Femoral Component Rotation and Its Impact on Patellofemoral Complications and Functional Outcomes in MAKO Robotic TKA: Prospective Randomized Controlled Trials

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260216006

Enrollment

Registered

2026-02-16

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary knee osteoarthritis OA knee

Interventions

Femoral component rotation will be fixed at 0 degrees TEA and then flexion gap balance will be done with other method,Femoral component rotation will be adjustable ranging from 0 degrees to 5 degrees

Experimental Procedure/Surgery,Experimental Procedure/Surgery

Fixed FCR at 0deg TEA in MAKO Robotic TKA,Adjustable FCR at 0-5deg TEA in MAKO Robotic TKA

Eligibility

Sex/Gender

All

Age

55 Years to No maximum

Inclusion criteria

Inclusion criteria: Age more or equal to 55 years Primary knee osteoarthritis Unilateral knee surgery Intact ligamentous structures and soft tissue envelope Independent preoperative ambulation without assistive devices History of knee pain more than 6 months Informed consent

Exclusion criteria

Exclusion criteria: Prior surgery on the ipsilateral knee Prior surgery on the contralateral knee within 90 days Secondary knee osteoarthritis Severe patellar dysplasia or alta, baja Requiring stemmed components or augmentation Severe coronal plane deformity > 15deg BMI > 40 kg/m2 or < 18 kg/m2 Presence of neurological, neuromuscular disorders

Design outcomes

Primary

Measure	Time frame
Lateral patellar tilt angle 6 weeks Lateral patellar tilt angle in plain film knee merchant view	—

Secondary

Measure	Time frame
Lateral patellar tilt angle 6 months Lateral patellar tilt angle in plain film knee merchant view,Lateral patellar tilt angle 12 months Lateral patellar tilt angle in plain film knee merchant view,Timed Up and Go (TUG) Test 2 weeks, 3 weeks, 3 months, 6 months, 12 months Measure by single assessor,Five Time Sit to Stand test (FTSST) 2 weeks, 3 weeks, 3 months, 6 months, 12 months Measure by single assessor,3-Minute Walk Test (3MWT) 2 weeks, 3 weeks, 3 months, 6 months, 12 months Measure by single assessor,The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 2 weeks, 3 weeks, 3 months, 6 months, 12 months Patient reported outcome using a questionnaire,Short Form (SF-12) 2 weeks, 3 weeks, 3 months, 6 months, 12 months Patient reported outcome using a questionnaire,Pain VAS 2 weeks, 3 weeks, 3 months, 6 months, 12 months Patient reported outcome using a questionnaire	—

Measure

Time frame

Lateral patellar tilt angle 6 months Lateral patellar tilt angle in plain film knee merchant view,Lateral patellar tilt angle 12 months Lateral patellar tilt angle in plain film knee merchant view,Timed Up and Go (TUG) Test 2 weeks, 3 weeks, 3 months, 6 months, 12 months Measure by single assessor,Five Time Sit to Stand test (FTSST) 2 weeks, 3 weeks, 3 months, 6 months, 12 months Measure by single assessor,3-Minute Walk Test (3MWT) 2 weeks, 3 weeks, 3 months, 6 months, 12 months Measure by single assessor,The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 2 weeks, 3 weeks, 3 months, 6 months, 12 months Patient reported outcome using a questionnaire,Short Form (SF-12) 2 weeks, 3 weeks, 3 months, 6 months, 12 months Patient reported outcome using a questionnaire,Pain VAS 2 weeks, 3 weeks, 3 months, 6 months, 12 months Patient reported outcome using a questionnaire

—

Countries

Thailand

Contacts

Public ContactHiran Rujipimolkit

King Chulalongkorn Memorial Hospital

hiran.ruj@chulahospital.org022564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026