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

NCT07367802 | Active Not Recruiting DMC

• 2 other identifiers: S67874B3222022001251
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

TKA Outcomes

Keywords

TKA; iKA; aMA

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (1)

• BMI

  2 years after TKA

Study Arms (1)

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.

Procedure: iKA

Interventions

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.

To examine the lower limb kinematic differences during the challenging daily functional movements, s

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KULeuven

Bruges, West, 8200, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35513224 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KUleuven Brugge

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 26, 2026
• Study Start: February 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)