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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthropathy of Knee
• Intervention / Treatment: Other: Mechanical alignment; Other: Functional alignment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical alignment	Other: Mechanical alignment; Goal alignment in TKA with mechanical alignment, resection bone in perpendicular to mechanical axis of femur and tibia.
Experimental: Functional alignment	Other: Functional alignment; Goal alignment in TKA with functional alignment, resection of bone base on native joint line obliquity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic outcomes : Hip-knee-ankle angle	angle in degree between line from center of head of Femur to intercondylar notch and line from tibial interspinous to center of tibial plafond	pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Radiographic outcomes : Tibial plafond inclination	angle in degree between subchondral plate of distal tibial articular surface and vertical axis	pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Radiographic outcomes :Talar inclination	angle in degree between talar dome and vertical axis	pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Radiographic outcomes : Tibiotalar tilt angle	angle in degree between subchondral plate of distal tibial articular surface and talar dome	pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS)	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.	pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score	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.	pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Quality of Life score : EQ-5D-5L	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.	pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks
Forgotten Joint Score	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	pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other outcomes : soft tissue release	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)	intraoperative
Other outcomes : operative time	measured in minutes from skin incision to complete of skin suture	intraoperative
Other outcomes : blood loss	record in millilitre measured from Radivac drain	post operative with in 2 days
Other outcomes : pain score (Visual analog scale)	score from 0-10 (0 was no pain, 10 was worst pain )	post-operative at 2,4,8,12 weeks
Other outcomes : Range of knee motion	record in total degree of knee motion	post-operative at 2,4,8,12 weeks
complications	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.	post-operative at 2,4,8,12 weeks

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 66156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No