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

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

Study Overview

• Status: Active, not recruiting
• Conditions: TKA Outcomes
• Intervention / Treatment: Procedure: iKA

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • West
    • Bruges, West, Belgium, 8200
      • KULeuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: To examine the lower limb kinematic differences during the challenging daily functional movements, s; 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.	Procedure: iKA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Stadiometer; height in millimeters	2 years after TKA
Joint angles	Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit: Degrees	2 years after surgery
Age	year	2 years after TKA
Leg Length	Direct Tape Measure; Leg Length in millimeters	2 years after TKA
Inter-ASIS Dist	Vernier caliper， Inter-ASIS Dist in millimeters	2 years after TKA
Knee Width	Vernier caliper, Knee Width in millimeters	2 years after TKA
Ankle Width	Vernier caliper, Ankle Width in millimeters	2 years after TKA
Elbow Width	Vernier caliper, Elbow Width in millimeters	2 years after TKA
Wrist Width	Vernier caliper, Wrist Width in millimeters	2 years after TKA
Hand Thickness	Vernier caliper, Hand Thickness in millimeters	2 years after TKA
Total Gait Cycle Duration	Vicon Nexus 2.12 software (©Vicon Motion Systems Ltd., Oxford, UK); Unit in second	2 years after TKA
Visual Analog Scale	Pain Scores	Pre-TKA, 6 weeks after TKA, 2 years after TKA
Oxford Knee Score (OKS)	total score ranging from 0 to 48	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	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	2 years after TKA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	weight and height will be combined to report BMI in kg/m2	2 years after TKA

Collaborators and Investigators

• Sponsor: KU Leuven

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: TKA; iKA; aMA
• Other Study ID Numbers: S67874; B3222022001251 (Other Identifier: Ethics Committee Research UZ/KU Leuven)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: it is a 15 year study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No