimental | Not described Receives: Procedure: Restricted kinematic alignment |
| Mechanical alignment | Active comparator | Not described Receives: Procedure: Mechanical alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten joint score
Point 0-100 (0 mean worst, 100 mean best)
Measured: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Secondary outcomes (6)
Modified WOMAC score
Point 0-96 (0 mean best, 100 mean worst)
Measured: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Range of motion
Using long arm goniometer (degrees)
Measured: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Pain score
Using visual analog scale (0-10, 0 mean best, 10 mean worst)
Measured: every 6 hours for 2 days after surgery then once a day for 2 weeks after surgery then once a week until 3 months after surgery
Hip knee ankle angle
Evaluate by long radiograph (degrees)
Measured: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Complications
For example periprosthetic fracture, infection or aspetic loosening
Measured: Until 2 years after surgery
Incidence of soft tissue releasing
Record soft tissue releasing intraoperative
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start14 Mar 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yot Tanariyakul, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323577
- Sponsor's protocol ID
- TUH rKA vs MA TKA
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elbuluk AM, Jerabek SA, Suhardi VJ, Sculco PK, Ast MP, Vigdorchik JM. Head-to-Head Comparison of Kinematic Alignment Versus Mechanical Alignment for Total Knee Arthroplasty. J Arthroplasty. 2022 Aug;37(8S):S849-S851. doi: 10.1016/j.arth.2022.01.052. Epub 2022 Jan 31.
PubMed 35093548McEwen PJ, Dlaska CE, Jovanovic IA, Doma K, Brandon BJ. Computer-Assisted Kinematic and Mechanical Axis Total Knee Arthroplasty: A Prospective Randomized Controlled Trial of Bilateral Simultaneous Surgery. J Arthroplasty. 2020 Feb;35(2):443-450. doi: 10.1016/j.arth.2019.08.064. Epub 2019 Sep 5.
PubMed 31591010Van Essen J, Stevens J, Dowsey MM, Choong PF, Babazadeh S. Kinematic alignment results in clinically similar outcomes to mechanical alignment: Systematic review and meta-analysis. Knee. 2023 Jan;40:24-41. doi: 10.1016/j.knee.2022.11.001. Epub 2022 Nov 17.
PubMed 36403396
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional Outcomes in Restricted Kinematic Alignment and Mechanical Alignment in Robotic Assisted Simultaneous Bilateral Total Knee Arthroplasty. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06323577
- Acronym / sponsor ID
- TUH rKA vs MA TKA
- Conditions
- Osteoarthritis, Knee, TKA
- Keywords
- restrict kinematic alignment, mechanical alignment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Thammasat University HospitalUniversity, hospital or other
- Study start
- 14 Mar 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 21 Mar 2024 (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 goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.
The main question[s] it aims to answer are:
- Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?
- Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restricted kinematic alignment | Experimental | Procedure: Restricted kinematic alignment |
| Mechanical alignment | Active comparator | Procedure: Mechanical alignment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-80 years
- Diagnosis bilateral primary osteoarthritis of knee joint and undergo simultaneous bilateral total knee arthroplasty
- ASA classification I-II
Key exclusion criteria (4 listed)
- Valgus deformity
- BMI > 40kg/m2
- History of previous knee surgery
- Active infection of the knee joint
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 |
|---|---|---|
| Restricted kinematic alignmentTKA using restricted kinematic alignment under robotic assisted surgery (MAKO). | Procedure or surgery | Restricted kinematic alignment |
| Mechanical alignmentTKA using mechanical alignment under robotic assisted surgery (MAKO). | Procedure or surgery | Mechanical alignment |
Primary outcome
Forgotten joint score
Time frame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Point 0-100 (0 mean worst, 100 mean best)
6 secondary outcomes
Modified WOMAC score
Time frame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Range of motion
Time frame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Pain score
Time frame: every 6 hours for 2 days after surgery then once a day for 2 weeks after surgery then once a week until 3 months after surgery
Hip knee ankle angle
Time frame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery
Complications
Time frame: Until 2 years after surgery
Incidence of soft tissue releasing
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 35093548Elbuluk AM, Jerabek SA, Suhardi VJ, Sculco PK, Ast MP, Vigdorchik JM. Head-to-Head Comparison of Kinematic Alignment Versus Mechanical Alignment for Total Knee Arthroplasty. J Arthroplasty. 2022 Aug;37(8S):S849-S851. doi: 10.1016/j.arth.2022.01.052. Epub 2022 Jan 31.
- Background: PubMed 31591010McEwen PJ, Dlaska CE, Jovanovic IA, Doma K, Brandon BJ. Computer-Assisted Kinematic and Mechanical Axis Total Knee Arthroplasty: A Prospective Randomized Controlled Trial of Bilateral Simultaneous Surgery. J Arthroplasty. 2020 Feb;35(2):443-450. doi: 10.1016/j.arth.2019.08.064. Epub 2019 Sep 5.
- Background: PubMed 36403396Van Essen J, Stevens J, Dowsey MM, Choong PF, Babazadeh S. Kinematic alignment results in clinically similar outcomes to mechanical alignment: Systematic review and meta-analysis. Knee. 2023 Jan;40:24-41. doi: 10.1016/j.knee.2022.11.001. Epub 2022 Nov 17.
- 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 Restricted kinematic alignment and Mechanical alignment in people with Osteoarthritis, Knee and TKA, run by Thammasat University Hospital at 1 site in Thailand.
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 3 inclusion and 4 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 21 Mar 2024. 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 Thailand. 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?
Forgotten joint score (time frame: 6 weeks, 3months, 6 months, 1 year and 2 years after surgery). 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 NCT06323577, which also lists 3 linked publications.
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 21 Mar 2024.