Skip to main content
OpenTrials
Completed

NCT Number: NCT06259032

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthropathy of Knee

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Ratchathewi, Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical alignment

Other

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

Functional alignment

Other

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

Primary outcomes

  1. Radiographic outcomes : Hip-knee-ankle angle

    Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

    angle in degree between line from center of head of Femur to intercondylar notch and line from tibial interspinous to center of tibial plafond

  2. Radiographic outcomes : Tibial plafond inclination

    Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

    angle in degree between subchondral plate of distal tibial articular surface and vertical axis

  3. Radiographic outcomes :Talar inclination

    Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

    angle in degree between talar dome and vertical axis

  4. Radiographic outcomes : Tibiotalar tilt angle

    Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

    angle in degree between subchondral plate of distal tibial articular surface and talar dome

Secondary outcomes

  1. Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

    a questionnaire assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

  2. Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score

    Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

    evaluation of the clinical status of the ankle-hindfoot, both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, with healthy ankles receiving 100 points.

  3. Quality of Life score : EQ-5D-5L

    Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

    assess patient five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, Index scores range from -0.42 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.

  4. Forgotten Joint Score

    Time frame: pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

    consists of 12 questions and is transform on a 0-100 scale.The higher the score, the less the patient is aware of their affected joint when performing daily activities

Other outcomes

  1. Other outcomes : soft tissue release

    Time frame: intraoperative

    intra-operative soft tissue release (medial collateral ligament release or others structure around knee) report with Yes (soft tissue release) or No (no soft tissue release)

  2. Other outcomes : operative time

    Time frame: intraoperative

    measured in minutes from skin incision to complete of skin suture

  3. Other outcomes : blood loss

    Time frame: post operative with in 2 days

    record in millilitre measured from Radivac drain

  4. Other outcomes : pain score (Visual analog scale)

    Time frame: post-operative at 2,4,8,12 weeks

    score from 0-10 (0 was no pain, 10 was worst pain )

  5. Other outcomes : Range of knee motion

    Time frame: post-operative at 2,4,8,12 weeks

    record in total degree of knee motion

  6. complications

    Time frame: post-operative at 2,4,8,12 weeks

    Yes (complications) or No ( no complications) if yes, will specified the complications complication such as bone fracture, wound dehiscence, surgical site infection, periprosthetic infection ,pulmonary embolism or other adverse outcomes that may or may not directly associated with the operation.

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment : a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.