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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07367802
Acronym
iKA
Enrollment
45
Registered
2026-01-26
Start date
2024-02-01
Completion date
2027-09-01
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TKA Outcomes

Keywords

TKA, iKA, aMA

Brief summary

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.

Interventions

PROCEDUREiKA

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.

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Hand Thickness2 years after TKAVernier caliper, Hand Thickness in millimeters
Visual Analog ScalePre-TKA, 6 weeks after TKA, 2 years after TKAPain Scores
Oxford Knee Score (OKS)Pre-TKA; 2 years after TKAtotal score ranging from 0 to 48
Total Gait Cycle Duration2 years after TKAVicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit in second
maximum voluntary isometric strength tests of the lower limb2 years after TKAPeak 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)2 years after TKAA 16-channel telemetric wireless surface electromyography (EMG) system (Waveplus®, Cometa, Rome, Italy) operating at 1000 Hz was utilized. Unit: Volt
Height2 years after TKAStadiometer; height in millimeters
Joint angles2 years after surgeryVicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit: Degrees
Age2 years after TKAyear
Leg Length2 years after TKADirect Tape Measure; Leg Length in millimeters
Inter-ASIS Dist2 years after TKAVernier caliper, Inter-ASIS Dist in millimeters
Knee Width2 years after TKAVernier caliper, Knee Width in millimeters
Ankle Width2 years after TKAVernier caliper, Ankle Width in millimeters
Elbow Width2 years after TKAVernier caliper, Elbow Width in millimeters
Wrist Width2 years after TKAVernier caliper, Wrist Width in millimeters

Secondary

MeasureTime frameDescription
BMI2 years after TKAweight and height will be combined to report BMI in kg/m2

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026