Arthropathy of KneeNCT06259032
Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment
A study testing Mechanical alignment and Functional alignment in people with Arthropathy of Knee, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Arthropathy of Knee
- What is being tested?
- Mechanical alignment and Functional alignment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2023to 30 Jun 2024
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-80 years
- Symptomatic bilateral knee Osteoarthritis requiring primary TKA
- Willing to undergo bilateral simultaneous TKA
- Able to give informed consent
Who cannot join
- ligament deficiency requiring constrained prosthesis
- bone loss with augmentation need
- history of fracture around knee or previous osteotomy
- history of ankle fracture
- patient with neuromuscular disorder or movement disorder
- patient is unable to attend the study follow-up program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment : a Randomized Controlled Trial
Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. However, evaluation is focused mainly on knee alignment, the pathological findings and other adaptational changes in the ankles and hips are usually neglected.
Thia study aim to comparative effect between mechanical and functional alignment in patient undergone bilateral robotic TKA on ankle alignment and functional outcomes.
- Conditions
- Arthropathy of Knee
- Being tested
- Mechanical alignment, Functional alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical alignmentOther
Goal alignment in TKA with mechanical alignment, resection bone in perpendicular to mechanical axis of femur and tibia.
Functional alignmentOther
Goal alignment in TKA with functional alignment, resection of bone base on native joint line obliquity.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical alignment | Experimental | Not described Receives: Other: Mechanical alignment |
| Functional alignment | Experimental | Not described Receives: Other: Functional alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic outcomes : Hip-knee-ankle angle
angle in degree between line from center of head of Femur to intercondylar notch and line from tibial interspinous to center of tibial plafond
Measured: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Radiographic outcomes : Tibial plafond inclination
angle in degree between subchondral plate of distal tibial articular surface and vertical axis
Measured: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Radiographic outcomes :Talar inclination
angle in degree between talar dome and vertical axis
Measured: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Radiographic outcomes : Tibiotalar tilt angle
angle in degree between subchondral plate of distal tibial articular surface and talar dome
Measured: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Secondary outcomes (4)
Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS)
a questionnaire assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
evaluation of the clinical status of the ankle-hindfoot, both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points.
Measured: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Quality of Life score : EQ-5D-5L
assess patient five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, Index scores range from -0.42 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
Measured: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Forgotten Joint Score
consists of 12 questions and is transform on a 0-100 scale.The higher the score, the less the patient is aware of their affected joint when performing daily activities
Measured: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Oct 2023
- Primary completion30 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259032
- Sponsor's protocol ID
- 66156
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2024
- Last updated
- 21 Nov 2024
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06259032
- Acronym / sponsor ID
- 66156
- Conditions
- Arthropathy of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 Feb 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.
Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. However, evaluation is focused mainly on knee alignment, the pathological findings and other adaptational changes in the ankles and hips are usually neglected.
Thia study aim to comparative effect between mechanical and functional alignment in patient undergone bilateral robotic TKA on ankle alignment and functional outcomes.
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 |
|---|---|---|
| Mechanical alignment | Experimental | Other: Mechanical alignment |
| Functional alignment | Experimental | Other: Functional alignment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20-80 years
- Symptomatic bilateral knee Osteoarthritis requiring primary TKA
- Willing to undergo bilateral simultaneous TKA
- Able to give informed consent
Key exclusion criteria (6 listed)
- ligament deficiency requiring constrained prosthesis
- bone loss with augmentation need
- history of fracture around knee or previous osteotomy
- history of ankle fracture
- patient with neuromuscular disorder or movement disorder
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 |
|---|---|---|
| Mechanical alignmentGoal alignment in TKA with mechanical alignment, resection bone in perpendicular to mechanical axis of femur and tibia. | Other | Mechanical alignment |
| Functional alignmentGoal alignment in TKA with functional alignment, resection of bone base on native joint line obliquity. | Other | Functional alignment |
Primary outcome
Radiographic outcomes : Hip-knee-ankle angle
Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
angle in degree between line from center of head of Femur to intercondylar notch and line from tibial interspinous to center of tibial plafond
Radiographic outcomes : Tibial plafond inclination
Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
angle in degree between subchondral plate of distal tibial articular surface and vertical axis
Radiographic outcomes :Talar inclination
Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
angle in degree between talar dome and vertical axis
Radiographic outcomes : Tibiotalar tilt angle
Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
angle in degree between subchondral plate of distal tibial articular surface and talar dome
4 secondary outcomes
Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score
Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Quality of Life score : EQ-5D-5L
Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Forgotten Joint Score
Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical alignment and Functional alignment in people with Arthropathy of Knee, run by Department of Medical Services Ministry of Public Health of Thailand 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 21 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic outcomes : Hip-knee-ankle angle (time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks). The study lists 4 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 21 Nov 2024.