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

N/AActive Not RecruitingNCT07367802

KU Leuven45 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

TKA Outcomes

Interventions

iKAPROCEDURE

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.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

KULeuven

Bruges, West, Belgium

Outcomes

Primary Outcomes

Height

Stadiometer; height in millimeters

Time frame: 2 years after TKA

Joint angles

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

Time frame: 2 years after surgery

Age

year

Time frame: 2 years after TKA

Leg Length

Direct Tape Measure; Leg Length in millimeters

Time frame: 2 years after TKA

Inter-ASIS Dist

Vernier caliper， Inter-ASIS Dist in millimeters

Time frame: 2 years after TKA

Knee Width

Vernier caliper, Knee Width in millimeters

Time frame: 2 years after TKA

Ankle Width

Vernier caliper, Ankle Width in millimeters

Time frame: 2 years after TKA

Elbow Width

Vernier caliper, Elbow Width in millimeters

Time frame: 2 years after TKA

Wrist Width

Vernier caliper, Wrist Width in millimeters

Time frame: 2 years after TKA

Hand Thickness

Vernier caliper, Hand Thickness in millimeters

Time frame: 2 years after TKA

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes