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

Arthropathy of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259032
• Other study ID #: 66156
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Rajavithi Hospital
• Contact: Ketkaewsuwan
• Phone: 0 2206 2900
• Email: fluk.zhaoyun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases

Intervention

Other:
• Mechanical alignment
Goal alignment in TKA with mechanical alignment, resection bone in perpendicular to mechanical axis of femur and tibia.
• Functional alignment
Goal alignment in TKA with functional alignment, resection of bone base on native joint line obliquity.

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Other outcomes : operative time	measured in minutes from skin incision to complete of skin suture	intraoperative
Other	Other outcomes : blood loss	record in millilitre measured from Radivac drain	post operative with in 2 days
Other	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	Other outcomes : Range of knee motion	record in total degree of knee motion	post-operative at 2,4,8,12 weeks
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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