TKA OutcomesiKANCT07367802
Exploring the Benefits of a 3D Patient-specific Alignment in Total Knee Arthroplasty
A study testing iKA in people with TKA Outcomes, run by KU Leuven at 1 site in Belgium.
Trial summary
General Aim: to explore the iKA in TKA related to clinical, biomechanical, and functional outcomes. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- TKA Outcomes
- What is being tested?
- iKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- were age under 85 years. primary robot-assisted TKA using either iKA or aMA. surgery performed two years before enrollment. independent ambulation without assistive devices; and informed consent.
Who cannot join
- history of lower limb trauma or fracture. neurological disorders (e.g., stroke, Parkinson's disease, multiple sclerosis). systemic musculoskeletal diseases (e.g., rheumatoid arthritis, diabetic neuropathy).
- revision arthroplasty. and cognitive impairment affecting study participation.
Trial locations and contacts
1 site in 1 country.
About this study
General Aim: to explore the iKA in TKA related to clinical, biomechanical, and functional outcomes.
Read the detailed description
First specific aim: to investigate the kinematics during daily functional movements in individuals with the iKA TKA to those with aMA TKA, as well as the healthy control group.
Second specific aim: to investigate kinetics and muscle activation patterns during functional movements in individuals with the iKA aligned TKA to those with aMA TKA, as well as a healthy control group.
Third specific aim: to investigate the impact of the whole body on functional outcomes following iKA and aMA TKA, in comparison to the healthy control group, and to explore the underlying factors contributing to suboptimal outcomes.
- Conditions
- TKA Outcomes
- Being tested
- iKA
- Keywords
- TKA, iKA, aMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iKAProcedure or surgery
This study compared inverse kinematic alignment (iKA) TKA, which preserves native JLO, with adjusted mechanical alignment (aMA) TKA, which standardizes JLO to 90°, and a healthy control group across eight functional activities.
| Study group | Role | What they receive |
|---|---|---|
| To examine the lower limb kinematic differences during the challenging daily functional movements, s | Experimental | To examine the lower limb kinematic differences during the challenging daily functional movements, such as the lunge, in individuals who have undergone iKA TKA, compared to those with aMA TKA and healthy controls. Receives: Procedure: iKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Stadiometer; height in millimeters
Measured: 2 years after TKA
Joint angles
Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit: Degrees
Measured: 2 years after surgery
Age
year
Measured: 2 years after TKA
Leg Length
Direct Tape Measure; Leg Length in millimeters
Measured: 2 years after TKA
Inter-ASIS Dist
Vernier caliper， Inter-ASIS Dist in millimeters
Measured: 2 years after TKA
Knee Width
Vernier caliper, Knee Width in millimeters
Measured: 2 years after TKA
Ankle Width
Vernier caliper, Ankle Width in millimeters
Measured: 2 years after TKA
Elbow Width
Vernier caliper, Elbow Width in millimeters
Measured: 2 years after TKA
Wrist Width
Vernier caliper, Wrist Width in millimeters
Measured: 2 years after TKA
Hand Thickness
Vernier caliper, Hand Thickness in millimeters
Measured: 2 years after TKA
Total Gait Cycle Duration
Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit in second
Measured: 2 years after TKA
Visual Analog Scale
Pain Scores
Measured: Pre-TKA, 6 weeks after TKA, 2 years after TKA
Oxford Knee Score (OKS)
total score ranging from 0 to 48
Measured: Pre-TKA; 2 years after TKA
maximum voluntary isometric strength tests of the lower limb
Peak force measured with a hand-held dynamometer (Micro FET 2 Handheld Dynamometer, Hoggan, USA); Unit: Newtons
Measured: 2 years after TKA
Muscle activity patterns for eight muscles (gluteus medius, rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semitendinosus, tibialis anterior and gastrocnemius medialis)
A 16-channel telemetric wireless surface electromyography (EMG) system (Waveplus®, Cometa, Rome, Italy) operating at 1000 Hz was utilized. Unit: Volt
Measured: 2 years after TKA
Secondary outcomes (1)
BMI
weight and height will be combined to report BMI in kg/m2
Measured: 2 years after TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Feb 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TKA OutcomesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhijun li, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367802
- Sponsor's protocol ID
- S67874
- Other IDs
- B3222022001251
- Acronym
- iKA
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it is a 15 year study
Publications
Winnock de Grave P, Kellens J, Luyckx T, Tampere T, Lacaze F, Claeys K. Inverse Kinematic Alignment for Total Knee Arthroplasty. Orthop Traumatol Surg Res. 2022 Sep;108(5):103305. doi: 10.1016/j.otsr.2022.103305. Epub 2022 May 2.
PubMed 35513224
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Benefits of a 3D Patient-specific Alignment in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07367802
- Acronym / sponsor ID
- iKA / S67874
- Conditions
- TKA Outcomes
- Keywords
- TKA, iKA, aMA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 26 Jan 2026 (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.
General Aim: to explore the iKA in TKA related to clinical, biomechanical, and functional outcomes.
Detailed description
First specific aim: to investigate the kinematics during daily functional movements in individuals with the iKA TKA to those with aMA TKA, as well as the healthy control group.
Second specific aim: to investigate kinetics and muscle activation patterns during functional movements in individuals with the iKA aligned TKA to those with aMA TKA, as well as a healthy control group.
Third specific aim: to investigate the impact of the whole body on functional outcomes following iKA and aMA TKA, in comparison to the healthy control group, and to explore the underlying factors contributing to suboptimal outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To examine the lower limb kinematic differences during the challenging daily functional movements, s | Experimental | Procedure: iKATo examine the lower limb kinematic differences during the challenging daily functional movements, such as the lunge, in individuals who have undergone iKA TKA, compared to those with aMA TKA and healthy controls. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- were age under 85 years. primary robot-assisted TKA using either iKA or aMA. surgery performed two years before enrollment. independent ambulation without assistive devices; and informed consent.
Key exclusion criteria (2 listed)
- history of lower limb trauma or fracture. neurological disorders (e.g., stroke, Parkinson's disease, multiple sclerosis). systemic musculoskeletal diseases (e.g., rheumatoid arthritis, diabetic neuropathy).
- revision arthroplasty. and cognitive impairment affecting study participation.
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 |
|---|---|---|
| iKAThis study compared inverse kinematic alignment (iKA) TKA, which preserves native JLO, with adjusted mechanical alignment (aMA) TKA, which standardizes JLO to 90°, and a healthy control group across eight functional activities. | Procedure or surgery | To examine the lower limb kinematic differences during the challenging daily functional movements, s |
Primary outcome
Height
Time frame: 2 years after TKA
Stadiometer; height in millimeters
Joint angles
Time frame: 2 years after surgery
Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit: Degrees
Age
Time frame: 2 years after TKA
year
Leg Length
Time frame: 2 years after TKA
Direct Tape Measure; Leg Length in millimeters
Inter-ASIS Dist
Time frame: 2 years after TKA
Vernier caliper， Inter-ASIS Dist in millimeters
Knee Width
Time frame: 2 years after TKA
Vernier caliper, Knee Width in millimeters
Ankle Width
Time frame: 2 years after TKA
Vernier caliper, Ankle Width in millimeters
Elbow Width
Time frame: 2 years after TKA
Vernier caliper, Elbow Width in millimeters
Wrist Width
Time frame: 2 years after TKA
Vernier caliper, Wrist Width in millimeters
Hand Thickness
Time frame: 2 years after TKA
Vernier caliper, Hand Thickness in millimeters
Total Gait Cycle Duration
Time frame: 2 years after TKA
Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit in second
Visual Analog Scale
Time frame: Pre-TKA, 6 weeks after TKA, 2 years after TKA
Pain Scores
Oxford Knee Score (OKS)
Time frame: Pre-TKA; 2 years after TKA
total score ranging from 0 to 48
maximum voluntary isometric strength tests of the lower limb
Time frame: 2 years after TKA
Peak force measured with a hand-held dynamometer (Micro FET 2 Handheld Dynamometer, Hoggan, USA); Unit: Newtons
Muscle activity patterns for eight muscles (gluteus medius, rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semitendinosus, tibialis anterior and gastrocnemius medialis)
Time frame: 2 years after TKA
A 16-channel telemetric wireless surface electromyography (EMG) system (Waveplus®, Cometa, Rome, Italy) operating at 1000 Hz was utilized. Unit: Volt
1 secondary outcome
BMI
Time frame: 2 years after TKA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Results publication: PubMed 35513224Winnock de Grave P, Kellens J, Luyckx T, Tampere T, Lacaze F, Claeys K. Inverse Kinematic Alignment for Total Knee Arthroplasty. Orthop Traumatol Surg Res. 2022 Sep;108(5):103305. doi: 10.1016/j.otsr.2022.103305. Epub 2022 May 2.
- Individual participant dataSharing planned: No. it is a 15 year study
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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 iKA in people with TKA Outcomes, run by KU Leuven at 1 site in Belgium.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Height (time frame: 2 years after TKA). The study lists 15 primary outcomes in all. 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 NCT07367802, which also lists 1 linked publication.
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 26 Jan 2026.