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NCT Number: NCT07367802

Exploring the Benefits of a 3D Patient-specific Alignment in Total Knee Arthroplasty

General Aim: to explore the iKA in TKA related to clinical, biomechanical, and functional outcomes.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

TKA Outcomes

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KULeuven

Bruges, West, 8200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

iKA

Procedure

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.

Primary outcomes

  1. Height

    Time frame: 2 years after TKA

    Stadiometer; height in millimeters

  2. Joint angles

    Time frame: 2 years after surgery

    Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit: Degrees

  3. Age

    Time frame: 2 years after TKA

    year

  4. Leg Length

    Time frame: 2 years after TKA

    Direct Tape Measure; Leg Length in millimeters

  5. Inter-ASIS Dist

    Time frame: 2 years after TKA

    Vernier caliper， Inter-ASIS Dist in millimeters

  6. Knee Width

    Time frame: 2 years after TKA

    Vernier caliper, Knee Width in millimeters

  7. Ankle Width

    Time frame: 2 years after TKA

    Vernier caliper, Ankle Width in millimeters

  8. Elbow Width

    Time frame: 2 years after TKA

    Vernier caliper, Elbow Width in millimeters

  9. Wrist Width

    Time frame: 2 years after TKA

    Vernier caliper, Wrist Width in millimeters

  10. Hand Thickness

    Time frame: 2 years after TKA

    Vernier caliper, Hand Thickness in millimeters

  11. Total Gait Cycle Duration

    Time frame: 2 years after TKA

    Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit in second

  12. Visual Analog Scale

    Time frame: Pre-TKA, 6 weeks after TKA, 2 years after TKA

    Pain Scores

  13. Oxford Knee Score (OKS)

    Time frame: Pre-TKA; 2 years after TKA

    total score ranging from 0 to 48

  14. 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

  15. 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

Secondary outcomes

  1. BMI

    Time frame: 2 years after TKA

    weight and height will be combined to report BMI in kg/m2

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: iKA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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