Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-06-30

Brief Summary

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Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. However, evaluation is focused mainly on knee alignment, the pathological findings and other adaptational changes in the ankles and hips are usually neglected.

Thia study aim to comparative effect between mechanical and functional alignment in patient undergone bilateral robotic TKA on ankle alignment and functional outcomes.

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Detailed Description

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Conditions

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Arthropathy of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Mechanical alignment

Group Type EXPERIMENTAL

Mechanical alignment

Intervention Type OTHER

Goal alignment in TKA with mechanical alignment, resection bone in perpendicular to mechanical axis of femur and tibia.

Functional alignment

Group Type EXPERIMENTAL

Functional alignment

Intervention Type OTHER

Goal alignment in TKA with functional alignment, resection of bone base on native joint line obliquity.

Interventions

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Mechanical alignment

Goal alignment in TKA with mechanical alignment, resection bone in perpendicular to mechanical axis of femur and tibia.

Intervention Type OTHER

Functional alignment

Goal alignment in TKA with functional alignment, resection of bone base on native joint line obliquity.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 20-80 years
* Symptomatic bilateral knee Osteoarthritis requiring primary TKA
* Willing to undergo bilateral simultaneous TKA
* Able to give informed consent

Exclusion Criteria

* ligament deficiency requiring constrained prosthesis
* bone loss with augmentation need
* history of fracture around knee or previous osteotomy
* history of ankle fracture
* patient with neuromuscular disorder or movement disorder
* patient is unable to attend the study follow-up program

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No